1 Draft  of the Enforcement Rules of  Medical Devices Act  
This Draft has been translated into English according to the  original Chinese version. I f there is any 
inconsistency or  ambiguity between these two vers ions, the Chinese version shall  prevail.  
Articles  
Article 1 The Enforcement Rules are stipulated in accordance with the provisions of Article 84 
of Medical Devices Act (hereinafter referred to as the Act).  
Article 2 Under any of the following circumstances, the material is not considered to be 
medical device advertisements governed by Article 6 of the Act.  
1. The material only lists the product name, price, discount, specifications, material, image of 
the appearance of the product, a nd the name and address or telephone of the firms , and does 
not publicize the therapeutic effect of a product.   
2. The material is used to make announcement for a special incident and does not publicize 
the therapeutic effect of a product.   
3. The material is used to differentiate an authentic and a fake medical device and does not 
publicize the therapeutic effect of a product.   
4. The material provides complete information of approved labels and instructions and does 
not contain any content mentioned in the preceding three Subparagraphs or any content that 
aims to solicit sale.   
5. Health education material   
Article 3 The so -called health education material referred to in Subparagraph 5 of the 
preceding Article shall meet one of the following conditions:  
1. The material is used to promote health or prevent illness and does not promote a specific 
medical device.  
2. The material is provided to medical professionals  for health education of specific target 
audience  and the cont ent only describes the disease, perioperative care, a specific medical 
device, information about follow -up appointment or attentions and it does not contain any 
contact information of any medical device firm.  
Article 4 Under any of the following circumstances, health education materials referred to in 
the preceding Article will be considered as medical device advertisements:  
1. The material is printed on the same page or a continuous layout of a print advertisement of 
medical device(s).   
2. The materials is broadcasted with a dynamic medical device advertisement.   
3. The performers or endorsers of the health education material are the same persons in a 
medical device advertisement and consumers may be misled to believe that the health 
education mate rial is an advertisement.  
Article 5 The so -called “foreign objects that affect product quality are mixed or packed" with 
medical devices referred to in Subparagraph 6 of Article 8 of the Act refers to substance that 
may affect the quality is mixed or pac ked with medical devices in the complete packaging of 2 the product.  
Article 6 Terms used in Subparagraph 1 of Article 10 of the Act shall have the following 
meanings:  
1. Manufacturing: refers to the physical or chemical process(es) through which materials, 
substances or components are transformed into medical devices. Completion of 
packaging, labeling or sterilization are not considered necessary steps of manufacturing.  
2. Packaging: refers to the operation added onto the main unit of the medical device to 
main tain the value and status of a medical device. Subpackaging  is included in the 
operation.  
3. Labeling: refers to the operation of adding the label(s) of a medical device onto the 
smallest packaging unit for sale of the medical device or the main unit of the medical 
device.  
4. Final inspection and release:  refers to the operation to verify that the final medical device 
product matches the originally designed safety, therapeutic effect  and quality and so the 
medical device can be released.  
Article 7 The  so-called “repair”  referred to in Article 11 of the Act refers to the operation of 
dissembling a medical device for inspection or removing malfunctioning, damaged or 
defective parts from the medical device and restoring the medical device to good conditio n or 
restore the function. But the following situations are excluded:  
1. Cleaning of dirty medical devices.  
2. Conducting function test of a product, checking related components, replacing 
consumables according to the instruction manual or conducting other auto nomous repair 
work.  
3. Replacing defective medical device.  
4. Calibration.  
Article 8 Items required for approval and registration referred to in Paragraph 2 of Article 13 
of the Act are as follows:  
1. Type of medical device firm;  
2. Name of the medical device firm ;  
3. Business address of the medical device firm and the warehouse address of the medical 
device dealer.  
4. Name and identification card number or number of the identification document of the 
responsible person.  
5. Business items . 
6. Name and national identification card number or number of the identification document of 
the medical device technician.  
7. Items announced according to Article 18 of the Act.  
8. Operating status.  
9. Other particulars that shall be indicated, as announced by the central competent authority.  3 Article 9 According to the provisions of Paragraph 2 of Article 13 of the Act, any business with 
the intent to become a medical device firm shall file an application with the municipal or 
county/city competent authority for approval and registration and shall submit the following 
documents and information, and pay the license fees:  
1. For firms that shall employ qualified technicians, documents proving the employment 
relationship between the firm and the employee shall be submit ted.  
2. For a medical device firm organized as a company, photocopies of the company 
registration and articles of incorporation shall be submitted; for a medical device firm 
organized as business, photocopies of the business registration shall be submitted.  
3. For organizations, schools, legal persons or groups that are not companies or business, the 
consent letter of the competent authority in charge of the target business shall be 
submitted.  
4. For medical device dealers, the firm's business address, and a basi c floor plan showing the 
premises and warehouse storing medical devices and principal equipment shall be 
submitted.  
5. For medical device manufacturers that manufacture medical devices in accordance with 
the provisions of Subparagraph 1 of Article 10 of the Act, photocopies of the factory 
registration documents shall be submitted. However, firms that are exempt from factory 
registration under the Factory Management Act do not need to submit such documents.  
6. Other documents and information designated by the mu nicipal or city/county competent 
authority.  
For a newly established firm organized as a company, as referred to in Subparagraph 2 of 
the preceding Paragraph, the municipal or city/county competent authority shall first issue 
establishment permit documents  to the firm, then issue a medical device business permit to the 
firm after it obtains its corporate registration, business registration or factory registration 
documents.  
Article 10 For any business  with the intent to become a medical device firm, the p rovisions of 
Articles 9 through 11 of the Act shall be followed with respect to which type of medical device 
firm the application is for and business items  to be stated in the registration.  
Article 11 A medical device business permit  shall be hung at a conspicuous location at its place 
of business.  
Article 12 Medical device firms that have registered and obtained pharmaceutical firm's 
licenses in accordance with the provisions of Paragraph 1 of Article 2 7 of the Pharmaceutical 
Affairs Act before enforcement of the Act do not need to reapply for medical device business 
permit after the enforcement of the Act. In case that there are any change made in the 
particulars registered, the firm shall apply for cha nge of registration in accordance with the 
provisions of Paragraph 2 of Article 13 of the Act for re -issuance of medical device business 
permit.   
Article 13 For matters related to " change of registration" that shall be carried out in 4 accordance with Para graph 2 of Article 13 of the Act, medical device firms shall apply for 
change of registration to the competent authority that originally approved its registration 
within 30 days from the date of occurrence of a change.  
Article 14 When a medical device fi rm applies for change of registration in accordance with 
the provisions of Paragraph 2 of Article 13 of the Act, except for change of business address, 
for which the firm shall first apply to the municipal or city/county competent authority, change 
of regi stration pertaining to company organization or business registration matters shall first be 
carried out with the relevant competent authority for commercial matters.  
Article 15 Medical device dealers  engaging in import  that need to employ qualified technicians 
in accordance with the provisions of Paragraph 1 of Article 15 of the Act shall include the 
medical device the license holders, those who have completed the listing, and their authorized 
persons.  
Article 16 Medic al device firms that transfer from the original place to another municipal city, 
or county/city shall apply for dissolution and explain to the original competent authority that 
the reason for dissolution  is transfer, so the firm does not need to hand in it s medical device 
license for cancellation.  
Article 17 The so -called data referred to in Article 31 of the Act refers to documents and 
information that medical device firms need to submit to complete registration and market 
approval or listing in accordan ce with the provisions of regulations governing issuance of 
medical device license, listing of medical device and annual declaration.   
If the aforementioned data needs to be made available to the public in accordance with 
the provisions of Article 31 of th e Act or other rules, the methods are as follows:  
1. Publish the information in the Government Gazette or other government publications.  
2. Publish the information through government telecommunications network or on 
government websites.  
3. Other methods that allow the information to be made available to the public.  
Article 18 The so -called "smallest packaging unit for sale" referred to in Article 32 of the Act 
refers to the packaging sold directly to consumers or medical institutions.  
Article 19 In accordance with Article 33 of the Act, the content and publishing methods of 
labels, instructions, or packaging of medical devices shall meet the following rules:  
1. For domestically manufactured medical devices, the labels shall be primarily in 
traditional Chinese and any appended text in a foreign language shall be smaller than the 
Chinese. However, this does not apply to medical devices that are approved to be 
manufactured for export only.  
2. On the smallest packaging unit for sale, the name of th e product,  license number or 
listing number, name and address of the license holder or the person who completed the 
listing shall be in traditional Chinese. Manufacturing date, period of validity or expiration 
date shall be understood habitually.  
Article  20 For medical device firms that need to report in accordance with the provisions of 5 Paragraph 4 of Article 34 of the Act, the content of the report shall include name of the 
medical device firm, name of the medical device, model number of the product, license 
number or  listing number , date of report, contact person for the report, inventory, estimated 
time of available supply, reasons for the shortage in supply and other related information.  
Article 21 Medical device license holder or the  person who completed the listing shall submit 
the following document and information when they apply to publish or broadcast a medical 
device advertisement in accordance with the provisions of Article 41 of the Act:  
1. The application form for approval of m edical device advertisements.  
2. Photocopies of instructions and labels for approval : For Class 1 medical devices, 
photocopies of instructions, labels or packaging for the product  can be used with an 
affidavit stating the authenticity of the content.  
3. For advertisement that promotes product features that are not related to therapeutic effect,  
the documentary proof.  
4. Other documents and information designated by the central competent authority.  
Article 22 In the event that the medical device advertisem ent to be broadcasted or published 
include medical devices that belong to different license holders or different persons have 
completed the listing, medical device firms shall reach a consensus and authorize one of the 
license holders or persons who has co mpleted the listing to submit the application.  
Article 23 Medical device advertisements shall include the following items:  
1. Approved or listed product name;  
2. Name of the license holder or the person who completed the listing;  
3. Medical device license or listing number.  
4. Number of the medical device advertisement approval document.  
When the content of a medical device advertisement involves therapeutic effect, 
instructions, precautions, labels, package inserts , packaging or address of the firm, such 
content shall be limited to approved content of registration and market approval or listing. .  
Article 24 In any of the following situations, the application shall be disapproved:  
1. The content is identified as false , exaggerated, or misleading;  
2. The content fails to use fair, objective and appropriate basis for comparison to compare its 
effectiveness or  therapeutic effect  with other products.  
3. The content violates other laws and regulations or rules on medica l device advertisements.  
Article 25 If the medical device firm applying for approval of its medical device 
advertisements does not agree with the decision made regarding the application, the firm may 
file a complaint in writing with reasons to the origin al approving authority within 30 days 
starting from the following day on which the decision notice arrives, or file a administrative 
appeal according to the provisions of the Administrative Appeal Act.  
The aforementioned complaint shall be limited to once  only. If the applicant does not 
agree with the result, the applicant shall file an administrative appeal according to the 
provisions of the Administrative Appeal Act.  6 Article 26 In accordance with the provisions of Article 43 of the Act, those who wish to apply 
to extend the validity period for their medical device advertisement approval documents shall 
file an application for extension and a checklist with the original  approving authority.  
Article 27 The medical device license holders or those who completed the listing, according to 
the provisions of Paragraph 1 of Article 49 of the Act, shall use the electronic system 
designated by the central competent authority to report within 7 days from the day of 
discovery; when necessary, such report can be done in writing, through e -mail, facsimile or 
telephone.  
The aforementioned report shall include:  
1. Name and contact information of the medical device license holder or the p erson who 
completed the listing.  
2. Medical device license number or listing number; model number, batch or serial number, 
total quantity sold domestically and inventory.  
3. Claims and reasons that the medical device has caused or may cause harm to the health of 
human body.  
4. For those who have confirmed corrective and preventive measures for the aforementioned 
harm, the content of the measures and the dates to undertake and complete the measures.  
5. Other relevant information.  
If the firm has not yet confirmed t he corrective and preventive measures referred to in 
Subparagraph 4 of the preceding Paragraph at the time of reporting, the firm shall confirm 
within a reasonable period or within a given time period designated by the competent 
authority.  
Upon undertakin g the corrective and preventive measures, the medical device license 
holder or the person who completed the listing shall prepare a report on the result of corrective 
and preventive measures and such report shall be kept on file for future reference. The r eport 
shall include the following items:  
1. Confirmation of whether or not the harm or potential harm exists; if the harm or potential 
does exist, the reasons for the harm.  
2. Corrective and preventive measure undertaken, the implementation period and the 
outco mes.  
3. The date and method to publish advisory contents and target audience of advisory 
contents.  
Article 28 An informant may report violations to the competent authority by means of written 
communications, oral communications, email s or other methods. The report shall include the 
following information:  
1. The informant’s name, national identification number, contact information and address.  
2. The violator’s name and address, or in case of a business, the name and address of the 
company or  business as well as the representative’s name.  
3. The specifics of the violation, including the acts of violation, location, relevant 7 information or any leads that may help the investigation.  
If the informant is not able to verify the information specified  in Subparagraphs 2 and 3, 
the informant may leave it out of the report.  
The government agency that receives a violation report through oral communication 
shall produce a written record and confirm the specifics of the report with the informant.  
If the a gency that receives the report does not have jurisdiction over the matters of 
violation, the agency shall identify the appropriate jurisdictional authority, forward the report 
within seven days of the identification and notify the informant of the case tra nsfer.  
Article 29 The competent authority shall respond to the violation report as described in the 
preceding Article with thoroughness and timeliness, and notify the informant of the progress of 
the response within thirty days beginning from the day of receiving the report.  
Article 30 When a violation report helps the government discover defective medical devices, 
or firms manufacturing or importing medical devices without license or listing, a reward may 
be issued by the municipal or county/city compe tent authority according to the violation based 
on the point system below:  
1. Reports of the manufacture or import of medical devices without license or listing: 4 
points to 10 points.  
2. Reports of th e wholesale resale or transfer  of medical devices manufactured or imported 
without license or listing: 2 to 5 points.  
3. Reports of anyone sells, supplies, transports, stores, e ngaging in brokerage of, or display 
with intent to sell medical devices manufactured or imported without license or listing: 2 
to 3 points.  
4. Reports of the manufacture, import or sale of defective medical devices: 2 to 3 points.  
The monetary amount correlated with each point will be determined by the municipal  or 
county/city competent authority as it deems appropriate under the circumstances, and it shall 
also make budgetary allocations for that purpose.  
Article 31 In the event that the case of reported acts of violation receives a verdict of not 
guilty, or t he administrative sanction order is nullified or revoked for reasons not related to the 
validity of the report, the competent authority shall not ask to recover the monetary reward 
already paid to the informant according to the preceding Article.  
Article  32 Reports of following circumstance are not granted with reward:  
1. Anonymous information.  
2. The report is made with a forged name or identification or the report is false.  
3. No factual statement.  
4. The competent authority or other government agencies are alrea dy aware of the 
violation.  
Article 33 When a violation report referred to in Article 30 is jointly made with two or more 
people, all informants receive the reward. If two or more persons separately report a case and 
the particulars of the case are the sa me, the reward shall be issued to the first person to make 8 the report; if the order of reporting cannot be determined, the reward shall be divided equally 
among the persons who made reports.  
Article 34 The competent authority shall keep the information regarding an informant’s name, 
age, address, written communications, drawings, information, appearance, identification and 
any other identifiable characteristics confidential. People who engage in acts of disclosing 
such information are subject to punishment or disciplinary actions under the Personal 
Information Protection Act, the Criminal Code or other applicable laws and regulations.  
The violation reports, written records and other informatio n provided by an informant 
shall be stored as classified documents. Third parties are prohibited from access or copy of the 
record.  
Article 35 The competent authorities that accept violation reports may request the help of the 
local police to ensure the personal safety of an informant when necessary.  
When an informant is exposed to threats, intimidation and other dangers due to making 
the violation report, the competent authorities shall request the aid of the police to resolve the 
situation according to  the laws.  
Article 36 The Enforcement Rules come into force from the date of promulgation of the Act.  
 