General description of amendments on partial articles 
of “Regulations Governing Issuance of Medical Device 
License, Listing and Annual Declaration ” as well as 
Appendix 1 of Article 5, Appendices 2 and 3 of Article 
6 
The Regulations Governing Issuance of Medical Device License, Listing and 
Annual Declaration (hereinafter referred to as the Regulations) were released 
on April 29, 20 21 with Wei -Shou -Shi-Tzu No. 1101603144  order of the 
Ministry of Health and Welfare . Considering the rapid advancement of medical 
devices, to harmonize with international regulations, to improve Taiwan ’s 
practical management of medical devices, and to improv e administrative 
efficiency, partial articles of the Regulations as well as Appendix 1 of Article 
5, Appendices 2 and 3 of Article 6 have been  amended . Key points of the 
amendment are listed below:  
I. Added registration particulars of medical device licenses and amended 
regulations on medical devices that need to submit samples for testing.  
(Amended Article 3)  
II. Amended the designated deadline  to make corrections after the formality 
review of applications of medical device registration and market approval. 
(Amen ded Article 7)  
III. Added change of particulars to medical device licenses and amended the 
documents and information  to be submitted for applications of changes of 
particulars. (Amended Article 13)  
IV. Newly added a mutatis mutandis provision on applications for change of 
particulars of medical device licenses  that require submission of samples 
for testing . (Amended Article 13 -1) 
V. Added and amended the regulations to stipulate when medical device 
license holders can make changes of their own accord. (Amended Articl e 
14) 
VI. Amended the regulations governing the application for listing of medical devices and change of listing of medical devices, and added Appendix 5 
to list the documents and information  that should be uploaded for 
reference. (Amended Article s 20 and 21) 
VII. Documents and information  that shall be submitted for an application of 
registration and market approval to manufacture or import Class 1 medical 
devices  have been added . (Amended provisions in Appendix 1 of Article 
5 of the Regulations)  
VIII. Amended documents and information that shall be submitted for an 
application of registration and market approval to manufacture or import 
Class 2 or Class 3 medical devices and relevant instructions . (Amended 
provisions in Appendix 2 of Article 6 of the Regulation s) 
IX. Amended the title of Appendix 3 and a dded applicable product items for 
Class 2 medical device product comparison and preclinical test data 
conformity statement. (Amended provisions in Appendix 3 of Article 6 of 
the Regulations)  
 
  Comparison Table of Original and Amended Provisions 
in “Regulations Governing Issuance of Medical Device 
License, Listing and Annual Declaration ” 
Amended articles  Original articles  Description  
Article 3 Applicants who 
apply for a license 
issued by the 
registration and market 
approval to manufacture 
or import medical 
devices shall submit 
documents and 
information in 
accordance with the 
provisions of Articles 5 
and 6 and pay the fee to 
the central  competent 
authority for 
submission.  
To apply for the 
registration and market 
approval referred to in 
the preceding paragraph 
for items announced by 
the central competent 
authority, applicant s 
shall follow the testing 
notice issued by the 
central competent 
authority, pay the 
testing fee by the 
designated deadline, and 
submit sufficient 
samples necessary for 
testing to conduct 
testing procedures. 
However, this does not Article 3 Applicants who 
apply for a license 
issued by the 
registration and market 
approval to manufacture 
or import medical 
devices shall submit 
documents and 
information in 
accordance with the 
provisions of Articles 5 
and 6 and pay the fee to 
the central competent 
authority for 
submission.  
Applicants whose 
application of 
registration and market 
approval, as referred to 
in the preceding 
paragraph and needed to 
conduct testing in 
accordance with the 
provisions of the 
Regulations,  shall 
follow th e testing notice 
issued by the central 
competent authority, 
pay the testing fee by 
the designated deadline, 
and submit sufficient 
samples necessary for 
testing to conduct 1. Paragraph 2 has been 
amended to clarify that 
testing is required for 
items announced by 
the central competent 
authority  when 
applying for 
registration and market 
approval to 
manufacture or import 
medical devices . 
2. The manufacturing 
license number has 
been added as one of 
the particulars to be  
included in the 
registration particulars 
of medical device 
licenses.  apply to those 
exclusively  for export.  
Registration 
particulars for the 
license referred to in 
Paragraph 1 are as 
follows:  
1. Chinese and English 
product names.  
2. Name of the medical 
device firm.  
3. Name and address of 
the medical device 
manufacturer.  
4. Effectiveness, 
intended use, or 
indication.  
5. Ingredients, materials, 
structures, 
specifications, or 
model number of the 
medical device.  
6. Labels, instructions, 
or packaging.  
7. Manufacturing license 
number.  
8. Other registration 
particulars that have 
been designated by 
the central competent 
authority.  testing procedures. 
However, this does not 
apply to those 
exclusively for export.  
Registration 
particulars for the 
license referred to in 
Paragraph 1 are as 
follows:  
1. Chinese and English 
product names.  
2. Name of the medical 
device firm.  
3. Name and address of 
the medical device 
manufacturer.  
4. Effectiveness, 
intended use, or 
indication.  
5. Ingredients, materials, 
structures, 
specifications, or 
model number of the 
medical device.  
6. Labels, instructions, 
or packaging.  
7. Other registration 
particulars that have 
been designated by 
the central competent 
authority.  Article 7 After receiving 
an application of 
registration and market 
approval, the central 
competent authority 
shall conduct a 
formality review of 
application documents 
and information.  
If the formality 
review set forth in the 
preceding paragraph 
finds application 
documents and 
information are not 
ready such that 
corrections can be 
made, the central 
competent authority 
shall notify the 
applicant to make 
corrections within one 
month. Fail ure to make 
corrections by the 
designated deadline 
shall subject the 
application to rejection.  Article 7 After receiving 
an application of 
registration and market 
approval, the central 
competent authority 
shall conduct a 
formality review of 
application doc uments 
and information.  
If the formality 
review set forth in the 
preceding paragraph 
finds application 
documents and 
information are not 
ready such that 
corrections can be 
made, the central 
competent authority 
shall notify the 
applicant to make 
correction s within four 
months. Failure to make 
corrections by the 
designated deadline 
shall subject the 
application to rejection.  The provision on the 
formality review of 
applications of registration 
and market approval of 
medical devices has been 
amended to improve the 
review efficiency , to 
prevent manufacturers 
from submitting 
applications before all 
required documents and 
information  are complete, 
and to avoid wasting 
reviewers ’ effort  review ing 
applications with 
incomplete documents and 
information .  
Article 13 If registration 
particulars of the 
license, labels, 
instructions, or 
packaging are changed 
relating to any of the 
following 
subparagraphs, 
documents and 
information in 
Appendix 4 shall be Article 13 If registration 
particulars of the 
license, labels, 
instructions, or 
packaging are changed 
relating to any of the 
following 
subparagraphs, 
documents and 
information in 
Appendix 4 shall be As the manufacturing 
license number has been 
added as one of the 
particulars to be included 
in the registration 
particulars of medical 
device licenses  in Article 
3, it has been added as one 
of the particulars to be 
included in applications 
for change of particulars submitted and fee shall 
be paid for submission 
of an applicat ion to the 
central competent 
authority:  
1. Chinese product 
name.  
2. English product 
name.  
3. Labels, 
instructions , or 
packaging.  
4. Ingredients, 
materials, 
structures, 
specifications , or 
model number.  
5. Effectiveness, 
intended use, or 
indication.  
6. Name of the 
manufacturer.  
7. Address of the 
manufacturer or 
country of 
manufacture.  
8. License holder.  
9. Name of the 
license holder.  
10. Manufacturing 
license number.   
When the approved 
document of license or 
labels, instructions, or 
packaging is lost or 
damaged, documents 
and information in 
Appendix 4 shall be submitted and fee shall 
be paid for submission 
of an application to the 
central competent 
authority:  
1. Chinese product 
name . 
2. English product 
name.  
3. Labels, 
instructions , or 
packaging.  
4. Ingredients, 
materials, 
structures, 
specifications , or 
model number.  
5. Effectiveness, 
intended use, or 
indication.  
6. Name of the 
manufacturer.  
7. Address of the 
manufacturer or 
country of 
manufacture .  
8. License holder.  
9. Name of the 
license holder  
When the approved 
document of license or 
labels, instructions, or 
packaging is lost or 
damaged, documents 
and information in 
Appendix 4 shall be 
submitted and fee shall 
be paid to apply for of medical device licenses.  submitted and fee shall 
be paid to apply for 
replacement or re -
issuance.  
If the central 
competent authority 
finds that documents 
and information referred 
to in the preceding two 
paragraphs are not ready 
such that corrections 
can be made, it shall 
notify the applicant to 
make corrections within 
three months. Failure to 
make corrections by the 
designated deadline 
shall subject the 
application to rejection.  
For applications of 
re-issuance or 
replacement of license 
as referred to in 
Paragraph 2, the 
applicant shall, within 
three months after the 
arrival date of the 
notice, pay the license 
fee and obtain the 
license fr om the central 
competent authority. 
Failure to obtain the 
license by the deadline 
may subject its license 
to cancellation by the 
central competent 
authority.  replacement or re -
issuance.  
If the central 
competent authority 
finds that documents 
and information referred 
to in the preceding two 
paragraphs are not ready 
such that corrections 
can be made, it shall 
notify the applicant to 
make corrections within 
three months. Failure to 
make corrections by the 
designated deadline 
shall subject the 
application to rejection.  
For applications of 
re-issuance or 
replacement of license 
as referred to in 
Paragraph 2, the 
applicant shall, within 
three months after the 
arrival date of the 
notice, pay the license 
fee and obtain the 
license fr om the central 
competent authority. 
Failure to obtain the 
license by the deadline 
may subject its license 
to cancellation by the 
central competent 
authority.  
For applications 
referred to in 
Paragraphs 1 and 2, the For applications 
referred to in 
Paragraphs 1 and 2, the 
central competent 
authority shall annotat e 
the original license with 
the changed registration 
particulars and date, and 
return it after stamping.  central competent 
authority shall annotat e 
the original license with 
the changed registration 
particulars and date, and 
return it after stamping.  
Article 13 -1 For items 
announced by the 
central competent 
authority to apply for 
the change referred to in 
Subp aragraph 4 or 7 of 
Paragraph 1 of the 
preceding article, the 
provisions of Paragraph 
2 of Article 3 shall 
apply mutatis mutandis .  1. This Article is newly 
added.  
2. To specify that testing 
is required for items 
announced by the 
central competent 
authority when 
apply ing for the 
change referred to in 
Subparagraph 4 or 7 of 
Paragraph 1 of Article 
13. 
Article 14 Under any of 
the following 
circumstances, license 
holders may, of their 
own accord, change 
labels, instructions, or 
packaging of the 
medical devices, and 
such changes shall be 
documented 
accordingly:  
1. No changes in the 
text content:  
(1)  Only changing 
the material, 
shape, graphic 
design, color or Article 14 Under any of 
the following 
circumstances, license 
holders may, of their 
own accord, change 
labels, instructions, or 
packaging of the 
medical devices, and 
such changes shall be 
documented 
accordingly:  
1. No changes in the 
text content:  
(1)  Only changing 
the mat erial, 
shape, graphic 
design, color or 1. As all items listed in 
Subparagraph 2 are no t 
related to the quality 
and safety of medical 
devices, the wording 
has been changed to 
remove the restriction 
and for clarity of the 
regulations.  
2. As the management of 
medical device  
manufacturer s has 
been changed from 
Good Manufacturing 
Practice (GMP) to 
Quality Management 
System ( QMS ), it has luster of labels, 
instructions, or 
outer box and 
the graphic 
design not being 
offensive, 
indecent, or 
misleading.  
(2)  Due to different 
packaging 
quantities, 
resizing the 
approved 
graphic design 
or text to fit a 
different size of 
packaging, or 
repositioning the 
approved 
graphic design 
or text.  
(3)  Changing the 
fonts of the 
approved text, 
and its font size 
of English text 
not being larger 
than that of 
Chinese text for 
the product 
name.  
(4)  Adding printings 
on outer boxes 
or using new 
outer boxes to 
replace the 
affixed labels, 
and their design luster of labels, 
instructions, or 
outer box and 
the graphic 
design not being 
offensive, 
indecent, or 
misleading.  
(2)  Due to different 
packaging 
quantities, 
resizing the 
approved 
graphic design 
or text to fit a 
different  size of 
packaging, or 
repositioning the 
approved 
graphic design 
or text.  
(3)  Changing the 
fonts of the 
approved text, 
and its font size 
of English text 
not being larger 
than that of 
Chinese text for 
the product 
name.  
(4)  Adding printings 
on outer boxes 
or using  new 
outer boxes to 
replace the 
affixed labels, 
and their design been added in Item 1 
of Subparagraph 2, so 
manufacturers can 
change the wording of 
QMS of their own 
accord on the 
condition that the 
manufacturing license 
has been obtained ; 
information about 
representatives in other 
countries or areas has 
been added as an item 
that can be changed by 
manufacturers of their 
own accord.  
3. Considering 
international 
regulations on the 
labeling of medical 
devices, Item 5 of 
Subparagraph 2 is 
newly  added. On the 
condition that such 
particulars comply 
with regulations for the 
approval and 
registration of the 
license, international 
labeling symbols 
representing the 
particulars can be 
changed by 
manufacturers of their 
own accord to 
facilitate complianc e. 
4. The central competent 
authority may, based of text and 
graphs being 
identical to those 
in the originally 
approved labels.  
2. Changes o f the 
following text 
content : 
(1)  Adding or 
changing 
barcode, 
recycling mark, 
“QMS/ GMP ” 
characters of a 
medical device 
QMS/ GMP 
manufacturer, 
CE mark, 
suggested retail 
price, customer 
service 
telephone line, 
manufacturer ’s 
telephone 
number, fax 
number, contact 
office, copyright 
registration 
number or 
company 
trademark 
approved by 
Taiwan 
Intellectual 
Property Office, 
CNS mark or 
trademark 
registration of text and 
graphs being 
identical to those 
in the originally 
approved labels.  
2. Changes of the 
following text 
content  that do not 
relate to the quality 
and safety of 
medical devices:  
(1)  Adding or 
changing 
barcode, 
recycling mark, 
“GMP ” 
characters of a 
medical device 
GMP 
manufacturer, 
CE mark, 
suggested retail 
price, customer 
service 
telephone line, 
manufacturer ’s 
telephone 
number, fax 
number, contact 
office, copyright 
registration 
number or 
company 
trademark 
approved by 
Taiwan 
Intellectual 
Property Office, on the discovery of 
new facts and to 
protect the health and 
interests of the public, 
require the addition, 
deletion, or change of 
text on labels, 
instructions, or 
packaging of medical 
devices. For rapid and 
effective transmission 
of information, 
Subparagraph 3 is 
added . number, 
information of  
representative in 
other countries 
or areas . 
(2)  Adding or 
changing 
distributor ’s 
name or address, 
and the font size 
of distributor ’s 
name not larger 
than that of 
medical device 
manufacturer ’s 
(license 
holder ’s) name.  
(3)  Adding or 
changing the 
name of medical 
device firm, or 
the name or 
address of 
manufacturer 
that has been 
approved for 
change by  the 
central 
competent 
authority.  
(4)  Adding,  
deleting, or 
changing the 
name of medical 
device firm that 
has been 
approved for 
change by the CNS mark or 
trademark 
registration 
number.  
(2)  Adding or 
changing 
distributor ’s 
name or address, 
and the font s ize 
of distributor ’s 
name not larger 
than that of 
medical device 
manufacturer ’s 
(license 
holder ’s) name.  
(3)  Adding or 
changing the 
name of medical 
device firm, or 
the name or 
address of 
manufacturer 
that has been 
approved for 
change by the 
central 
competent 
authority.  
(4)  Adding, 
deleting, or 
changing the 
name of  medical 
device firm that 
has been 
approved for 
change by the 
central  central 
competent 
authority and 
that constitutes 
part of the 
Chinese and 
English product 
names.  
(5) Adding, deleting 
or changing 
international 
symbols 
representing 
approval and 
registration 
particulars on 
the license.  
3. Adding, deleting or 
changing the 
content according 
to the 
announcements 
made in 
accordance with 
Subparagraph 10, 
Paragraph 1, 
Article 33 of the 
Act. competent 
authority and 
that constitutes 
part of the 
Chinese and 
English product 
names.  
Article 20 Applicants who 
apply for a listing to 
manufacture or import 
medical devices shall 
list the following 
documents and 
information in the 
medical device listing 
system  (hereinafter 
referr ed to as “the Article 20 Applicants who 
apply for a listing to 
manufacture or import 
medical devices shall 
list the following 
documents and 
information in the 
medical device listing 
system (hereinafter 
referred to as “the To improve the 
management of the 
medical device listing 
system, the regulations on 
uploading documents and 
information  for reference 
when applying for a listing 
to manufacture or import 
medical devices has been 
amended. Appendix 5 Listing System ”) 
established by the 
central competent 
authority,  upload 
relevant documents and 
information as 
stipulated in Appendix 5  
and pay the fee to 
obtain a listing number:  
1. Chinese and 
English product 
names.  
2. Name of the 
medical device 
firm.  
3. Name and address 
of the 
manufacturer.  
4. Item name and 
number of the 
medical device 
classification.  
5. Sterility condition 
of the medical 
device.  
6. Status of the 
manufacturer in 
conforming to the 
Medical Device 
Quality 
Manageme nt 
System 
Regulations.  
7. Other documents 
and information 
designated by the 
central competent 
authority.  Listing System ”) 
established by the 
central competent 
authority and pay the  
fee to obtain a listing 
number:  
1. Chinese and 
English product 
names.  
2. Name of the 
medical device 
firm.  
3. Name and address 
of the 
manufacturer.  
4. Item name and 
number of the 
medical device 
classification.  
5. Sterility condition 
of the medical 
device.  
6. Status of the 
manufacturer in 
conforming to the 
Medical Device 
Quality 
Management 
System 
Regulations.  
7. Other documents 
and information 
designated by the 
central competent 
authority.  
The provisions of 
Article 4 shall apply 
mutatis mutandis to the have been added to 
explicitly list the 
documents and 
information  that should be 
uploaded when applying 
for a listing of a medical 
device.  The provisions of 
Article 4 shall apply 
mutatis mutandis to the 
product names of 
medical devices in the 
preceding paragraph.  product names of 
medical devices in the 
preceding paragraph.  
Article 21 With the 
exception of 
Subparagraph 4, those 
that change the listing 
particula rs of any 
subparagraph referred to 
in Paragraph 1 of the 
preceding article shall 
apply for the change in 
the Listing System and 
pay the fee.  
For the 
aforementioned 
application of change, 
the previous Article 
shall appl y mutatis 
mutandis for applicants 
to upload the documents 
and information.   
Changes to name 
of the medical device 
firm referred to in 
Subparagraph 2 of 
Paragraph 1 of the 
preceding article shall 
be limited to those that 
do not involve transfer 
of rights.  
Changes to item 
name and number of the 
medical device 
classification referred to Article 21 With the 
exception of 
Subparagraph 4, those 
that change the listing 
particulars of any 
subparagraph referred to 
in Paragraph 1 of the 
preceding article shall 
apply for the change in 
the Listing System and 
pay the fee.  
Changes to name 
of the medical device 
firm referred to in 
Subparagraph 2 of 
Paragraph 1 of the 
preceding ar ticle shall 
be limited to those that 
do not involve transfer 
of rights.  
Changes to item 
name and number of the 
medical device 
classification referred to 
in Subparagraph 4 of 
Paragraph 1 of the 
preceding article shall 
not apply for a listing 
change.  Paragra ph 2 has been 
added in accordance with 
Article 20 to specify that 
to apply for a change of a 
listing of a medical device, 
the previous Article shall 
be applied mutatis 
mutandis and applicants 
shall upload the 
documents and 
information.  The 
remaining paragraphs have 
been adjusted accordingly.  in Subparagraph 4 of 
Paragraph 1 of the 
preceding article shall 
not apply for a listing 
change.  
Article 26 The Regulations 
shall be implemented on 
May 1, 2021.  
Amendments to the 
Regulations shall be 
implemented on the date 
of promulgation.   Article 26 The Regulations 
shall be implemented on 
May 1, 2021.  
 Paragraph 2 is added to 
specify the effective date 
of the amendments of the 
Regulations.   
 
 
 
 Comparison Table of O riginal and Amended Provisions in Appendix 1 of Article 5  
Amended provisions  Original provisions  Description  
Appendix 1: Documents and information that shall be 
submitted for an application of registration and market 
approval to manufacture or import Class 1 medical devices  
   Application Category  
Item Manufacture  Import  
1 Application form for Class 1 
medical device registration 
and market approval  ○ ○ 
2 Copy of the medical device 
business permit  ○ ○ 
3 Document verifying that 
medical device manufacturer 
conforms to the Medical 
Device Quality Management 
System Regulations  △ △ 
4 Instructions of product from 
the original manufacturer  △ △ 
5 Test specifications and 
methods for preclinical  
testing and the test reports  △ △ Append ix 1: Documents and information that shall be 
submitted for an application of registration and market 
approval to manufacture or import Class 1 medical devices  
Application Category  
Item Manufacture  Import  
1 Application form for Class 1 
medical device registration 
and market approval  ○ ○ 
2 Copy of the medical device 
business permit  ○ ○ 
3 Document verifying that 
medical device manufacturer 
conforms to the Medical 
Device Quality Management 
System Regulations  △ △ 
4 Instructions of product from 
the original manufacturer  △ △ 
5 Test specifications and 
methods for preclinical  
testing and the test reports  △ △ Change of 
wording of 
Section 6 of 
the 
Instructions 
and relevant 
documents and 
information 
that should be 
submitted have 
been added for 
clarity and for 
applicants to 
follow.  6 Other documents and 
information designated  by the 
central competent authority  △ △ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  
△: Indicates it would be dependent on the case.  
2. Copy of the medical device business permit : 
(1)  Those who manufacture medical devices shall 
attach a copy of the medical device 
manufacturing permit. Those w ho import 
medical devices  shall  attach a copy of the 
medical device dealer permit showing that the 
business category includes “medical device 
import .”  
(2)  For domestic contract manufacturing, both the 
contract party and the contract manufacturer ’s 
medical device business permits shall be 
submitted.   
3. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations: This document refers to a copy of  
the certification document issued by the central 
competent authority stating that the medical device 
manufacturer conforms to the Medical Device Quality 6 Other documents and 
information designated by the 
central competent authority  △ △ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  
△: Indicates it would  be depend ent on the case.  
2. Copy of the medical device business permit : 
(1)  Those who manufacture medical devices shall 
attach a copy of the medical device 
manufactur ing permit . Those who import 
medical devices shall  attach a copy of the 
medical device dealer permit showing that the 
business category  includes “medical device 
import .”  
(2)  For domestic contract manufacturing, both the 
contract party and the contract manufacturer ’s 
medical device business permits shall be 
submitted.   
3. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations: This document refers to a copy of  
the certification document issued by the central 
competent authority stating that the medical device 
manufacturer conforms to the Medical Device Quality Management System Regulations. However, this shall 
not be required for items that, as product items 
announc ed by the central competent authority, do not 
need to obtain  manufacturing license.   
4. Instructions of product from the original manufacturer: 
They shall include the instructions for use, function, 
working principle, explanation of product composition 
(or in gredients), and the contents of which shall be 
sufficient to determine that the medical product meets 
the identification of Class 1 classification.   
5. Test specifications and methods of preclinical testing 
and the test reports: These documents shall be submi tted 
if the product performance/specifications have been 
described in the identification provisions of Class 1 
medical device product items or announced by the 
central competent authority pursuant to Article 30 of the 
Act.  
6. Other documents  and information  designated by the 
central competent authority : 
(1)  If the product name bears a trademark, relevant 
information related to trademark registration shall 
be submitted. If the product name bears the name 
or trademark of another firm, a consent letter 
issued by the  firm shall be submitted.  Management System Regulations. However, this shall 
not be required for items that, as product items 
announc ed by the central competent authority, do not 
need to obtain manufacturing license.   
4. Instructions of product from the original manufacturer: 
They shall include the instructions for use, function, 
working principle, explanation of product composition 
(or in gredients), and the contents of which shall be 
sufficient to determine that the medical product meets 
the identification of Class 1 classification.   
5. Test specifications and methods of preclinical testing 
and the test reports: These documents shall be submi tted 
if the product performance/specifications have been 
described in the identification provisions of Class 1 
medical device product items or announced by the 
central competent authority pursuant to Article 30 of the 
Act.  
6. The central competent authority may, depending on the 
circumstances of the case, request relevant documents 
and information be submitted : 
(1)  If the product name bears a trademark, relevant 
information related to trademark registration 
shall be submitted. If the product name bears the 
name o r trademark of another firm, a consent 
letter issued by the firm shall be submitted.   (2)  In line with the Consolidated List of 
Commodities Subject to Import Restriction and 
Commodities Assisted by Customs for Import 
Examination announced by the Bureau of Foreign 
Trade of the Ministry of Economic Affairs, 
medical devi ces imported from China shall first 
obtain permit for import from the Bureau of 
Foreign Trade of the Ministry of Economic 
Affairs before applying for registration and 
market approval from the central competent 
authority.  
(3) If the name of the product bears a proper noun for 
performance/specification of a specific country or 
international organization standards, supporting 
documents issued by the country or the region, a 
third -party validation agency, or the international 
organization should be attached.  (2)  In line with the Consolidated List of 
Commodities Subject to Import Restriction and 
Commodities Assisted by Customs for Import 
Examination announced by the Bureau of 
Foreign Trade of the Ministry of Economic 
Affairs, medical devices imported from China 
shall first obtain permit for import from the 
Bureau of Foreign Trade of the Ministry of  
Economic Affairs before applying for 
registration and market approval from the central 
competent authority.   
  
 Comparison Table of Original and Amended Provisions in Appendix 2 of Article 6  
Amended provisions  Original provisions  Description  
Appendix 2 : Documents and information that shall be submitted 
for an application of registration and market approval to 
manufacture or import Class 2 or Class 3 medical devices  
 
   Application  
     Category  
 
 
 
 
 
 
Documents and 
Information to 
be Submitted  Class 2  
Medical 
Devices  Class 3  
Medical 
Devices  Same 
Product 
with 
Different 
Product 
Names  Exclusively 
for Export  
Manufacture  Import  Manufacture  Import  Manufacture  Import  Manufacture  
1 Application 
form for 
medical device 
registration 
and market 
approval  ○ ○ ○ ○ ○ ○ ○ 
2 Two copies of 
draft labels, 
instructions , or 
packaging  ○ ○ ○ ○ ○ ○ ╳ 
3 Copy of the 
medical device 
business 
permit  ○ ○ ○ ○ ○ ○ ○ Appendix 2 : Documents and information that shall be submitted 
for an application of registration and market approval to 
manufacture or import Class 2 or Class 3 medical devices  
 
   Application  
     Category  
 
 
 
 
 
 
Documents and 
Information to 
be Submitted  Class 2  
Medical 
Devices  Class 3  
Medical 
Devices  Same 
Product 
with 
Different 
Product 
Names  Exclusively 
for Export  
Manufacture  Import  Manufacture  Import  Manufacture  Import  Manufacture  
1 Application 
form for 
medical device 
registration 
and market 
approval  ○ ○ ○ ○ ○ ○ ○ 
2 Two copies of 
draft labels, 
instructions , or 
packaging  ○ ○ ○ ○ ○ ○ ╳ 
3 Copy of the 
medical device 
business 
permit  ○ ○ ○ ○ ○ ○ ○ 1. Following the 
amendment of 
the provision 
of Paragraph 2 
of Article 3 on 
product s that 
require testing, 
Item 16 of 
“Documents 
and 
Information to 
be Submitted ” 
has been 
amended.  
2. Change of 
wording of 
Item 3, 
Subp aragraph 
2, Section 4 of 
the 
Instructions.  
3. Added new 
applicable 
items in 
accordance 
with Appendix 
3. For practical 
management, 4 Original of the 
manufacture 
and free sale 
certificate of 
the country of 
origin  ╳ △ ╳ △ ╳ ○ ╳ 
5 Original of the 
foreign 
original 
manufacturer 
authorization 
letter  ╳ ○ ╳ ○ ╳ ○ ╳ 
6 Documen t 
verifying that 
medical device 
manufacturer 
conforms to 
the Medical 
Device Quality 
Management 
System 
Regulations  ○ ○ ○ ○ ╳ ╳ ○ 
7 Test 
specifications 
and methods of 
preclinical 
testing and 
quality control 
conducted by 
the original 
manufacturer, 
the original △ △ ○ ○ ╳ ╳ ╳ 4 Original of the 
manufacture 
and free sale 
certificate of 
the country of 
origin  ╳ △ ╳ △ ╳ ○ ╳ 
5 Original of the 
foreign 
original 
manufacturer 
authorization 
letter  ╳ ○ ╳ ○ ╳ ○ ╳ 
6 Document 
verifying that 
medical device 
manufacturer 
conforms to 
the Medical 
Device Quality 
Management 
System 
Regulations  ○ ○ ○ ○ ╳ ╳ ○ 
7 Test 
specifications 
and methods of 
preclinical 
testing and 
quality control 
conducted by 
the original 
manufacturer, 
the original △ △ ○ ○ ╳ ╳ ╳ the provisions 
of 
Subp aragraph 
3 of Section 7 
of the 
Instructions 
have been 
amended.  
4. Section 13 of 
the 
Instructions 
added that if 
the name, the 
label, 
instructions or 
packaging of 
the product 
bears a proper 
noun for 
performance/ 
specification 
of a specific 
country or 
international 
organization 
standards, 
supporting 
docume nts 
should be 
attached . 
5. Amended 
Section 14 of test records, 
and the test 
reports  
8 Documents 
relating to 
product 
structures, 
materials, 
specifications, 
functions, 
intended uses, 
and drawings  ○ ○ ○ ○ ╳ ╳ ╳ 
9 Clinical 
evidence 
information  △ △ △ △ ╳ ╳ ╳ 
10 Radiation 
safety 
information for 
equipment 
generating 
ionizing 
radiation  △ △ △ △ ╳ ╳ ╳ 
11 Essential 
Principles (EP) 
of Safety and 
Performance 
of Medical 
Devices and 
Summary 
Technical 
Documentation 
(STED)  ╳ △ ○ ○ ╳ ╳ ╳ test records, 
and the test 
reports  
8 Documents 
relating to 
product 
structures, 
materials, 
specifications, 
functions, 
intended uses, 
and drawings  ○ ○ ○ ○ ╳ ╳ ╳ 
9 Clinical 
evidence 
information  △ △ △ △ ╳ ╳ ╳ 
10 Radiation 
safety 
information for 
equipment 
generating 
ionizing 
radiation  △ △ △ △ ╳ ╳ ╳ 
11 Essential 
Principles (EP) 
of Safety and 
Performance 
of Medical 
Devices and 
Summary  
Technical 
Documentation 
(STED)  ╳ △ ○ ○ ╳ ╳ ╳ the 
Instructions to 
clearly specify 
that products 
that require 
testing are 
items 
announced in 
accordance 
with Paragraph 
2 of Article 3.  12 Original of the 
manufacturer’s 
letter 
explaining that 
the product is 
the same 
product with 
different 
product names  ╳ ╳ ╳ ╳ ○ ○ ╳ 
13 Copy of the 
originally 
approved 
labels, 
instructions, or 
packaging 
stamped with 
tally 
impression of 
the central 
competent 
authority  ╳ ╳ ╳ ╳ ○ ○ ╳ 
14 Copy of the 
originally 
approved 
medical device 
license  ╳ ╳ ╳ ╳ ○ ○ ╳ 
15 Other 
documents and 
information 
designated by 
the central △ △ △ △ △ △ △ 12 Original of the 
manufacturer’s 
letter 
explaining that 
the product is 
the same 
product with 
different 
product names  ╳ ╳ ╳ ╳ ○ ○ ╳ 
13 Copy of the 
originally 
approved 
labels, 
instructions, or 
packaging 
stamped with 
tally 
impression of 
the central 
competent 
authority  ╳ ╳ ╳ ╳ ○ ○ ╳ 
14 Copy of the 
originally 
approved 
medical device 
license  ╳ ╳ ╳ ╳ ○ ○ ╳ 
15 Other 
documents and 
information 
designated by 
the central △ △ △ △ △ △ △ competent 
authority  
16 Samples for 
testing  △ △ △ △ ╳ ╳ ╳ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  △: 
Indicates it would be dependent on the case . X: Indicates 
document for this item shall not be required for submission.   
2. Draft labels, instructions or packaging:  
(1)  For those who manufacture medical devices, the 
Chinese labels, instructions, or packaging and draft 
color pictures of the actual product appearance.   
(2)  For those who import medical devices, the original 
labels, instructions, or packaging, the draft detailed 
Chinese instructions and draft color pictures of the 
actual product appearance.   
3. Copy of the medical device business permit : 
(1)  Those who manufacture medical devices shall attach a 
copy of the medical device manu factur ing permit . Those 
who import medical devices should attach a copy of the 
medical device dealer permit showing that the business 
category includes “medical device import .” competent 
authority  
16 Samples for 
testing  ╳ ╳ △ △ ╳ ╳ ╳ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted.  △: 
Indicates it would be dependent on the case  X: Indicates 
document for this item shall not be required for submission.   
2. Draft labels, instructions or packaging:  
(1)  For those who manufacture medical devices, the 
Chinese labels, instructions, or packaging and draft 
color pictures of the actual product ap pearance.   
(2)  For those who import medical devices, the original 
labels, instructions, or packaging, the draft detailed 
Chinese instructions and draft color pictures of the 
actual product appearance.   
3. Copy of the medical device business permit : 
(1)  Those who manu facture medical devices shall attach a 
copy of the medical device manufactur ing permit . Those 
who import medical devices should attach a copy of the 
medical device dealer permit showing that the business 
category includes “medical device import .” (2)  For domestic contract manufacturing, both the contract 
party and the contract manufacturer's  medical device 
business permits  shall be submitted.   
4. Manufacture and free sale certificate of the country of origin : 
(1)  This document shall record the following particulars:  
① Name and specifications and/or model number of 
the medical device.   
② Manufacturer ’s name, address, manufacturing 
status, and actual status for domestic sale as 
approved in that country.   
(2)  This document may be replaced by a document issued 
by other authorities or another document in accordance 
with the following provisions:  
① If the medical  device is not regulated by the highest 
health authority in manufacturer ’s country, this 
document may be issued by the local health agency 
or an organization approved by the central 
competent authority of the Republic of China 
(Taiwan).   
② If th e medical device is commissioned to be 
manufactured, this document may be issued by the 
highest health authority in the country where the 
contract party or the contract manufacturer is 
located.   (2)  For domestic contract manufacturing, both the contract 
party and the contract manufacturer's  medical device 
business permits shall be submitted.   
4. Manufacture and free sale certificate of the country of origin:  
(1)  This document shall record the following parti culars:  
① Name and specifications and/or model number of 
the medical device.   
② Manufacturer ’s name, address, manufacturing 
status, and actual status for domestic sale as 
approved in that country.  
(2)  This document may be replaced by a document issued 
by other authorities or another document in accordance 
with the following provisions:  
① If the medical device is not regulated by the highest 
health authority in manufacturer ’s country, this 
document may be issued by the local health agency 
or an organization approve d by the central 
competent authority of the Republic of China 
(Taiwan).  
② If the medical device is commissioned to be 
manufactured, this document may be issued by the 
highest health authority in the country where the 
contract party or the contract manufactu rer is 
located.  ③ If the medical device involves contract 
manufacturing and it is not sold in the country 
where the contract manufacturer is located, this 
document may be replaced by a free sale certificate 
issued by the highest health authority in the 
country where the contract party is located, and a 
manufacture certificate issued by the government 
of the country where the contract manufacturer is 
located.  
④ This document may be replaced by a manufacture 
certificate issued by the government of 
manufacturer ’s country and a free sale certificate 
issued by the highest health authority of  the United 
States of America or of a European Union Member 
State.   
⑤ If the medical device is a world ’s first product with 
no predicate, a report from the central competent 
authority after conducting an on -site inspection of 
the foreign medical device manuf acturer and a 
report of medical device clinical trials carried out 
in the Republic of China (Taiwan) shall be 
submitted for the exemption from submitting the 
manufacture and free sale certificate of the country 
of origin.   ③ If the medical device involves contract 
manufacturing and it is not sold in the country 
where the contract manufacturer is located, this 
document may be replaced by a free sale certificate 
issued by the highest health authority in the 
coun try where the contract party is located, and a 
manufacture certificate issued by the government 
of the country where the contract manufacturer is 
located.  
④ This document may be replaced by a manufacture 
certificate issued by the government of the 
manufactur er’s country and a free sale certificate 
issued by the highest health authority of the United 
States of America or of a European Union Member 
State.  
⑤ If the medical device is a world ’s first product with 
no predicate, a report from the central competent 
authority after conducting an on -site inspection of 
the foreign medical device manufacturer and a 
report of medical device clinical trials carried out 
in the Republic of China (Taiwan) shall be 
submitted for the exemption from submitting the 
manufacture and free sale certificate of the country 
of origin.  (3)  This document shall remain valid for two years from the 
date of issuance, and shall be notarized by the Republic 
of China ’s (Taiwan ’s) overseas embassy or consulate, 
representative office, other official office stationed in 
the region, or overseas organization authorized by the 
Ministry of Foreign Affairs (hereafter referred to as the 
ROC overseas representative office). If the certification 
document is not issued in English, a Chinese or English 
translation shall be submitted at the same time and the 
translation shall be notarized. Howev er, those issued by 
the highest health authority of a country that has 
established technical cooperation agreement with the 
Republic of China (Taiwan) for the premarket review of 
medical devices or those recognized by the central 
competent authority are ex empt from notarization.   
5. Foreign original manufacturer authorization letter:  
(1)  This document shall record the following particulars:  
① The original manufacturer authorizes an agent in 
the Republic of China (Taiwan) to apply for 
registration and market approval  and agrees to 
coordinate with the agent in the Republic of China 
(Taiwan) to comply with relevant medical device 
regulatory requirements.   
② It specifies the name and address of medical device 
firm commissioned or authorized to register, as (3)  This document shall remain valid for two years from the 
date of issuance, and shall be notarized by Republic of 
China ’s (Taiwan ’s) overseas embassy or consulate, 
representative office, other official office stationed in 
the region, or overseas organization authorized by the 
Ministry of Foreign Affairs (hereafter referred to as the 
ROC overseas representative office). If the certification 
document is not issued in English, a Chinese or English 
translation shal l be submitted at the same time and the 
translation shall be notarized. However, those issued by 
the highest health authority of a country that has 
established technical cooperation agreement with the 
Republic of China (Taiwan) for the premarket review of 
medical devices or those recognized by the central 
competent authority are exempt from notarization.   
5. Foreign original manufacturer authorization letter : 
(1)  This document shall record the following particulars:  
① The original manufacturer authorizes an agent in 
the Republic of China (Taiwan) to apply for 
registration and market approval and agrees to 
coordinate with the agent in the Republic of China 
(Taiwan) to comply with relevant medical device 
regulatory requir ements.  
② It specifies the name and address of medical device 
firm commissioned or authorized to register, as well as the name  and specifications and/or model 
number of medical device.   
(2)  This document may be replaced by other documents in 
accordance with the following provisions:  
① A certification document for authorized agent 
issued by the headquarter company of the imported 
medica l devices that authorizes the agent in the 
Republic of China (Taiwan) to apply for 
registration and market approval. Its contents 
explicitly state the name and address of 
manufacturer and specify the name and address of 
medical device firm commissioned or authorized 
to register, as well as the name and specifications 
and/or model number of medical device.   
② The original manufacturer of imported medical 
devices issues a certification document stating its 
foreign agent, and then the foreign agent issues a 
certification document for authorized agent, which 
authorizes the agent in the Republic of China 
(Taiwan) to apply for registration and market 
approval and explicitly states the name and address 
of medical device firm commissioned or 
authorized to register, as  well as the name and 
specifications and/or model number of medical 
device.   well as the name and specifications and/or model 
number of medical device.  
(2)  This document may be replaced by other documents in 
accordance with the  following provisions:  
① A certification document for authorized agent 
issued by the headquarter company of the imported 
medical devices that authorizes the agent in the 
Republic of China (Taiwan) to apply for 
registration and market approval. Its contents 
explicitly state the name and address of   
manufacturer and specify the name and address of  
medical device firm commissioned or authorized 
to register, as well as the name and specifications 
and/or model number of medical device.  
② The original manufacturer of imported medical 
devices issues a certification document stating its 
foreign agent, and then the foreign agent issues a 
certification document for authorized agent, which 
authorizes the agent in the Republic of China 
(Taiwan) to apply for registration a nd market 
approval and explicitly states the name and address 
of medical device firm commissioned or 
authorized to register, as well as the name and 
specifications and/or model number of medical 
device.  (3)  This document shall remain valid for one year from the 
date of issuance. If it is not issued in English, a Chinese 
or English translation shall also be submitted at the same 
time.   
6. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations:  
(1)  This document refers to the certification document 
issued by the central competent authority stating that the 
medical device manufac turer conforms to the Medical 
Device Quality Management System Regulations.   
(2)  For medical devices that were originally regulated as 
pharmaceuticals and within three years from the date of 
announcing the regulatory change to medical devices, 
this document ma y be replaced by a copy of the 
certification document showing conformance to the 
Good Manufacturing Practices for Pharmaceuticals.   
7. Test specifications and methods of preclinical testing and 
quality control conducted by the original manufacturer, the 
origi nal test records, and the test reports:  
(1)  This document shall include information on safety and 
performance testing that has been conducted to ensure 
the claimed efficacy, structure, materials, design, and 
quality of the product.   (3)  This document shall remain valid for one year from t he 
date of issuance. If it is not issued in English, a Chinese 
or English translation shall also be submitted at the same 
time.  
6. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations:  
(1)  This document refers to the certification document 
issued by the central competent authority stating that the 
medical device manufacturer conforms to the Medical 
Device Quality Management System Regulations.   
(2)  For medical devices that were originally regulated a s 
pharmaceuticals and within three years from the date of 
announcing the regulatory change to medical devices, 
this document may be replaced by a copy of the 
certification document showing conformance to the 
Good Manufacturing Practices for Pharmaceuticals .  
7. Test specifications and methods of preclinical testing and 
quality control conducted by the original manufacturer, the 
original test records, and the test reports:  
(1)  This document shall include information on safety and 
performance testing that has been c onducted to ensure 
the claimed efficacy, structure, materials, design, and 
quality of the product.   (2)  For Class 2 medical devices  with predicate device(s) 
that have been approved for marketing by the central 
competent authority, this document may be replaced by 
one of the following documents:  
① Marketing approval certification document issued 
by the government of a country that has established 
technical cooperation agreement with the Republic 
of China (Taiwan) for the premarket review of 
medical devices, as well as Essential Principles 
(EP) of Safety and Performance of Medical 
Devices and Summary Technical Documentation 
(STED).   
② Affidavit of preclinical testing conformity for  
medical device that is a product announced by the 
central competent authority whose manufacturer 
has a predicate device of the same classification 
and approved for marketing by the centra l 
competent authority.   
(3)  For Class 2 medical devices in Appendix 3,  if the 
applicant has obtained the license  showing that the  same 
medical device manufacturer has manufactured a 
predicate device of the same item  and the license is still 
within the validity period, this document m ay be 
replaced by the Class 2 medical device product 
comparison and preclinical test data conformity (2)  For Class 2 medical devices with predicate device(s) 
that have been approved for marketing by the central 
competent authority, this document may be replaced  by 
one of the following documents:  
① Marketing approval certification document issued 
by the government of a country that has established 
technical  cooperation agreement with the Republic 
of China (Taiwan) for the premarket review of 
medical devices, as well as Essential Principles 
(EP) of Safety and Performance of Medical 
Devices and Summary Technical Documentation 
(STED).  
② Affidavit of preclinical t esting conformity for  
medical device that is a product announced by the 
central competent authority whose manufacturer 
has a predicate device of the same classification 
and approved for marketing by the central 
competent authority.  
(3)  For Class 2 medical de vices in Appendix 3, if the same 
manufacturer  has a predicate device approved for 
marketing by the central competent authority that has 
the same product classification and its license is still 
within the validity period, this document may be 
replaced by th e Class 2 medical device product statement,  with the exception of medical devices 
containing medicine.  
(4)  For medical devices that require testing as announced by 
the central competent authority, two copies of this 
document shall be submitted.  
(5)  Commissioned laboratories that conduct the 
biocompatibility, electrical safety, and electromagnetic 
compatibility (EMC) testing shall conform to any of the 
following requirements:  
① Conform to the pr ovisions of ISO/IEC 17025.   
② Conform to the provisions of Good Laboratory 
Practice for Nonclinical Laboratory Studies (GLP).   
8. Documents relating to product structures, materials, 
specifications, functions, intended uses, and drawings: For 
instrument product s, the operation manual and maintenance 
manual that cover these documents may replace them.   
9. Clinical evidence information : 
(1)  This document includes:  
① Academic and theoretical bases, relevant research 
reports and data.   
② Clinical evaluation report or clinical trial report.   
(2)  The central competent authority shall determine or 
announce whether or not the medical device applying 
for registration and market approval requires clinical 
trials in the Republic of China (Taiwan) by considering comparison and preclinical test data conformity 
statement.   
(4)  For medical devices that require testing as announced by 
the central competent authority, two copies of this 
document shall be submitted.  
(5)  Commissioned laboratories  that conduct the 
biocompatibility, electrical safety, and electromagnetic 
compatibility (EMC) testing shall conform to any of the 
following requirements:  
① Conform to the provisions of ISO/IEC 17025.  
② Conform to the provisions of Good Laboratory 
Practice fo r Nonclinical Laboratory Studies (GLP).  
8. Documents relating to product structures, materials, 
specifications, functions, intended uses, and drawings: For 
instrument products, the operation manual and maintenance 
manual that cover these documents may replac e them.   
9. Clinical evidence information:  
(1)  This document includes:  
① Academic and theoretical bases, relevant research 
reports and data.  
② Clinical evaluation report or clinical trial report.  
(2)  The central competent authority shall determine or 
announce whether or not the medical device applying 
for registration and market approval requires clinical 
trials in the Republic of China (Taiwan) by considering the medical device product item, individual case, and 
data submitted by applicant.   
(3)  For medical devices with predicate device(s) that have 
been approved for marketing by the central competent 
authority, unless it is necessary to verify their safety and 
effectiveness with clinical ev idence, this document may 
be exempt from submission.   
(4)  For Class 2 medical devices without predicate device, 
unless otherwise specified, the clinical trial report may 
be replaced by supporting data that meets all the 
following conditions:  
① There are no ethni c differences in the expected 
effectiveness of this product.   
② There are no serious adverse reports related to the 
claimed intended use or indication for such type of 
product in foreign countries, and the product has 
not been required to be removed from the  market.   
③ Preclinical data (including trial) may be used to 
demonstrate that the differences between the 
product and domestic products that have been 
approved for marketing will not affect the 
product ’s safety and effectiveness; or marketing 
approval certification documents of the United 
States of America and the European Union may be 
provided and the indication under application does the medical device product item, individua l case, and 
data submitted by applicant.  
(3)  For medical devices with predicate device(s) that have 
been approved for marketing by the central competent 
authority, unless it is necessary to verify their safety and 
effectiveness with clinical evidence, this do cument may 
be exempt from submission.  
(4)  For Class 2 medical devices without predicate device, 
unless otherwise specified, the clinical trial report may 
be replaced by supporting data that meets all the 
following conditions:  
① There are no ethnic differences i n the expected 
effectiveness of this product.  
② There are no serious adverse reports related to the 
claimed intended use or indication for such type of 
product in foreign countries, and the product has 
not been required to be removed from the market.  
③ Precl inical data (including trial) may be used to 
demonstrate that the differences between the 
product and domestic products that have been 
approved for marketing will not affect the 
product ’s safety and effectiveness; or marketing 
approval certification documents of the United 
States of America and the European Union may be 
provided and the indication under application does not exceed the scope approved by the United States 
of America and the  European Union.   
10. Radiation safety information for equipment generating 
ionizing radiation: For medical devices generating ionizing 
radiation, this document shall be submitted.   
11. Essential Principles (EP) of Safety and Performance of 
Medical Devices and Sum mary Technical Documentation 
(STED):  
(1)  The format of this document shall follow the 
announcement  of the central competent authority.   
(2)  For Class 2 medical devices under application with 
the circumstances in Paragraph (2) ① of Section 7, 
this document shall be  submitted.   
12. Manufacturer's letter explaining that the product is the same 
product with different product names: It shall explain that the 
product for which a new application has been made and the 
originally approved product are identical products, and 
indicate clearly the medical device license number that was 
originally approved.  
13. Other documents and information designated by the central 
competent authority:  
(1)  For medical devices using bovine or ovine/hircine 
tissues, an explanation of animal raw material  source 
control procedures and proof of raw material source 
from the original manufacturer shall be submitted in not exceed the scope approved by the United States 
of America and the  European Union.  
10. Radiation safety information for equipment generating 
ionizing radiation: For medical devices generating ionizing 
radiation, this document shall be submitted.   
11. Essential Principles (EP) of Safety and Performance of 
Medical Devices and Sum mary Technical Documentation 
(STED):  
(1)  The format of this document shall follow the 
announcement of the central competent authority.   
(2)  For Class 2 medical devices under application with 
the circumstances in Paragraph (2) ① of Section 7, 
this document shall be  submitted.   
12. Manufacturer ’s letter explaining that the product is the same 
product with different product names: It shall explain that the 
product for which a new application has been made and the 
originally approved product are identical products, and 
indicate clearly the medical device license number that was 
originally approved.  
13. Other documents and information designated by the central 
competent authority:  
(1)  For medical devices using bovine or ovine/hircine 
tissues, an explanation of animal raw material source 
control procedures and proof of raw material source 
from the original manufacturer shall be submitted in order to verify that the processes associated with the 
medical device and the ultimate finished product do 
not use any bovine or ovine/hircine product from the 
bovine spongiform encephalopathy (BSE) epidemic 
areas announced by the Council of Agriculture, 
Executive Yuan, and have not been contaminated by 
BSE pathogens. However, for applications 
conforming to the announcement from the central 
compe tent authority regarding the exemption from 
submitting the aforementioned documentation after 
considering the international regulatory guidelines for 
controlling bovine or ovine/hircine tissues in 
accordance with the risk of contamination of the 
tissues by  BSE pathogen, this provision shall not 
apply.   
(2)  If the product name bears a trademark, relevant 
information related to trademark registration shall be 
submitted. If the product name bears the name or 
trademark of another medical device firm, a consent 
letter issued by the firm shall be submitted . 
(3)  In line with the Consolidated List of Commodities 
Subject to Import Restriction and Commodities 
Assisted by Customs for Import Examination 
announced by the Bureau of Foreign Trade of the 
Ministry of Economic Affairs, medical devices order to verify that the processes associated w ith the 
medical device and the ultimate finished product do 
not use any bovine or ovine/hircine product from the 
bovine spongiform encephalopathy (BSE) epidemic 
areas announced by the Council of Agriculture, 
Executive Yuan, and have not been contaminated b y 
BSE pathogens. However, for applications 
conforming to the announcement from the central 
competent authority regarding the exemption from 
submitting the aforementioned documentation after 
considering the international regulatory guidelines for 
controllin g bovine or ovine/hircine tissues in 
accordance with the risk of contamination of the 
tissues by BSE pathogen, this provision shall not 
apply.   
(2)  If the product name bears a trademark, relevant 
information related to trademark registration shall be 
submitted . If the product name bears the name or 
trademark of another medical device firm, a consent 
letter issued by the firm shall be submitted .  
(3)  In line with the Consolidated List of Commodities 
Subject to Import Restriction and Commodities 
Assisted by Customs f or Import Examination 
announced by the Bureau of Foreign Trade of the 
Ministry of Economic Affairs, medical devices imported from China sha ll first obtain permit for 
import from the Bureau of Foreign Trade of the 
Ministry of Economic Affairs before applying for 
registration and market approval from the central 
competent authority.   
(4)  For medical devices exclusively  for export, the 
instructions  for use , function, working principle, and 
explanation of product composition (or ingredients) 
shall be submitted, and the content s of which shall be 
sufficient to determine that th is product meets the 
identification of the product item under application.  
(5) If the name, the label, instructions or packaging of 
the product bears a proper noun for 
performance/specification of a specific country or 
international organization standards, supporting 
documents issued by the country or the region, a 
third -party validat ion agency, or the international 
organization should be attached.   
14. Samples for testing : For items announced in Paragraph 2 
of Article 3,  the applicant shall  follow the testing notice, 
pay the testing fee by the designated deadline, and submit 
sufficient samples for testing to conduct testing 
procedures.  imported from China shall first obtain permit for 
import from the Bureau of Foreign Trade of the 
Ministry of Economic Affairs before applyin g for 
registration and market approval from the central 
competent authority.   
(4)  For medical devices exclusively for export , the 
instructions  for use , function, working principle,  and 
explanation of product composition (or ingredients) 
shall be submitted, and the content s of which shall be 
sufficient to determine that th is product meets the 
identification of the product item under application.   
14. Samples for testing: The applicant shall follow the testing 
notice, pay the testing fee by the  designated deadline, and 
submit sufficient samples for testing to conduct testing 
procedures.  Comparison Table of Original and Amended Provisions in Appendix 3 of Article 6  
Amended title  Original title  Description  
Appendix 3: “Applicable Product Items for Class 2 Medical 
Device Product Comparison and Preclinical Test Data 
Conformity Statement ” mentioned in Section 7 of the 
Instructions in Appendix 2  Appendix 3: Applicable Product Items for Class 2 Medical 
Device Product Comparison and Preclinical Test Data 
Conformity Statement  Slight revision of 
the title of 
Appendix 3 for 
clarity  
Amended provisions  Original title  Description  
 
 Item Number  Name  
1 A.1020  Acid phosphatase (total or 
prostatic) test system  
2 A.1025  Adrenocorticotropic hormone 
(ACTH) test system  
3 A.1035  Albumin test system  
4 A.1050  Alkaline phosphatase or 
isoenzymes test system  
5 A.1070  Amylase test system  
6 A.1110  Bilirubin (total or direct) test 
system  
7 A.1150  Calibrator  
8 A.1155  Human chorionic gonadotropin 
(HCG) test system   
 Item Number  Name  
1 A.1020  Acid phosphatase (total or 
prostatic) test system  
2 A.1025  Adrenocorticotropic hormone 
(ACTH) test system  
3 A.1035  Albumin test system  
4 A.1050  Alkaline phosphatase or 
isoenzyme s test system  
5 A.1070  Amylase test system  
6 A.1110  Bilirubin (total or direct) test 
system  
7 A.1150  Calibrator  
8 A.1345  Glucose test system  Added applicable 
product items.  9 A.1215  Creatine phosphokinase/creatine 
kinase or isoenzymes test system  
10 A.1345  Glucose test system  
11 A.1660  Quality control material (assayed 
and unassayed)  
12 A.1675  Blood specimen collection device  
13 B.5400  Coagulation instrument  
14 B.5425  Multipurpose system for in vitro 
coagulation studies  
15 B.7470  Glycosylated hemoglobin assay  
16 B.8625  Hematology quality control 
mixture  
17 C.0002  Dengue virus serological reagents  
18 C.2410  Culture medium for pathogenic 
Neisseria spp  
19 C.3305  Herpes simplex virus serological 
reagents  
20 C.3390  Neisseria spp. Direct serological 
test reagents  
21 C.3860  Trichomonas vaginalis nucleic acid 
assay  9 A.1660  Quality control material (assayed 
and unassayed)  
10 C.5510  Immunoglobulins A, G, M, D, and 
E immunological test system  
11 D.5630  Nebulizer  
12 E.1130  Noninvasive blood pressure 
measurement system  
13 E.2340  Electrocardiograph  
14 E.2700  Oximeter  
15 F.3200  Resin tooth bonding agent  
16 F.3590  Preformed plastic denture tooth  
17 F.3660  Impression material  
18 F.4850  Ultrasonic scaler  
19 F.6070  Ultraviolet activator for   
polymerization  
20 F.6660  Porcelain powder for clinical use  
21 H.5470  Ureteral dilator  
22 I.0006  Medical protective clothing  22 C.5100  Antinuclear antibody 
immunological test system  
23 C.5270  C-reactive protein immunological 
test system  
24 C.5510  Immunoglobulins A, G, M, D, and 
E immunological test system  
25 C.5750  Radioallergosorbent  (RAST) 
immunological test system  
26 C.5775  Rheumatoid factor immunological 
test system  
27 D.5630  Nebulizer  
28 D.5710  Electrically powered oxygen tent  
29 D.5730  Tracheal tube  
30 D.5800  Tracheostomy tube and tube cuff  
31 D.5915  Manual emergency ventilator  
32 E.0005  Percutaneous transluminal 
coronary angioplasty (PTCA)   
catheter  
33 E.1130  Noninvasive blood pressure 23 I.4370  Surgical drape and drape 
accessories  
24 I.4495  Stainless steel suture  
25 I.4580  Surgical lamp  
26 J.2800  Sterilization process indicator  
27 J.2910  Clinical electronic thermometer  
28 J.5440  Intravascular administration set  
29 J.5570  Hypodermic single lumen needle  
30 J.5860  Piston syringe  
31 J.6850  Sterilization wrap  
32 M.5918  Rigid gas permeable contact lens 
care products  
33 M.5928  Soft (hydrophilic) contact lens care 
products  
34 O.5500  Infrared lamp  
 measurement system  
34 E.1200  Diagnostic intravascular catheter  
35 E.1210  Continuous flush catheter  
36 E.1220  Electrode recording  catheter or 
electrode recording probe  
37 E.1280  Steerable catheter  
38 E.1310  Vessel dilator for percutaneous 
catheterization  
39 E.1330  Catheter guide wire  
40 E.1340  Catheter introducer  
41 E.1650  Angiographic injector and syringe  
42 E.2340  Electrocardiograph  
43 E.2360  Electrocardiograph electrode  
44 E.2700  Oximeter  
45 E.2900  Patient transducer and electrode 
cable (including connector)  
46 E.3450  Vascular graft prosthesis  
47 E.4450  Vascular clamp  
48 E.5150  Embolectomy catheter  49 E.5900  Thermal regulati ng system  
50 F.1745  Laser fluorescence caries detection 
device  
51 F.1800  Extraoral source x -ray system  
52 F.1810  Intraoral source x -ray system  
53 F.3060  Gold based alloys and precious 
metal alloys for clinical use  
54 F.3200  Resin tooth bonding agent  
55 F.3275  Dental cement  
56 F.3590  Preformed plastic denture tooth  
57 F.3630  Endosseous dental implant 
abutment  
58 F.3660  Impression material  
59 F.3690  Tooth shade resin material  
60 F.3765  Pit and fissure sealant and 
conditioner  
61 F.3820  Root canal filling resin  
62 F.4760  Bone plate  
63 F.4850  Ultrasonic scaler  
64 F.6070  Ultraviolet activator for 
polymerization  
65 F.6660  Porcelain powder for clinical use  66 G.4250  Ear, nose, and throat electric or 
pneumatic surgical drill  
67 H.1075  Gastroenterology -urology biopsy 
instrument  
68 H.1500  Endoscope and accessories  
69 H.4620  Ureteral stent  
70 H.5010  Biliary catheter and accessories  
71 H.5130  Urological  catheter and accessories  
72 H.5470  Ureteral dilator  
73 H.5540  Blood access device and 
accessories  
74 H.5630  Peritoneal dialysis system and 
accessories  
75 H.5820  Hemodialysis system and 
accessories  
76 H.5980  Gastrointestinal tube and 
accessories  
77 I.0003  Ultrasonic surgical instrument  
78 I.0006  Medical protective clothing  
79 I.4010  Tissue adhesive  
80 I.4014  Nonresorbable gauze/sponge for 
external use  81 I.4018  Hydrophilic wound dressing  
82 I.4020  Occlusive wound/burn dressing  
83 I.4022  Hydrogel wound dressing and burn 
dressing  
84 I.4370  Surgical drape and drape 
accessories  
85 I.4400  Electrosurgical cutting and 
coagulation device and accessories  
86 I.4493  Absorbable poly(glycolide/L -
lactide) surgical suture  
87 I.4495  Stainless steel suture  
88 I.4580  Surgical lamp  
89 I.4780  Power suction pump  
90 I.4810  Laser surgical instrument for use in 
general and plastic surgery and in 
dermatology  
91 I.4830  Absorbable surgical gut suture  
92 I.4840  Absorbable polydioxanone surgical 
suture  
93 I.5000  Nonabsorbable poly (ethylene 
terephthalate) surgical suture  
94 I.5010  Nonabsorbable polypropylene 
surgical suture  95 I.5020  Nonabsorbable polyamide surgical 
suture  
96 I.5030  Natural nonabsorbable silk surgical 
suture  
97 I.5035  Nonabsorbable expanded 
polytetrafluoroethylene surgical 
suture  
98 J.2800  Sterilization process indicator  
99 J.2910  Clinical electronic thermometer  
100 J.5090  Liquid bandage  
101 J.5200  Intravascular catheter  
102 J.5240  Medical adhesive tape and 
adhesive bandage  
103 J.5440  Intravascular administration set  
104 J.5570  Hypodermic single lumen needle  
105 J.5700  Neonatal phototherapy unit  
106 J.5860  Piston syringe  
107 J.5965  Subcutaneous, implanted, 
intravascular infusion port and 
catheter  
108 J.5970  Percutaneous, implanted, long -term 
intravascular catheter  109 J.6850  Sterilization wrap  
110 K.4305  Powered compound cranial drills, 
burrs, trephines, and their  
accessories  
111 K.4310  Powered simple cranial drills, 
burrs, trephines,  and their 
accessories  
112 K.4360  Electric cranial drill motor  
113 K.4370  Pneumatic cranial drill motor  
114 K.4840  Manual rongeur  
115 L.1690  Hysteroscope and accessories  
116 L.1720  Gynecologic laparoscope and 
accessories  
117 L.1730  Laparoscopic insufflator  
118 L.4150  Bipolar endoscopic coagulator -
cutter and accessories  
119 L.6100  Assisted reproduction needles  
120 L.6110  Assisted reproduction catheters  
121 L.6130  Assisted reproduction microtools  122 M.1120  Ophthalmic camera  
123 M.1570  Ophthalmoscope  
124 M.1850  AC-powered slitlamp 
biomicroscope  
125 M.4150  Vitreous aspiration and cutting 
instrument  
126 M.4670  Phacofragmentation system  
127 M.4790  Ophthalmic sponge  
128 M.5918  Rigid gas permeable contact lens 
care products  
129 M.5925  Soft (hydrophilic) contact lens  
130 M.5928  Soft (hydrophilic) contact lens care 
products  
131 N.1100  Arthroscope  
132 N.3027  Polymethylmethacrylate (PMMA) 
bone cement  
133 N.3045  Resorbable calcium salt bone void 
filler device  
134 N.3050  Spinal interlaminal fixation 
orthosis  135 N.3060  Spinal intervertebral body fixation 
orthosis  
136 N.3070  Pedicle screw spinal system  
137 O.0001  Static electric therapy apparatus  
138 O.3860  Powered wheelchair  
139 O.5500  Infrared lamp  
140 P.1570  Diagnostic ultrasonic transducer  
 Comparison Table of Amended and Original Provisions in Appendix 4, Article 13  
Amended provisions  Original provisions  Description  
Appendix 4 : Documents and information that shall be submitted for an 
application of  change, re -issuance , or replacement of medical device 
license  
Item to be  
Changed  
 
 
 
 
 
 
 
 
 
 
 
Documents  
and 
Information to 
be Submitted  Chinese product name  English product name  Labels, Instructions, or Packaging  Ingredients, Materials, Structures, Specifications, or Model number  Effectiveness, Intended Use, or Indication  Name of the Manufacturer  Address of the Manufacturer or Country of  Manufacture  License Holder  Name of the Lice nse Holder  Re-issuance or Replacement of a Lost or Damaged License  Manufacturing license number  Appendix 4: Documents and information that shall be submitted for an 
application of change, re -issuance , or replacement of medical device 
license  
Item to be  
Changed  
 
 
 
 
 
 
 
 
 
 
 
Documents  
and 
Information to 
be Submitted  Chinese product name  English product name  Labels, Instructions, or Packaging  Ingredients, Materials, Structures, Specifications, or Model number  Effectiveness, Intended Use, or Indication  Name of the Manufacturer  Address of the Manufacturer or Country of  Manufacture  License Holder  Name of the License Holder  Re-issuance or Replacement of a Lost or Damaged License  1. As Article 13 
has added the 
manufacturin
g license 
number to be 
one of the 
registration 
particulars of 
medical 
device license 
registration, it 
has been 
added to the 
documents 
and 
information 
that shall be 
submitted for 
an application 
of change of 
medical 
device 1 Application 
form for 
change of 
medical 
device 
license  ○ ○ ○ ○ ○ ○ ○ ○ 
Note 
9 ○ ○ ○ 
2 Application 
form for 
medical 
device 
registration 
and market 
approval  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ △ 
Note 
13 ╳ 
3 Original 
license  ○ ○ ○ ○ ○ ○ ○ ○ ○ △ 
Note 
14 ○ 
4 Copy of the 
originally 
approved 
labels,  
instructions
, or 
packaging 
stamped 
with tally ╳ ╳ ○ △ 
Note 
2 ○ ╳ ╳ ╳ ╳ △ 
Note 
15 ╳ 1 Application 
form for 
change of 
medical 
device 
license  ○ ○ ○ ○ ○ ○ ○ ○ 
Note 
8 ○ ○ 
2 Application 
form for 
medical 
device 
registration 
and market 
approval  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ △ 
Note 
12 
3 Original 
license  ○ ○ ○ ○ ○ ○ ○ ○ ○ △ 
Note 
13 
4 Copy of the 
originally 
approved 
labels, 
instructions
, or 
packaging 
stamped 
with tally ╳ ╳ ○ △ 
Note 
2 ○ ╳ ╳ ╳ ╳ △ 
Note 
14 license.  
2. Change of 
wording of 
Section 2 of 
the 
Instructions.  
3. To be more 
specific, the 
content of 
Note 7 has 
been changed. 
Partial 
content of the 
original Note 
7 has been 
listed in Note 
8 and Note 1 8 
and the serial 
number  has 
been adjusted . impression 
of the 
central 
competent 
authority  
5 Two copies 
of draft 
labels, 
instructions
, or 
packaging  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ △ 
Note 
16 ╳ 
6 Copy of the 
medical 
device 
business 
permit  ╳ ╳ ╳ ╳ ╳ △ 
Note 
5 △ 
Note 
5 ○ 
Note 
10 ○ 
Note 
12 ╳ ╳ 
7 Original of 
the 
manufactur
e and free 
sale 
certificate 
of the 
country of 
origin  ╳ △ 
Note 
1 ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
6 ╳ ╳ ╳ ╳ impression 
of the 
central 
competent 
authority  
5 Two copies 
of draft 
labels, 
instructions
, or 
packaging  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ △ 
Note 
15 
6 Copy of the 
medical 
device 
business 
permit  ╳ ╳ ╳ ╳ ╳ △ 
Note 
5 △ 
Note 
5 ○ 
Note 
9 ○ 
Note 
11 ╳ 
7 Original of 
the 
manufactur
e and free 
sale 
certificate 
of the 
country of 
origin  ╳ △ 
Note 
1 ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
6 ╳ ╳ ╳ 8 Original of 
the foreign 
original 
manufactur
er 
authorizatio
n letter  ╳ ╳ ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
11 ╳ ╳ ╳ 
9 Document 
verifying 
that 
medical 
device 
manufactur
er conforms 
to the 
Medical 
Device 
Quality 
Manageme
nt System 
Regulations  ╳ ╳ ╳ ╳ ╳ ○ ○ ╳ ╳ ╳ ○ 
10 Test 
specificatio
ns and 
methods of ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
7 ╳ ╳ ╳ ╳ 8 Original of 
the foreign 
original 
manufactur
er 
authorizatio
n letter  ╳ ╳ ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
10 ╳ ╳ 
9 Document 
verifying 
that 
medical 
device 
manufactur
er conforms 
to the 
Medical 
Device 
Quality 
Manageme
nt System 
Regulations  ╳ ╳ ╳ ╳ ╳ ○ ○ ╳ ╳ ╳ 
10 Test 
specificatio
ns and 
methods of ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
7 ╳ ╳ ╳ preclinical 
testing and 
quality 
control 
conducted 
by the 
original 
manufactur
er, the 
original test 
records, 
and the test 
reports  Note 
8 
11 Documents 
relating to 
product 
structures, 
materials, 
specificatio
ns, 
functions, 
intended 
uses, and 
drawings  ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
7 
Note 
8 ╳ ╳ ╳ ╳ preclinical 
testing and 
quality 
control 
conducted 
by the 
original 
manufactur
er, the 
original test 
records, 
and the test 
reports  
11 Documents 
relating to 
product 
structures, 
materials, 
specificatio
ns, 
functions, 
intended 
uses, and 
drawings  ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note 
7 ╳ ╳ ╳ 12 Clinical 
evidence 
information  ╳ ╳ ╳ △ 
Note 
3 △ ╳ ╳ ╳ ╳ ╳ ╳ 
13 Radiation 
safety 
information 
for 
equipment 
generating 
ionizing 
radiation  ╳ ╳ ╳ △ 
Note 
3 ╳ ╳ ╳ ╳ ╳ ╳ ╳ 
14 Original of 
the 
manufactur
er’s letter 
that 
explains the 
change  ╳ ○ ○ △ 
Note 
3 ○ ○ ○ ╳ ╳ ╳ ╳ 
15 Compariso
n table of 
changed 
and 
originally 
approved 
content  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ ╳ ╳ 12 Clinical 
evidence 
information  ╳ ╳ ╳ △ 
Note 
3 △ ╳ ╳ ╳ ╳ ╳ 
13 Radiation 
safety 
information 
for 
equipment 
generating 
ionizing 
radiation  ╳ ╳ ╳ △ 
Note 
3 ╳ ╳ ╳ ╳ ╳ ╳ 
14 Original of 
the 
manufactur
er’s letter 
that 
explains the 
change  ╳ ○ ○ △ 
Note 
3 ○ ○ ○ ╳ ╳ ╳ 
15 Compariso
n table of 
changed 
and 
originally 
approved 
content  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ ╳ 16 Transfer 
statement 
co-signed 
by the 
transferor 
and 
transferee  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ ╳ 
17 Statement 
from the 
medical 
device firm 
receiving 
the 
transferred 
license 
(transferee) 
affirming 
the 
responsibili
ty for the 
transferred 
medical 
device  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ ╳ 16 Transfer 
statement 
co-signed 
by the 
transferor 
and 
transferee  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
17 Statement 
from the 
medical 
device firm 
receiving 
the 
transferred 
license 
(transferee) 
affirming 
the 
responsibili
ty for the 
transferred 
medical 
device  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 18 Statement  
from the 
medical 
device firm 
after name 
change 
affirming 
the 
responsibili
ty for every 
item on the 
changed 
license  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
19 Statement 
claiming 
that change 
in the name 
of a 
medical 
device firm 
holding the 
medical 
device 
license  
does not ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 18 Statement  
from the 
medical 
device firm 
after name 
change 
affirming 
the 
responsibili
ty for every 
item on the 
changed 
license  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ 
19 Statement 
claiming 
that change 
in the name 
of a 
medical 
device firm 
holding the 
medical 
device 
license  
does not ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳  
Instructions:  
I. ○: Indicates document for this item shall be submitted. △: 
Indicates it would be dependent on the case. ╳: Indicates 
document for this item shall not be required for submission.  
II. Please refer to the instructions of Appendix 2 for relevant 
regulations on: draft labels, instructions, or packaging; copy of the 
medical device business permit ; manufacture and free sale 
certificate of the country of origin; forei gn original manufacturer involve 
transfer of 
rights  
20 Other 
documents 
and 
information 
designated 
by the 
central 
competent 
authority  △ △ △ △ △ △ △ △ △ △ 
Note 
17 △ 
 
21 Samples 
for testing  ╳ ╳ ╳ △ 
Note 
18 ╳ ╳ △ 
Note 
18 ╳ ╳ ╳ ╳  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Instructions:  
I. ○: Indicates document for this item shall be submitted. △: 
Indicates it would be dependent on the case. ╳: Indicates 
document for this item shall not be required for submission.  
II. Please refer to the instructions of Appendix 2 for relevant 
regulations on: draft labels, instructions, or packaging; copy of the 
medical device business permit ; manufacture and free sale 
certificate of the country of origin; foreign original manufacturer involve 
transfer of 
rights  
20 Other 
documents 
and 
information 
designated 
by the 
central 
competent 
authority  △ △ △ △ △ △ △ △ △ △ 
Note 
16 
21 Samples 
for testing  ╳ ╳ ╳ △ ╳ ╳ △ ╳ ╳ ╳ authorization letter; document verifying that medical device 
manufacturer conforms to the Medical Device Quality 
Management System Regulations; test specifications and methods 
of preclinical testing and quality control conducted by  the original 
manufacturer; original test records and test reports; documents 
relating to product structure, materials, specifications, functions, 
intended uses, and drawings; clinical evidence  information; 
radiation safety information for equipment genera ting ionizing 
radiation; other documents designated by the central competent 
authority; and samples for testing.  
 
Notes:  
1. The manufacture and free sale certificate of the country of origin 
shall be able to indicate that the changed product and the original ly 
approved product are the same. For domestically manufactured 
medical devices, it is exempt from submission.  
2. This is exempt from submission if the change of specifications does 
not involve changing the originally approved labels, instructions, or 
packagi ng.  
3. This is exempt from submission for deletion of specifications.  
4. For domestically manufactured medical devices, this is exempt 
from submission. For deletion of specifications, this is exempt from 
submission.  
5. For domestically manufactured medical device s, a copy of new 
firm's medical device manufacturing permit shall be submitted. For authorization letter; document verifying that medical device 
manufacturer conforms to the Medical Device Quality 
Management System Regulations; test specifications and methods 
of preclinical testing and quality control conducted by the original 
manufacture r; original test records and test reports; documents 
relating to product structure, materials, specifications, functions, 
intended uses, and drawings; clinical evidence  information; 
radiation safety information for equipment generating ionizing 
radiation; other documents designated by the central competent 
authority; and samples for testing.  
 
Notes:  
1. The manufacture and free sale certificate of the country of origin 
shall be able to indicate that the changed product and the originally 
approved product are the same. For domestically manufactured 
medical devices, it is exempt from submission.  
2. This is exempt from submission if the change of specifications does 
not involve changing the originally approved labels, instructions, or 
packaging.  
3. This is exempt from  submission for deletion of specifications.  
4. For domestically manufactured medical devices, this is exempt 
from submission. For deletion of specifications, this is exempt from 
submission.  
5. For domestically manufactured medical devices, a copy of new 
firm's medical device manufacturing permit shall be submitted. For imported medical devices, this is exempt from submission.  
6. For domestically manufactured medical devices, this is exempt 
from submission. If the change of manufacturer's add ress was due 
to house numbering system change, this document may be exempt 
but certificate document issued by a government agency shall be 
submitted; in the case of imported medical devices, it shall be 
notarized by ROC overseas representative office.  
7. If the application for change involves a Class 3 in vitro diagnostic 
medical device , this information shall be attached. For applications 
for change of other products,  the central competent authority may, 
when necessary, order  submission of this document.  
8. For medical devices that require testing as announced by the central 
competent authority, two copies of this document shall be 
submitted.  
9. The change of license holder shall be applied jointly by the 
transferor and transferee.  
10. This refers to a copy of the transferee's medical device business 
permit.  
11. The foreign original manufacturer authorization letter shall explain 
in detail about termination of the rights of the transferor, and 
bestowing of such rights to the transferee, and shall state the 
product name  and the names and addresses of transferor and 
transferee. For domestically manufactured medical devices, it is 
exempt from submission.  
12. This refers to a copy of the transferee's medical device business imported medical devices, this is exempt from submission.  
6. For domestically manufactured medical devices, this is exempt 
from submission. If the change of manufacturer's address was due 
to house nu mbering system change, this document may be exempt 
but certificate document issued by a government agency shall be 
submitted; in the case of imported medical devices, it shall be 
notarized by ROC overseas representative office.  
7. When necessary, the central competent authority may order 
submission of technical documents relating to product structures, 
materials, specifications, functions, intended uses, drawings, and 
technical documents of preclinical testing and quality control test 
data of the original manu facturer. If the application for change 
involves a Class 3 in vitro diagnostic medical device, this 
information shall be submitted. For medical devices that require 
testing as announced by the central competent authority, two 
document copies shall be submi tted. The applicant shall follow the 
testing notice, pay the testing fee by the designated deadline, and 
submit sufficient samples for testing to conduct testing procedures.  
8. The change of license holder shall be applied jointly by the 
transferor and trans feree.  
9. This refers to a copy of the transferee's medical device business 
permit.  
10. The foreign original manufacturer authorization letter shall explain 
in detail about termination of the rights of the transferor, and 
bestowing of such rights to the transfe ree, and shall state the permit after name change.  
13. This document shall be submitted when applying for re -issuance or 
replacement of a lost or damaged license. It is exempt from 
submission when applying for re -issuance or replacement of lost or 
damaged labels, instructions, or packaging.  
14. This is exempt fro m submission when applying for re -issuance of a 
lost license.  
15. This document shall be submitted when applying for replacement 
of damaged labels, instructions, or packaging. It is exempt from 
submission when applying for re -issuance or replacement of a lost 
or damaged license and re -issuance of lost labels, instructions, or 
packaging.  
16. This document shall be attached when applying for re -issuance or 
replacement of lost or damaged labels, instructions, or packaging. 
It is exempt from submission when applying f or re -issuance or 
replacement of a lost or damaged license.  
17. When applying for re -issuance of a lost license, a statement 
declaring that the original license has indeed been lost shall be 
submitted. When applying for re -issuance or replacement of lost or 
damaged labels, instructions, or packaging, a statement declaring 
that the original labels, instructions, or packaging has indeed been 
lost shall be submitted.  
18. The applicant shall follow the testing notice, pay the testing fee by 
the designated deadline, an d submit sufficient samples for testing 
to conduct testing procedures.  product name and the names and addresses of transferor and 
transferee. For domestically manufactured medical devices, it is 
exempt from submission.  
11. This refers to a copy of the transferee's medical device business 
permit after nam e change.  
12. This document shall be submitted when applying for re -issuance or 
replacement of a lost or damaged license. It is exempt from 
submission when applying for re -issuance or replacement of lost or 
damaged labels, instructions, or packaging.  
13. This is exempt from submission when applying for re -issuance of a 
lost license.  
14. This document shall be submitted when applying for replacement 
of damaged labels, instructions, or packaging. It is exempt from 
submission when applying for re -issuance or replacement of a lost 
or damaged license and re -issuance of lost labels, instructions, or 
packaging.  
15. This document shall be attached when applying for re -issuance or 
replacement of lost or damaged labels, instructions, or packaging. 
It is exempt from submission when applying for re -issuance or 
replacement of a lost or damaged license.  
16. When applying for re -issuance of a lost license, a statement 
declaring that the original license has indeed been lost shall be 
submitted. When applying for re -issuance or replacement of  lost or 
damaged labels, instructions, or packaging, a statement declaring 
that the original labels, instructions, or packaging has indeed been lost shall be submitted.  
 Comparison Table of Original and Amended Provisions in Appendix 5 of Article 20  
Amended provisions  Original provisions  Description  
Appendix 5: Documents and information that shall be uploaded for 
an application for a listing to manufacture or import Class 1 medical 
device s 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted. △: 
Indicates it would be dependent on the case.   
Item Upload 
1 Copy of the medical device business 
permit  ○ 
2 Document verifying that medical device 
manufacturer conforms to the Medical 
Device Quality Management System 
Regulations  △ 
3 Instructions of product from the original 
manufacturer  △ 
4 Test specifications and methods for 
preclinical test ing and the test reports  △ 
5 Other documents and information 
designated by the central competent 
authority  △  1. Newly added 
appendix . 
2. This appendix is 
added to list 
documents and 
information that 
shall be uploaded 
for an application 
for a listing in 
accordance with 
the amended 
Article 20.  2. Copy of the medical device business permit:  
(1) Those who manufacture medical devices shall upload a 
copy of the medical device manufacturing permit. Those 
who import medical devices shall upload a copy o f the 
medical device dealer permit showing that the business 
category includes “medical device import ”. 
(2) For domestic contract manufacturing, both the contract 
party and the contract manufacturer's medical dev ice 
business permits shall be uploaded.  
3. Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management System 
Regulations: This document refers t o a copy of the certification 
document issued by the central competent a uthority stating that 
the medical device manufacturer conforms to the Medical 
Device Quality Management System Regulations.  However, 
this shall  not be required for items that, as product items 
announced by the central competent authority, do not need to 
obtain manufacturing license.  
4. Instructions of product from the original manufacturer: They 
shall include the instructions for use, function, working 
principle, explanation of product composition (or ingredients), 
and the contents of which shall be sufficient  to determine that 
the medical product meets the identification of Class 1 
classification. For items designated by the listing system, this document should be uploaded.  
5. Test specifications and methods of preclinical testing and the 
test reports: These docu ments shall be uploaded if the product 
performance/specifications have been described in the 
identification provisions of Class 1 medical device product 
items or announced by the central competent authority 
pursuant to Article 30 of the Act.  
6. Other documents and information designated by the central 
competent authority : 
(1) If the product name bears a trademark, relevant 
information related to trademark registration shall be 
uploaded. If the product name bears the name or 
trademark of another firm, a con sent letter issued by the 
firm shall be uploaded.  
(2) In line with the Consolidated List of Commodities Subject 
to Import Restriction and Commodities Assisted by 
Customs for Import Examination announced by the 
Bureau of Foreign Trade of the Ministry of Economi c 
Affairs, medical devices imported from China shall first 
obtain permit for import from the Bureau of Foreign Trade 
of the Ministry of Economic Affairs before applying for a 
listing from the central competent authority.  
(3) If the name of the product bears a proper noun for 
performance/specification of a specific country or international organization standards, supporting 
documents issued by the country or the region, a third -
party validation agency, or the international organization 
should be uploaded.  
 Amended Provisions in “Regulations Governing Issuance of Medical 
Device License, Listing and Annual Declaration ” 
 
Article 3  
Applicants who apply for a license issued by the registration and market approval to 
manufacture or import medical devices shall submit documents and information in 
accordance with the provisions of Articles 5 and 6 and pay the fee to the central competent  
authority for submission.  
 
To apply for the registration and market approval referred to in the preceding paragraph for 
items announced by the central competent authority, applicants shall follow the testing 
notice issued by the central competent authori ty, pay the testing fee by the designated 
deadline, and submit sufficient samples necessary for testing to conduct testing procedures. 
However, this does not apply to those exclusively for export.  
 
Registration particulars for the license referred to in P aragraph 1 are as follows:  
1. Chinese and English product names.  
2. Name of the medical device firm.  
3. Name and address of the medical device manufacturer.  
4. Effectiveness, intended use, or indication.  
5. Ingredients, materials, structures, specifications, or model  number of the medical 
device.  
6. Labels, instructions, or packaging.  
7. Manufacturing license number.  
8. Other registration particulars that have been designated by the central competent 
authority.  
 
Article 7  
After receiving an application of registration and market approval, the central competent 
authority shall conduct a formality review of application documents and information.  
 
If the formality review set forth in the preceding paragraph finds application documents 
and information are not ready such that corrections can be made, the central competent 
authority shall notify the applicant to make corrections within one month. Failure to make 
corrections by the designated deadline shall subject the application  to rejection.  
 
Article 13  
If registration particulars of the license, labels, instructions, or packaging are changed relating to any of the following subparagraphs, documents and information in Appendix 4 
shall be submitted and fee shall be paid for subm ission of an application to the central 
competent authority:  
1. Chinese product name.  
2. English product name.  
3. Labels, instructions, or packaging.  
4. Ingredients, materials, structures, specifications, or model number.  
5. Effectiveness, intended use, or indication .  
6. Name of the manufacturer.  
7. Address of the manufacturer or country of manufacture.  
8. License holder.  
9. Name of the license holder.  
10. Manufacturing license number.  
 
When the approved document of license or labels, instructions, or packaging is lost or 
damage d, documents and information in Appendix 4 shall be submitted and fee shall be 
paid to apply for replacement or re -issuance.  
 
If the central competent authority finds that documents and information referred to in the 
preceding two paragraphs are not ready such that corrections can be made, it shall notify 
the applicant to make corrections within three months. Failure to make corr ections by the 
designated deadline shall subject the application to rejection.  
 
For applications of re -issuance or replacement of license as referred to in Paragraph 2, the 
applicant shall, within three months after the arrival date of the notice, pay the  license fee 
and obtain the license from the central competent authority. Failure to obtain the license by 
the deadline may subject its license to cancellation by the central competent authority.  
 
For applications referred to in Paragraphs 1 and 2, the ce ntral competent authority shall 
annotate the original license with the changed registration particulars and date, and return it 
after stamping.  
 
Article 13 -1  
For items announced by the central competent authority to apply for the change referred to 
in Sub paragraph 4 or 7 of Paragraph 1 of the preceding article, the provisions of Paragraph 
2 of Article 3 shall apply mutatis mutandis.  
 
Article 14  
Under any of the following circumstances, license holders may, of their own accord, change labels, instructions,  or packaging of the medical devices, and such changes shall be 
documented accordingly:  
1. No changes in the text content:  
(1) Only changing the material, shape, graphic design, color or luster of labels, 
instructions, or outer box and the graphic design not bein g offensive, indecent, or 
misleading.  
(2) Due to different packaging quantities, resizing the approved graphic design or text to fit 
a different size of packaging, or repositioning the approved graphic design or text.  
(3) Changing the fonts of the approved text,  and its font size of English text not being 
larger than that of Chinese text for the product name.  
(4) Adding printings on outer boxes or using new outer boxes to replace the affixed labels, 
and their design of text and graphs being identical to those in the  originally approved 
labels.  
2. Changes of the following text content:  
(1) Adding or changing barcode, recycling mark, “QMS/GMP ” characters of a medical 
device QMS/GMP manufacturer, CE mark, suggested retail price, customer service 
telephone line, manufacturer ’s telephone number, fax number, contact office, copyright 
registration number or company trademark approved by Taiwan Intellectual Property 
Office, CNS mark or trademark registration number, information of representative in 
other countries or areas.  
(2) Adding or changing distributor ’s name or address, and the font size of distributor ’s 
name not larger than that of medical device manufacturer ’s (license holder ’s) name.  
(3) Adding or changing the name of medical device firm, or the name or address of 
manufacturer th at has been approved for change by the central competent authority.  
(4) Adding, deleting, or changing the name of medical device firm that has been approved 
for change by the central competent authority and that constitutes part of the Chinese 
and English pro duct names.  
(5) Adding, deleting or changing international symbols representing approval and 
registration particulars on the license.  
3. Adding, deleting or changing the content according to the announcements made in 
accordance with Subparagraph 10, Paragraph 1,  Article 33 of the Act.  
 
Article 20  
Applicants who apply for a listing to manufacture or import medical devices shall list the 
following documents and information in the medical device listing system (hereinafter 
referred to as “the Listing System ”) established by the central competent autho rity, upload 
relevant documents and information as stipulated in Appendix 5 and pay the fee to obtain a 
listing number:  
1. Chinese and English product names.  2. Name of the medical device firm.  
3. Name and address of the manufacturer.  
4. Item name and number of th e medical device classification.  
5. Sterility condition of the medical device.  
6. Status of the manufacturer in conforming to the Medical Device Quality Management 
System Regulations.  
7. Other documents and information designated by the central competent authori ty.  
 
The provisions of Article 4 shall apply mutatis mutandis to the product names of medical 
devices in the preceding paragraph.  
 
Article 21  
With the exception of Subparagraph 4, those that change the listing particulars of any 
subparagraph referred to in Paragraph 1 of the preceding article shall apply for the change 
in the Listing System and pay the fee.  
 
For the aforementioned application of change, the previous Article shall apply mutatis 
mutandis for applicants to upload the documents and informatio n.   
 
Changes to name of the medical device firm referred to in Subparagraph 2 of Paragraph 1 
of the preceding article shall be limited to those that do not involve transfer of rights.  
 
Changes to item name and number of the medical device classification r eferred to in 
Subparagraph 4 of Paragraph 1 of the preceding article shall not apply for a listing change.  
 
Article 26  
The Regulations shall be implemented on May 1, 2021.  
 
Amendments to the Regulations shall be implemented on t he date of promulgation.Appendix 1: Documents and information that shall be submitted for an 
application of registration and market approval to manufacture or 
import Class 1 medical devices  
 
   Application Category  
Item Manufacture  Import  
1 Application form for Class 1 medical device 
registration and market approval  ○ ○ 
2 Copy of the medical device business permit  ○ ○ 
3 Document verifying that medical device 
manufacturer conforms to the Medical Device 
Quality Management System Regulations  △ △ 
4 Instructions of product from the original 
manufacturer  △ △ 
5 Test specifications and methods for preclinical 
testing and the test reports  △ △ 
6 Other documents and information designated by the 
central competent authority  △ △ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted. △: Indicates it would be 
dependent on the case.  
2. Copy of the medical device business permit:  
(1) Those who manufacture medical devices shall attach a copy of the medical 
device manufacturing permit. Those who import medical devices shall attach a 
copy of the medical device dealer permit showing that the business category 
includes “medical device import. ”  
(2) For domestic contract manufacturing, both the contract party and the contract 
manufacturer ’s medical de vice business permits shall be submitted.  
3. Document verifying that medical device manufacturer conforms to the Medical 
Device Quality Management System Regulations: This document refers to a copy of 
the certification document issued by the central competen t authority stating that the 
medical device manufacturer conforms to the Medical Device Quality Management 
System Regulations. However, this shall not be required for items that, as product 
items announced by the central competent authority, do not need to  obtain 
manufacturing license.  4. Instructions of product from the original manufacturer: They shall include the 
instructions for use, function, working principle, explanation of product 
composition (or ingredients), and the contents of which shall be suffic ient to 
determine that the medical product meets the identification of Class 1 classification.  
5. Test specifications and methods of preclinical testing and the test reports: These 
documents shall be submitted if the product performance/specifications have be en 
described in the identification provisions of Class 1 medical device product items or 
announced by the central competent authority pursuant to Article 30 of the Act.  
6. Other documents and information designated by the central competent authority:  
(1) If the product name bears a trademark, relevant information related to trademark 
registration shall be submitted. If the product name bears the name or trademark 
of another firm, a consent letter issued by the firm shall be submitted.  
(2) In line with the Consolidate d List of Commodities Subject to Import Restriction 
and Commodities Assisted by Customs for Import Examination announced by 
the Bureau of Foreign Trade of the Ministry of Economic Affairs, medical 
devices imported from China shall first obtain permit for i mport from the 
Bureau of Foreign Trade of the Ministry of Economic Affairs before applying 
for registration and market approval from the central competent authority.  
(3) If the name of the product bears a proper noun for performance/specification of 
a specific  country or international organization standards, supporting documents 
issued by the country or the region, a third -party validation agency, or the 
international organization should be attached.  
  Appendix 2 : Documents and information that shall be submitt ed for an 
application of registration and market approval to manufacture or 
import Class 2 or Class 3 medical devices  
 
 
    Application  
     Category  
 
 
 
 
Documents and 
Information to be 
Submitted  Class 2  
Medical Devices  Class 3  
Medical Devices  Same Product with  
Different Product 
Names  Exclusively 
for Export  
Manufacture  Import  Manufacture  Import  Manufacture  Import  Manufacture  
1 Application 
form for 
medical device 
registration and 
market approval  ○ ○ ○ ○ ○ ○ ○ 
2 Two copies of 
draft labels, 
instructions , or 
packaging  ○ ○ ○ ○ ○ ○ ╳ 
3 Copy of the 
medical device 
business permit  ○ ○ ○ ○ ○ ○ ○ 
4 Original of the 
manufacture and 
free sale 
certificate of the 
country of 
origin  ╳ △ ╳ △ ╳ ○ ╳ 
5 Original of the 
foreign original 
manufacturer 
authorization 
letter  ╳ ○ ╳ ○ ╳ ○ ╳ 
6 Document 
verifying that 
medical device 
manufacturer 
conforms to the 
Medical Device 
Quality 
Management 
System 
Regulations  ○ ○ ○ ○ ╳ ╳ ○ 7 Test 
specifications 
and methods of 
preclinical 
testing and 
quality control 
conducted by 
the original 
manufacturer, 
the original test 
records, and the 
test reports  △ △ ○ ○ ╳ ╳ ╳ 
8 Documents 
relating to 
product 
structures, 
materials, 
specifications, 
functions, 
intended uses, 
and drawings  ○ ○ ○ ○ ╳ ╳ ╳ 
9 Clinical 
evidence 
information  △ △ △ △ ╳ ╳ ╳ 
10 Radiation safety 
information for 
equipment 
generating 
ionizing 
radiation  △ △ △ △ ╳ ╳ ╳ 
11 Essential 
Principles (EP) 
of Safety and 
Performance of 
Medical Devices 
and Summary 
Technical 
Documentation 
(STED)  ╳ △ ○ ○ ╳ ╳ ╳ 
12 Original of the 
manufacturer’s 
letter explaining 
that the product 
is the same 
product with 
different product 
names  ╳ ╳ ╳ ╳ ○ ○ ╳ 13 Copy of the 
originally 
approved labels, 
instructions, or 
packaging 
stamped with 
tally impression 
of the central 
competent 
authority  ╳ ╳ ╳ ╳ ○ ○ ╳ 
14 Copy of the 
originally 
approved 
medical device 
license  ╳ ╳ ╳ ╳ ○ ○ ╳ 
15 Other 
documents and 
information 
designated by 
the central 
competent 
authority  △ △ △ △ △ △ △ 
16 Samples for 
testing  △ △ △ △ ╳ ╳ ╳ 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted. △: Indicates it would be 
dependent on the case. X: Indicates document for this item shall not be required for 
submission.  
2. Draft labels, instructions or packaging:  
(1) For those who manufacture medical dev ices, the Chinese labels, instructions, or 
packaging and draft color pictures of the actual product appearance.  
(2) For those who import medical devices, the original labels, instructions, or 
packaging, the draft detailed Chinese instructions and draft color pictures of the 
actual product appearance.  
3. Copy of the medical device business permit:  
(1) Those who manufacture med ical devices shall attach a copy of the medical 
device manufacturing permit. Those who import medical devices should attach a 
copy of the medical device dealer permit showing that the business category 
includes “medical device import. ” 
(2) For domestic contrac t manufacturing, both the contract party and the contract 
manufacturer's medical device business permits shall be submitted.  
4. Manufacture and free sale certificate of the country of origin:  
(1) This document shall record the following particulars:  ① Name and spe cifications and/or model number of the medical device.  
② Manufacturer ’s name, address, manufacturing status, and actual status for 
domestic sale as approved in that country.  
(2) This document may be replaced by a document issued by other authorities or 
another document in accordance with the following provisions:  
① If the medical device is not regulated by the highest health authority in 
manufacturer ’s country, this document may be issued by the local health 
agency or an organization approved by the central compet ent authority of 
the Republic of China (Taiwan).  
② If the medical device is commissioned to be manufactured, this document 
may be issued by the highest health authority in the country where the 
contract party or the contract manufacturer is located.  
③ If the medical device involves contract manufacturing and it is not sold in 
the country where the contract manufacturer is located, this document may 
be replaced by a free sale certificate issued by the highest health authority in 
the country where the contract p arty is located, and a manufacture certificate 
issued by the government of the country where the contract manufacturer is 
located.  
④ This document may be replaced by a manufacture certificate issued by the 
government of manufacturer ’s country and a free sale  certificate issued by 
the highest health authority of the United States of America or of a European 
Union Member State.  
⑤ If the medical device is a world ’s first product with no predicate, a report 
from the central competent authority after conducting an o n-site inspection 
of the foreign medical device manufacturer and a report of medical device 
clinical trials carried out in the Republic of China (Taiwan) shall be 
submitted for the exemption from submitting the manufacture and free sale 
certificate of the country of origin.  
(3) This document shall remain valid for two years from the date of issuance, and 
shall be notarized by the Republic of China ’s (Taiwan ’s) overseas embassy or 
consulate, representative office, other official office stationed in the region, or 
overseas organization authorized by the Ministry of Foreign Affairs (hereafter 
referred to as the ROC overseas representative office). If the certification 
document is not issued in English, a Chinese or English translation shall be 
submitted at the sam e time and the translation shall be notarized. However, 
those issued by the highest health authority of a country that has established 
technical cooperation agreement with the Republic of China (Taiwan) for the 
premarket review of medical devices or those recognized by the central 
competent authority are exempt from notarization.  5. Foreign original manufacturer authorization letter:  
(1) This document shall record the following particulars:  
① The original manufacturer authorizes an agent in the Republic of China 
(Taiwan) to apply for registration and market approval and agrees to 
coordinate with the agent in the Republic of China (Taiwan) to comply with 
relevant medical device regulatory requirements.  
② It specifies the name and address of medical device firm commissioned or 
authorized to register, as well as the name and specifications and/or model 
number of medical device.  
(2) This document may be replaced by other documents in accordance with the 
followin g provisions:  
① A certification document for authorized agent issued by the headquarter 
company of the imported medical devices that authorizes the agent in the 
Republic of China (Taiwan) to apply for registration and market approval. 
Its contents explicitly  state the name and address of manufacturer and 
specify the name and address of medical device firm commissioned or 
authorized to register, as well as the name and specifications and/or model 
number of medical device.  
② The original manufacturer of imported medical devices issues a certification 
document stating its foreign agent, and then the foreign agent issues a 
certification document for authorized agent, which authorizes the agent in 
the Republic of China (Taiwan) to apply for registration and market 
approval and explicitly states the name and address of medical device firm 
commissioned or authorized to register, as well as the name and 
specifications and/or model number of medical device.  
(3) This document shall remain valid for one year from the date of i ssuance. If it is 
not issued in English, a Chinese or English translation shall also be submitted at 
the same time.  
6. Document verifying that medical device manufacturer conforms to the Medical 
Device Quality Management System Regulations:  
(1) This document ref ers to the certification document issued by the central 
competent authority stating that the medical device manufacturer conforms to 
the Medical Device Quality Management System Regulations.  
(2) For medical devices that were originally regulated as pharmaceut icals and 
within three years from the date of announcing the regulatory change to medical 
devices, this document may be replaced by a copy of the certification document 
showing conformance to the Good Manufacturing Practices for 
Pharmaceuticals.  
7. Test spec ifications and methods of preclinical testing and quality control conducted by the original manufacturer, the original test records, and the test reports:  
(1) This document shall include information on safety and performance testing that 
has been conducted to ensure the claimed efficacy, structure, materials, design, 
and quality of the product.  
(2) For Class 2 medical devices with predicate device(s) that have been approved 
for marketing by the central competent authority, this document may be 
replaced by one of t he following documents:  
① Marketing approval certification document issued by the government of a 
country that has established technical cooperation agreement with the 
Republic of China (Taiwan) for the premarket review of medical devices, as 
well as Essenti al Principles (EP) of Safety and Performance of Medical 
Devices and Summary Technical Documentation (STED).  
② Affidavit of preclinical testing conformity for medical device that is a 
product announced by the central competent authority whose manufacturer 
has a predicate device of the same classification and approved for marketing 
by the central competent authority.  
(3) For Class 2 medical devices in Appendix 3, if the applicant has obtained the 
license showing that the same medical device manufacturer has manuf actured a 
predicate device of the same item and the license is still within the validity 
period, this document may be replaced by the Class 2 medical device product 
comparison and preclinical test data conformity statement, with the exception of 
medical de vices containing medicine.  
(4) For medical devices that require testing as announced by the central competent 
authority, two copies of this document shall be submitted.  
(5) Commissioned laboratories that conduct the biocompatibility, electrical safety, 
and electro magnetic compatibility (EMC) testing shall conform to any of the 
following requirements:  
① Conform to the provisions of ISO/IEC 17025.  
② Conform to the provisions of Good Laboratory Practice for Nonclinical 
Laboratory Studies (GLP).  
8. Documents relating to pro duct structures, materials, specifications, functions, 
intended uses, and drawings: For instrument products, the operation manual and 
maintenance manual that cover these documents may replace them.  
9. Clinical evidence information:  
(1) This document includes:  
① Academic and theoretical bases, relevant research reports and data.  
② Clinical evaluation report or clinical trial report.  
(2) The central competent authority shall determine or announce whether or not the 
medical device applying for registration and market ap proval requires clinical trials in the Republic of China (Taiwan) by considering the medical device 
product item, individual case, and data submitted by applicant.  
(3) For medical devices with predicate device(s) that have been approved for 
marketing by the ce ntral competent authority, unless it is necessary to verify 
their safety and effectiveness with clinical evidence, this document may be 
exempt from submission.  
(4) For Class 2 medical devices without predicate device, unless otherwise 
specified, the clinical trial report may be replaced by supporting data that meets 
all the following conditions:  
① There are no ethnic differences in the expected effectiveness of this product.  
② There are no serious adverse reports related to the claimed intended use or 
indication f or such type of product in foreign countries, and the product has 
not been required to be removed from the market.  
③ Preclinical data (including trial) may be used to demonstrate that the 
differences between the product and domestic products that have been 
approved for marketing will not affect the product ’s safety and 
effectiveness; or marketing approval certification documents of the United 
States of America and the European Union may be provided and the 
indication under application does not exceed the scop e approved by the 
United States of America and the European Union.  
10. Radiation safety information for equipment generating ionizing radiation: For 
medical devices generating ionizing radiation, this document shall be submitted.  
11. Essential Principles (EP) of  Safety and Performance of Medical Devices and 
Summary Technical Documentation (STED):  
(1) The format of this document shall follow the announcement of the central 
competent authority.  
(2) For Class 2 medical devices under application with the circumstances in 
Paragraph (2) ① of Section 7, this document shall be submitted.  
12. Manufacturer's letter explaining that the product is the same product with different 
product names: It shall explain th at the product for which a new application has 
been made and the originally approved product are identical products, and indicate 
clearly the medical device license number that was originally approved.  
13. Other documents and information designated by the cent ral competent authority:  
(1) For medical devices using bovine or ovine/hircine tissues, an explanation of 
animal raw material source control procedures and proof of raw material source 
from the original manufacturer shall be submitted in order to verify that t he 
processes associated with the medical device and the ultimate finished product 
do not use any bovine or ovine/hircine product from the bovine spongiform 
encephalopathy (BSE) epidemic areas announced by the Council of Agriculture, Executive Yuan, and hav e not been contaminated by BSE pathogens. However, 
for applications conforming to the announcement from the central competent 
authority regarding the exemption from submitting the aforementioned 
documentation after considering the international regulatory guidelines for 
controlling bovine or ovine/hircine tissues in accordance with the risk of 
contamination of the tissues by BSE pathogen, this provision shall not apply.  
(2) If the product name bears a trademark, relevant information related to trademark 
regist ration shall be submitted. If the product name bears the name or trademark 
of another medical device firm, a consent letter issued by the firm shall be 
submitted.  
(3) In line with the Consolidated List of Commodities Subject to Import Restriction 
and Commoditi es Assisted by Customs for Import Examination announced by 
the Bureau of Foreign Trade of the Ministry of Economic Affairs, medical 
devices imported from China shall first obtain permit for import from the 
Bureau of Foreign Trade of the Ministry of Economi c Affairs before applying 
for registration and market approval from the central competent authority.  
(4) For medical devices exclusively for export, the instructions for use, function, 
working principle, and explanation of product composition (or ingredients)  shall 
be submitted, and the contents of which shall be sufficient to determine that this 
product meets the identification of the product item under application.  
(5) If the name, the label, instructions or packaging of the product bears a proper 
noun for perfo rmance/specification of a specific country or international 
organization standards, supporting documents issued by the country or the 
region, a third -party validation agency, or the international organization should 
be attached.  
14. Samples for testing: For items announced in Paragraph 2 of Article 3, the applicant 
shall follow the testing notice, pay the testing fee by the designated deadline, and 
submit sufficient samples for testing to conduct testing procedures.  
  Appendix 3: “Applicable Product Items for Class 2 Medical Device 
Product Comparison and Preclinical Test Data Conformity 
Statement ” mentioned in Section 7 of the Instructions in Appendix 2  
 
 Item Number  Name  
1 A.1020  Acid phosphatase (total or prostatic) test system  
2 A.1025  Adrenocorticotropic hormone (ACTH) test system  
3 A.1035  Albumin test system  
4 A.1050  Alkaline phosphatase or iso enzymes test system  
5 A.1070  Amylase test system  
6 A.1110  Bilirubin (total or direct) test system  
7 A.1150  Calibrator  
8 A.1155  Human chorionic gonadotropin (HCG) test system  
9 A.1215  Creatine phosphokinase/creatine kinase or isoenzymes test 
system  
10 A.1345  Glucose test system  
11 A.1660  Quality control material (assayed and unassayed)  
12 A.1675  Blood specimen collection device  
13 B.5400  Coagulation instrument  
14 B.5425  Multipurpose system for in vitro coagulation studies  
15 B.7470  Glycosylated hemoglobin assay  
16 B.8625  Hematology quality control mixture  
17 C.0002  Dengue virus serological reagents  
18 C.2410  Culture medium for pathogenic Neisseria spp  
19 C.3305  Herpes simplex virus serological reagents  
20 C.3390  Neisseria spp. Direct serological test reagents  
21 C.3860  Trichomonas vaginalis nucleic acid assay  
22 C.5100  Antinuclear antibody immunological test system  
23 C.5270  C-reactive protein immunological test system  
24 C.5510  Immunoglobulins A, G, M, D, and E immunological test 
system  
25 C.5750  Radioallergosorbent (RAST) immunological test system  
26 C.5775  Rheumatoid factor immunological test system  
27 D.5630  Nebulizer  
28 D.5710  Electrically powered oxygen tent  
29 D.5730  Tracheal tube  30 D.5800  Tracheostomy tube and tube cuff  
31 D.5915  Manual emergency ventilator  
32 E.0005  Percutaneous transluminal coronary angioplasty (PTCA)   
catheter  
33 E.1130  Noninvasive blood pressure measurement system  
34 E.1200  Diagnostic intravascular catheter  
35 E.1210  Continuous flush catheter  
36 E.1220  Electrode recording catheter or electrode recording probe  
37 E.1280  Steerable catheter  
38 E.1310  Vessel dilator for percutaneous catheterization  
39 E.1330  Catheter guide wire  
40 E.1340  Catheter introducer  
41 E.1650  Angiographic injector and syringe  
42 E.2340  Electrocardiograph  
43 E.2360  Electrocardiograph electrode  
44 E.2700  Oximeter  
45 E.2900  Patient  transducer and electrode cable (including connector)  
46 E.3450  Vascular graft prosthesis  
47 E.4450  Vascular clamp  
48 E.5150  Embolectomy catheter  
49 E.5900  Thermal regulati ng system  
50 F.1745  Laser fluorescence caries detection device  
51 F.1800  Extraoral source x -ray system  
52 F.1810  Intraoral source x -ray system  
53 F.3060  Gold based alloys and precious metal alloys for clinical use  
54 F.3200  Resin tooth bonding agent  
55 F.3275  Dental cement  
56 F.3590  Preformed plastic denture tooth  
57 F.3630  Endosseous dental implant abutment  
58 F.3660  Impression material  
59 F.3690  Tooth shade resin material  
60 F.3765  Pit and fissure sealant and conditioner  
61 F.3820  Root canal filling resin  
62 F.4760  Bone plate  
63 F.4850  Ultrasonic scaler  
64 F.6070  Ultraviolet activator for polymerization  
65 F.6660  Porcelain powder for clinical use  66 G.4250  Ear, nose, and throat electric or pneumatic surgical drill  
67 H.1075  Gastroenterology -urology biopsy instrument  
68 H.1500  Endoscope and accessories  
69 H.4620  Ureteral stent  
70 H.5010  Biliary catheter and accessories  
71 H.5130  Urological catheter and accessories  
72 H.5470  Ureteral dilator  
73 H.5540  Blood access device and accessories  
74 H.5630  Peritoneal dialysis system and accessories  
75 H.5820  Hemodialysis system and accessories  
76 H.5980  Gastrointestinal tube and accessories  
77 I.0003  Ultrasonic surgical instrument  
78 I.0006  Medical protective clothing  
79 I.4010  Tissue adhesive  
80 I.4014  Nonresorbable gauze/sponge for external use  
81 I.4018  Hydrophilic wound dressing  
82 I.4020  Occlusive wound/burn dressing  
83 I.4022  Hydrogel wound dressing and burn dressing  
84 I.4370  Surgical drape and drape accessories  
85 I.4400  Electrosurgical cutting and coagulation device and accessories  
86 I.4493  Absorbable poly(glycolide/L -lactide) surgical suture  
87 I.4495  Stainless steel suture  
88 I.4580  Surgical lamp  
89 I.4780  Power suction pump  
90 I.4810  Laser surgical instrument for use in general and plastic surgery 
and in dermatology  
91 I.4830  Absorbable surgical gut suture  
92 I.4840  Absorbable polydioxanone surgical suture  
93 I.5000  Nonabsorbable poly (ethylene terephthalate) surgical suture  
94 I.5010  Nonabsorbable polypropylene surgical suture  
95 I.5020  Nonabsorbable polyamide surgical suture  
96 I.5030  Natural nonabsorbable silk surgical suture  
97 I.5035  Nonabsorbable expanded polytetrafluoroethylene surgical 
suture  
98 J.2800  Sterilization process indicator  
99 J.2910  Clinical electronic thermometer  
100 J.5090  Liquid bandage  101 J.5200  Intravascular catheter  
102 J.5240  Medical adhesive tape and adhesive bandage  
103 J.5440  Intravascular administration set  
104 J.5570  Hypodermic single lumen needle  
105 J.5700  Neonatal phototherapy unit  
106 J.5860  Piston syringe  
107 J.5965  Subcutaneous, implanted, intravascular infusion port and 
catheter  
108 J.5970  Percutaneous, implanted, long -term intravascular catheter  
109 J.6850  Sterilization wrap  
110 K.4305  Powered compound cranial drills, burrs, trephines, and their  
accessories  
111 K.4310  Powered simple cranial drills, burrs, trephines,  and their 
accessories  
112 K.4360  Electric cranial drill motor  
113 K.4370  Pneumatic cranial drill motor  
114 K.4840  Manual rongeur  
115 L.1690  Hysteroscope and accessories  
116 L.1720  Gynecologic laparoscope and accessories  
117 L.1730  Laparoscopic insufflator  
118 L.4150  Bipolar endoscopic coagulator -cutter and accessories  
119 L.6100  Assisted reproduction needles  
120 L.6110  Assisted reproduction catheters  
121 L.6130  Assisted reproduction microtools  
122 M.1120  Ophthalmic camera  
123 M.1570  Ophthalmoscope  
124 M.1850  AC-powered slitlamp biomicroscope  
125 M.4150  Vitreous aspiration and cutting instrument  
126 M.4670  Phacofragmentation system  
127 M.4790  Ophthalmic sponge  
128 M.5918  Rigid gas permeable contact lens care products  
129 M.5925  Soft (hydrophilic) contact lens  
130 M.5928  Soft (hydrophilic) contact lens care products  
131 N.1100  Arthroscope  
132 N.3027  Polymethylmethacrylate (PMMA) bone cement  
133 N.3045  Resorbable calcium salt  bone void filler device  
134 N.3050  Spinal interlaminal fixation orthosis  135 N.3060  Spinal intervertebral body fixation orthosis  
136 N.3070  Pedicle screw spinal system  
137 O.0001  Static electric therapy apparatus  
138 O.3860  Powered wheelchair  
139 O.5500  Infrared lamp  
140 P.1570  Diagnostic ultrasonic transducer  
 Appendix 4: Documents and information that shall be submitted for an 
application of change, re -issuance, or replacement of medical device 
license  
 
 Item to be 
Changed  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Documents  
and Information to  
be Submitted  Chinese product name  English product name  Labels, Instructions, or Packaging  Ingredients, Materials, Structures, Specifications, or Model number  Effectiveness, Intended Use, or Indication  Name of the Manufacturer  Address of the Manufacturer or Country of Manufacture  License Holder  Name of the License Holder  Re-issuance or Replacement of a Lost or Damaged License  Manufacturing license number  
1 Application form 
for change of 
medical device 
license  ○ ○ ○ ○ ○ ○ ○ ○ 
Note 
9 ○ ○ ○ 
2 Application form 
for medical 
device 
registration and 
market approval  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ △ 
Note 
13 ╳ 
3 Original license  ○ ○ ○ ○ ○ ○ ○ ○ ○ △ 
Note 
14 ○ 4 Copy of the 
originally 
approved labels, 
instructions, or 
packaging 
stamped with 
tally impression 
of the central 
competent 
authority  ╳ ╳ ○ △ 
Note 
2 ○ ╳ ╳ ╳ ╳ △ 
Note 
15 ╳ 
5 Two copies of 
draft labels, 
instructions , or 
packaging  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ △ 
Note 
16 ╳ 
6 Copy of the 
medical device 
business permit  ╳ ╳ ╳ ╳ ╳ △ 
Note 
5 △ 
Note 
5 ○ 
Note 
10 ○ 
Note 
12 ╳ ╳ 
7 Original of the 
manufacture and 
free sale 
certificate of the 
country of origin  ╳ △ 
Note 
1 ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
6 ╳ ╳ ╳ ╳ 
8 Original of the 
foreign original 
manufacturer 
authorization 
letter  ╳ ╳ ╳ △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
4 △ 
Note 
11 ╳ ╳ ╳ 
9 Document 
verifying that 
medical device 
manufacturer 
conforms to the 
Medical Device 
Quality 
Management 
System 
Regulations  ╳ ╳ ╳ ╳ ╳ ○ ○ ╳ ╳ ╳ ○ 10 Test 
specifications and 
methods of 
preclinical testing 
and quality 
control conducted 
by the original 
manufacturer, the 
original test 
records, and the 
test reports  ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note
7 
Note 
8 ╳ ╳ ╳ ╳ 
11 Documents 
relating to 
product 
structures, 
materials, 
specifications, 
functions, 
intended uses, 
and drawings  ╳ ╳ ╳ △ 
Note 
3 ○ ╳ △ 
Note
7 
Note 
8 ╳ ╳ ╳ ╳ 
12 Clinical evidence 
information  ╳ ╳ ╳ △ 
Note 
3 △ ╳ ╳ ╳ ╳ ╳ ╳ 
13 Radiation safety 
information for 
equipment 
generating 
ionizing radiation  ╳ ╳ ╳ △ 
Note 
3 ╳ ╳ ╳ ╳ ╳ ╳ ╳ 
14 Original of the 
manufacturer’s 
letter that 
explains the 
change  ╳ ○ ○ △ 
Note 
3 ○ ○ ○ ╳ ╳ ╳ ╳ 
15 Comparison table 
of changed and 
originally 
approved content  ╳ ╳ ○ △ 
Note 
3 ○ ╳ ╳ ╳ ╳ ╳ ╳ 16 Transfer 
statement co -
signed by the 
transferor and 
transferee  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ ╳ 
17 Statement from 
the medical 
device firm 
receiving the 
transferred 
license 
(transferee) 
affirming the 
responsibility for 
the transferred 
medical device  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ ╳ 
18 Statement  
from the medical 
device firm after 
name change 
affirming the 
responsibility for 
every item on the 
changed license  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
19 Statement 
claiming that 
change in the 
name of a 
medical device 
firm holding the 
medical device 
license does not 
involve transfer 
of rights  ╳ ╳ ╳ ╳ ╳ ╳ ╳ ╳ ○ ╳ ╳ 
20 Other documents 
and information 
designated by the △ △ △ △ △ △ △ △ △ △ 
Note 
17 △  
Instructions:  
I. ○: Indicates document for this item shall be submitted. △: Indicates it would be 
dependent on the case. ╳: Indicates document for this item shall not be required for 
submission.  
II. Please refer to the instructions of Appendix 2 for relevant regulations on: draft labels, 
instructions, or packaging; copy of the medic al device business permit; manufacture 
and free sale certificate of the country of origin; foreign original manufacturer 
authorization letter; document verifying that medical device manufacturer conforms 
to the Medical Device Quality Management System Regu lations; test specifications 
and methods of preclinical testing and quality control conducted by the original 
manufacturer; original test records and test reports; documents relating to product 
structure, materials, specifications, functions, intended uses , and drawings; clinical 
evidence information; radiation safety information for equipment generating ionizing 
radiation; other documents designated by the central competent authority; and 
samples for testing.  
Notes:  
1. The manufacture and free sale certificate of the country of origin shall be able to 
indicate that the changed product and the originally approved product are the same. 
For domestically manufactured medical devices, it is exempt from submission.  
2. This is exempt from submission if the cha nge of specifications does not involve 
changing the originally approved labels, instructions, or packaging.  
3. This is exempt from submission for deletion of specifications.  
4. For domestically manufactured medical devices, this is exempt from submission. 
For d eletion of specifications, this is exempt from submission.  
5. For domestically manufactured medical devices, a copy of new firm's medical 
device manufacturing permit shall be submitted. For imported medical devices, this 
is exempt from submission.  
6. For domest ically manufactured medical devices, this is exempt from submission. If central competent 
authority  
21 Samples for 
testing  ╳ ╳ ╳ △ 
Note 
18 ╳ ╳ △ 
Note 
18 ╳ ╳ ╳ ╳ the change of manufacturer's address was due to house numbering system change, 
this document may be exempt but certificate document issued by a government 
agency shall be submitted; in  the case of imported medical devices, it shall be 
notarized by ROC overseas representative office.  
7. If the application for change involves a Class 3 in vitro diagnostic medical device , 
this information shall be attached. For applications for change of othe r products, the 
central competent authority may, when necessary, order submission of this 
document.  
8. For medical devices that require testing as announced by the central competent 
authority, two copies of this document shall be submitted.  
9. The change of lice nse holder shall be applied jointly by the transferor and 
transferee.  
10. This refers to a copy of the transferee's medical device business permit.  
11. The foreign original manufacturer authorization letter shall explain in detail about 
termination of the rights  of the transferor, and bestowing of such rights to the 
transferee, and shall state the product name and the names and addresses of 
transferor and transferee. For domestically manufactured medical devices, it is 
exempt from submission.  
12. This refers to a co py of the transferee's medical device business permit after name 
change.  
13. This document shall be submitted when applying for re -issuance or replacement of 
a lost or damaged license. It is exempt from submission when applying for re -
issuance or replacement o f lost or damaged labels, instructions, or packaging.  
14. This is exempt from submission when applying for re -issuance of a lost license.  
15. This document shall be submitted when applying for replacement of damaged 
labels, instructions, or packaging. It is exemp t from submission when applying for 
re-issuance or replacement of a lost or damaged license and re -issuance of lost 
labels, instructions, or packaging.  
16. This document shall be attached when applying for re -issuance or replacement of 
lost or damaged labels,  instructions, or packaging. It is exempt from submission when applying for re -issuance or replacement of a lost or damaged license.  
17. When applying for re -issuance of a lost license, a statement declaring that the 
original license has indeed been lost shal l be submitted. When applying for re -
issuance or replacement of lost or damaged labels, instructions, or packaging, a 
statement declaring that the original labels, instructions, or packaging has indeed 
been lost shall be submitted.  
18. The applicant shall follow the testing notice, pay the testing fee by the designated 
deadline, and submit sufficient samples for testing to conduct testing procedures.  
  Appendix 5 : Documents and information that shall be uploaded for an 
application for a listing to manufacture or import Class 1 medical devices  
 
 
Instructions:  
1. ○: Indicates document for this item shall be submitted. △: Indicates it would be 
dependent on the case.  
2. Copy of the medical device business permit:  
(1) Those who manufacture medical devices shall upload a copy of the medical 
device manufacturing permit. Those who import medical devices shall upload a 
copy of the medical device dealer permit showing that the business category 
includes “medical device impor t”. 
(2) For domestic contract manufacturing, both the contract party and the contract 
manufacturer's medical device business permits shall be uploaded.  
3. Document verifying that medical device manufacturer conforms to the Medical 
Device Quality Management System  Regulations: This document refers to a copy of 
the certification document issued by the central competent authority stating that the 
medical device manufacturer conforms to the Medical Device Quality Management 
System Regulations.  However, this is shall not be required for items that, as product 
items announced by the central competent authority, do not need to obtain 
manufacturing license.  
4. Instructions of product from the original manufacturer: They shall include the 
instructions for use, function, working principle, explanation of product composition 
(or ingredients), and the contents of which shall be sufficient to determine that the 
medic al product meets the identification of Class 1 classification. For items 
designated by the listing system, this document should be uploaded.   
Item Upload 
1 Copy of the medical device business permit  ○ 
2 Document verifying that medical device manufacturer 
conforms to the Medical Device Quality Management 
System Regulations  △ 
3 Instructions of product from the original manufacturer  △ 
4 Test specifications and methods for preclinical testing 
and the test reports  △ 
5 Other documents and information designated by the 
central competent authority  △ 5. Test specifications and methods of preclinical testing and the test reports: These 
documents shall be uploaded if the product performance/specifications have been 
described in the identification provisions of Class 1 medical device product items or 
announced by the central competent authority pursuant to Article 30 of the Act.  
6. Other documents and information designated  by the central competent authority : 
(1) If the product name bears a trademark, relevant information related to trademark 
registration shall be uploaded. If the product name bears the name or trademark 
of another firm, a consent letter issued by the firm shall  be uploaded.  
(2) In line with the Consolidated List of Commodities Subject to Import Restriction 
and Commodities Assisted by Customs for Import Examination announced by 
the Bureau of Foreign Trade of the Ministry of Economic Affairs, medical 
devices imported from China shall first obtain permit for import from the Bureau 
of Foreign Trade of the Ministry of Economic Affairs before applying for a 
listing from the central competent authority.  
(3) If the name of the product bears a proper noun for performance/specific ation of 
a specific country or international organization standards, supporting documents 
issued by the country or the region, a third -party validation agency, or the 
international organization should be uploaded.  