Medical Device Quality Management System Regulations 
Chapter 1 General Provisions
Article 1
This set of regulations is established pursuant to Article 22 Paragraph 4 of the
Medical Device Act (hereafter referred as the Act).
Article 2
In  this  Part,  standards  related  to  the  facilities,  equipment,  organization  and
personnel, production, quality control, storage, distribution, handling of customer
complaints and other matters of manufacturers of medical devices are prescribed
with  reference  to  the  ISO  13485:  Medical  Devices  —  Quality  Management
Systems — Requirements for Regulatory Purposes published by the International
Standard Organization.
Article 3
The terms used in this Regulations are defined as follows:
(1)  Advisory  notice:  It  refers  to  supplementary  information  or  recommended
measures issued by the manufacturers, after delivery of medical devices, for the
usage, modification, recall,  destruction or other related matters of the medical
devices;
(2) Customer complaint: It means a message showing dissatisfaction in written,
electronic or oral forms related to the features, quality, usability, reliability, safety,
fuctionality or performance of a medical device on the market;
(3) Implantable medical device: It means a medical device intended to be totally or
partially  introduced  into  the  human  body  or  a  natural  orifice,  to  replace  an
epithelial surface or the surface of the eye, by surgical intervention, and which is
intended  to  remain  after  the  procedure  for  at  least  30  days,  and  can  only  be
removed by medical or surgical intervention;
(4) Post-marketing surveillance: It refers to the systematic collection and analysis
by the manufacturer of the actual user experience of the medical devices that have
been listed;
(5)  Product:  It  refers  to  the  output  of  the  operation  process  related  to  the
manufacturing of the medical devices, including service, software, hardware and
processing materials;
(6) Risk management: It refers to systematic application of management policies,
procedures, and practices on the analysis, evaluation, and control of risks;
(7) Sterilization barrier system: It refers to the minimum package that prevents
ingress of microorganisms and allow aseptic presentation of the product at the point
of use.
Chapter 2 Quality Management System
Article 4
The manufacturer shall document a quality management system and maintain its
effectiveness in accordance with the provisions of these Regulations 
The  manufacturer  shall  establish,  implement  and  maintain  the  requirements,
procedures, activities or arrangements set out in the quality management system:
1.To determine and implement the processes required for the quality management
system;2.To monitor the quality management system process based on risk assessment;
3.To determine the sequence and interaction of the implementation process of
quality management system.
Article 5
The manufacturer shall take the following measures on the quality management
system process;
1.To determine criteria and methods adopted to establish and maintain the quality
management system;
2.The acquisition of resources and information needed to establish and maintain
the quality management system;
3.The necessary actions to achieve the expected results of the quality management
system and to maintain the effectiveness of its processes;
4. The monitoring, analysis and necessary measurement of the quality management
system process;
5.  The  establishment  and  maintenance  of  necessary  records  in  order  to  prove
compliance with the Act and these Regulations.
Article 6
The formulation and changes of the foregoing process shall be carried out with the
impact assessment of the quality management system and the medical device to
ensure compliance with the requirements of the Act and these Regulations.
Article 7
The manufacturer shall implement monitoring on the part of outsourced services in
the  quality  management  system  process,  which  may  affect  the  product’s
compliance with the requirements.
The  manufacturer  shall  ensure  that  the  outsourcing  process  complies  with  the
requirements of these Regulations, the customers and other relevant regulations,
and shall adopt control measures commensurate with the risk of outsourcing and
the ability of the trustees to comply with the law, including the signing of a written
contract.
Article 8
The manufacturer shall establish and document the validation procedures for the
effectiveness  of  computer  software  in  the  quality  management  system.  The
software shall be validated prior to initial use; the same applies to the changes of
software or its applications, if necessary.
The specific methods and activities used for software validation and re-validation
shall be commensurate with the risk of use of the software.
The manufacturer shall keep record of the foregoing measures of validation and re-
validation.
Article 9
The  content  of  the  quality  management  system  document  shall  include  the
following matters:
1.Statement of quality policy and quality objectives;
2.The quality manual;
3.Procedures and records required by these Regulations;
4.Documents  and  records  developed  by  the  manufacturer  to  ensure  theeffectiveness of planning, operation and control of the quality management system
process;
5.Other documents required by central competent authorities.
Article 10
(The content of foregoing quality manual shall include the following items:)
The manufacturer shall establish a quality manual, and the content of which shall
include the following items:
1. The file structure used by the quality management system.
2.The scope of the quality management system and reasons of exclusions from
application or non-enforcement, if any;
3.The procedures established by the quality management system;
4.The interaction between quality management system processes.
Article 11
The manufacturer shall establish medical device file for each type or series of
medical devices as evidence that their manufacture complies with the provisions of
the Act and these Regulations.
The foregoing medical device file shall include the following content:
1.An overview of the medical device, its intended use or purpose, and labeling;
2.Product specifications;
3.Specifications or procedures for manufacturing, packaging, storage, handling and
distribution;
4.Measurement and monitoring procedures;
5.Installation requirements;
6.Service requirements.
The presentation of the foregoing content may be in the form of a document or an
index.
Article 12
The manufacturer shall control the documents used for the quality management
system.
The manufacturer shall establish control procedures in writing for the following
matters:
1.The review and approval of the documents before release and circulation; the
same applies to the revise;
2.The  identification  and  verification  of  the  serial  number  of  versions  and  the
history of revisions and status;
3.The availability of the documents in respective places;
4.The confirmation of document version and readability;
5. Ascertaining the validity of the necessary external original documents, and the
control of the distribution of the documents;
6. Prevention of damage or loss of documents;
7.Identification of void documents and preventive measures against misuse.
The revise mentioned as first subparagraph of foregoing paragraph shall ensure that
the changes to the documents are based on the review and approval by the offices
issuing the original approval or their designated offices with reference to relevant
background information.The manufacturer shall specify the period of keeping the void documents to ensure
the availability of the data of manufacturing and testing, which shall not be less
than the period specified in the relevant laws and regulations.
Article 13
The manufacturer shall establish and maintain a record sufficient enough to prove
compliance  with  these  Regulations.  Records  shall  remain  legible,  readily
identifiable and retrievable.
The manufacturer shall establish a documented procedure to define the controls
needed  for  the  identification,  storage,  protection,  retrieval,  retention  time  and
disposition of records.
The retention period of the record in the first paragraph shall be no less than the
validity period of the medical device and shall be no less than three years from the
date of release of the product by the manufacturer. Other laws and regulations, in
which a longer period is required, shall prevail.
The manufacturer shall formulate and implement protection measures for sensitive
health information in records in accordance with the provisions of the Personal
Data Protection Act.
Chapter 3 Management Responsibility
Article 14
The top management shall ensure the establishment, implementation and effective
maintenance of the quality management system, and shall provide evidence of
participation in the following matters:
1.Internal communication of customer needs and the importance of compliance
with laws and regulations.
2.Establishment of quality policies.
3.Establishment of quality objectives.
4.Management review of the quality management system.
5.The supply of resources required by the quality management system.
Article 15
The  top  management  shall  confirm  the  contents  which  mentioned  as  first
subparagraph of foregoing procedures that shall be complied with to satisfy the
demands, and shall ensure their implementation.
Article 16
The top management shall ensure the quality policies which mentioned as second
subparagraph of Article 14 is consistent with the establishment purposes of the
manufacturer, and its content includes the following matters:
1. Compliance with the requirements of the quality management system and the
commitment to maintain the effectiveness of the system;
2.The framework for establishing and reviewing quality objectives.
The suitability of the quality policy shall be reviewed and communicated within the
manufacturer's  organization  to  ensure  the  understanding  by  members  of  each
group.
Article 17
The  top  management  shall  ensure  that  all  levels  of  offices  complete  the
establishment of the quality objectives which mentioned as third subparagraph ofArticle 14.
The foregoing quality objectives shall be set on the basis of the quality policies,
and the content includes measurable items that shall be completed in order to
comply with regulations and product requirements.
Article 18
The top management shall confirm the following:
1.The  planning  of  the  quality  management  system  conforms  to  the  quality
objectives and the requirements of Articles 4 to 8;
2.The change of the quality management system shall keep the integrity of the
system.
Article 19
The top management shall specify in writing the duties and functions of the staffs
of its internal offices and have all the staffs of these offices informed of the same.
The top management shall bestow on the foregoing staffs whose jobs involve the
management, execution, and monitoring of quality the necessary power and the
independence to exercise the power, and shall be made the relationship among their
duties.
Article 20
The  quality  management  system  shall  have  one  person  as  the  management
representative,  who shall be assigned  by the  top management. The  duties and
functions of the aforementioned representative shall be stated in writing covering
the following matters:
1.Confirmation of the establishment of the quality management system process in
writing;
2.Submission  to  the  top  management  the  report  on  the  confirmation  of  the
effectiveness of the quality management system and the necessary improvement
measures;
3.Strengthening of the understanding among all the staffs of the manufacturer of
relevant laws and regulations and customer demands.
Article 21
The top management shall establish appropriate communication channels within
the  organization  to  ensure  that  matters  related  to  the  effectiveness  of  quality
management system are reflected.
Article 22
The  manufacturer  shall  establish,  in  writing,  the  management  level  review
procedure of the quality management system, and its content shall include the
evaluation  of  the  changes  or  advancement  of  the  quality  management  system
including quality policy and objectives.
The  top  management  level  shall  periodically  review  the  quality  management
system in accordance with the provisions of the preceding paragraph to ensure its
suitability, adequacy and effectiveness; its review shall be recorded and kept on
file.
Article 23
The  review  as  mentioned  in  the  preceding  Article  shall  include  the  following
matters:1.Feedback;
2.The handling customer complaints;
3.Reports to the competent central competent authority;
4. Results of internal or external audits;
5. Monitoring and measurement of the process and the results;
6.Monitoring and measurement of the products and the results;
7.Corrective measures;
8.Preventive measures;
9.Follow-up treatment of the conclusions of the previous review;
10. Changes that may affect the quality management system;
11. Recommendations for improvement;
12. Measures to cope with the amendments to the law and regulations.
Article 24
The record mentioned in Article 22 shall include the following matters:
1.Matters reviewed and their content;
2.Necessary improvement measures to maintain the suitability, appropriateness and
effectiveness of the quality management system and its processes;
3.Product improvement measures based on customer demands;
4.Measures to cope with the amendments of laws and regulations; 
5.Resource requirements for implementing the first three sub-paragraphs above.
Chapter 4 Resource Management
Article 25
The  manufacturer  shall  confirm  and  provide  the  necessary  resources  which
mentioned  as  fifth  subparagraph  of  Article  14  to  maintain  the  effective
implementation of the quality management system and comply with the laws and
regulations and the demands of customers.
Article 26
Members of the team engaged in work affecting product quality shall be properly
educated,  trained,  or  have  certain  skills  or  experience  to  ensure  their  job
competencies.
Article 27
The  manufacturer,  regarding  the  establishment  of  personnel’ capabilities,  the
provision of necessary training and the correct awareness of their responsibilities,
shall establish in writing the procedures for the following matters:
1.Identification of the competence of personnel engaged in work affecting product
quality.
2. The provision of necessary training or other measures to maintain personnel
capabilities.
3. Evaluation of the effectiveness of the training or measures in the preceding sub-
paragraphs.
4.The  insurance  of  the  awareness  of  the  relevance  and  importance  of  their
operation and the attainment of the quality objectives.
5.Record keeping in the forms of audio recording, photographs, video recording,
certificates and citations of the education, training, skills and experience of the
personnel.Article 28
In order to meet product requirements, the manufacturer shall specify in writing the
conditions of the infrastructure to avoid product confusion and disorderly handling.
The foregoing facilities shall include the following matters:
1.Buildings, working spaces and related facilities.
2.Hardware and software process equipment.
3.Support services such as transportation, communication or information systems.
If the maintenance on the aforementioned facilities affects the product quality, the
manufacturer shall determine the content and frequency of the implementation of
the maintenance activities; the implementation shall be recorded and kept on file.
These  provisions  apply  to  the  control,  monitoring,  and  measurement  of  work
environment mutatis mutandis.
Article 29
In order to ensure the consistency of product manufacturing, the manufacturer shall
specify  in  writing  the  requirements  on  working  environment  and  impose
monitoring and control on those which may adversely affect the product quality.
The foregoing requirements shall include the following:
1.The  health,  cleanliness  and  clothing  conditions  of  the  personnel  when  their
contact with the product or the operating environment can cause adverse effects on
the safety or performance of medical devices;
2.The  insurance  of  the  necessary  capabilities  of  temporary  personnel  working
under special environmental conditions or of their monitoring by those who possess
the capabilities.
Article 30
In order to prevent pollution caused by other products, working environment or
personnel, the manufacturer shall plan and establish in writing control measures for
contaminated or susceptible products.
The manufacturer  shall  establish  in writing  contamination  control measures of
microbes or particulates on sterile medical devices; the necessary sanitation shall
also be maintained in the process of assembly or packaging.
Chapter 5 Product Realization
Article 31
The manufacturer shall specify in writing the risk management process necessary
for product realization.
The  manufacturer  shall  plan  and  establish  the  processes  required  for  product
realization, and the plans shall comply with other process requirements of the
quality management system.
The content of the aforementioned planning shall be done in writing and specified
in the format acceptable with the operation mode of the manufacturer.The content
of planning shall include the following items, as appropriate:
1.Quality objectives and product requirements;
2.The establishment of necessary processes and documents, and the provision of
specific resources by individual products including the infrastructure and working
environment;
3.The  verification,  validation,  monitoring,  measurement,  inspection,  testing,handling, storage, distribution and source tracing measures of individual products,
and their acceptance criteria;
4.Records sufficient to prove that both the product realization process and the final
product meet the requirements.
The implementation of risk management mentioned in the first paragraph shall be
recorded and kept on file.
Article 32
The manufacturer shall confirm the following matters:
1.Requirement specified by the customers, which scope covers both before and
after delivery;
2.To meet known regulations or intended uses;
3. Applicable laws and regulations of the products;
4.The necessary training to be received by the users in order to ensure that the use
of medical devices meets the expected performance and safety;
5.Other matters.
Article 33
Before accepting product orders, the manufacturer shall review the requirements
related to the products and complete the confirmation of the following matters:
1.Specified requirements on products:
2.Handling of the difference between the content of the contract or order and that
as previously specified;
3.The compliance of laws and regulations;
4.Provision of user training courses;
5.The manufacturer’ possession of the ability to meet various requirements.
The results of the review and the measures to be taken related to the foregoing
review shall be recorded and kept on file.
If the customer does not state the requirement in writing, the manufacturer shall
ascertain it before accepting the order.
If there are changes occurring in the agreement between the manufacturer and the
customer,  the  manufacturer shall revise the relevant documents and inform its
relevant personnel of the changes.
Article 34
The  manufacturer  shall  specify  in  writing  the  following  matters  on  the
communication with customers;
1.Product information;
2.Customer inquiries, and processing and revision of contracts or orders;
3.Customer feedback including complaints;
4.Advisory notice.
The manufacturer shall apply for, notify or report matters specified in laws and
regulations to the competent authority.
Article 35
The manufacturer shall specify in writing the procedures and requirements for
product design and development. The content shall include the following:
1.The schedule of design and development, and the review, verification, validation
and design transfer measures as implemented in each phase.2. The duties and functions of the staffs at each phase of the procedure;
3. The method of tracing the design, development and output to its original items of
input;
4.The  resources  required  for  product  realization,  including  the  necessary
capabilities of the personnel.
The written documents mentioned in the preceding paragraph shall be kept on file
and updated in due course.
Article 36
The manufacturer shall review the appropriateness of the design and development
input items of the following matters, and verify, record and maintain the same:
1.The functions, features, usability and safety based on the intended use;
2.Applicable legal requirements and standards;
3.Output of applicable risk management assessment and measures resulted from
research;
4.Information available from similar product designs;
5.Other basic requirements for product and product realization process design and
development.
The matters in the preceding paragraphs shall be clear, complete and reasonable,
and shall be presented with methods for verification or validation.
Article 37
The product design, development and output shall comply with the following:
1.Conformity with the content approved in the first paragraph of the preceding
Article and shall be presented with methods of verification;
2.Provision of necessary information for the procurement, production and service;
3.Specification of the acceptance criteria of products;
4.Specification of the product characteristics that are essential for the product safe
and proper use.
The output mentioned in the preceding paragraph shall be subject to approval
before being released; its records shall be kept on file.
Article 38
The manufacturer shall meet Article 35 of the Act. to perform review on the design
and development based on the plans in writing to complete the following matters:
1.Evaluation of the compliance of the results of design and development with
requirement;
2.Identification and proposal of necessary actions.
Participants in the foregoing review shall include representatives of the design and
development departments, representatives of the departments affected by the design
and development results, and other technical personnel.
The results of the review and the necessary measures indicated therewith shall be
recorded and kept on file.
The content of the record as mentioned in the preceding paragraph shall clearly
record the subject of the review, the staff conducting the review and the date of
review.
Article 39
In order to ensure the consistency of design, development input and output, themanufacturer  shall  specify  in  writing  its  consistency  verification  plan  and
implement it accordingly.
The  content  of  the  foregoing  plan  shall  include  the  verification  methods,
acceptance criteria, necessary statistical techniques with rationale for sample size.
The verification mentioned in the first paragraph shall include the requirement of
connection or interface conforming with input and output consistency when and if
the intended use of the product involves the connection or interface with other
medical devices.
The verification results, conclusions and necessary measures proposed at the end of
the verification shall be recorded and kept on file.
Article 40
In order to ensure that the final product designed and developed meets the specific
application or expected requirements, the manufacturer shall establish in writing a
validation plan, which includes the validation methods, acceptance criteria, and the
necessary statistical techniques with rationale for sample size.
The  subject  of  validation  in  the  preceding  paragraph  shall  be  selected  from
representative products such as the first batch of production, and the reasons for
selection shall be recorded and kept on file.
The validation mentioned in the first paragraph shall include the requirement of
specific application or expected requirements when and if the intended use of the
product involves the connection or interface with other medical devices.
The validation mentioned in the first paragraph shall be completed before the
product is released. The verification result and the necessary measures proposed
shall be recorded and kept on file.
Article 41
The  manufacturer  shall  specify  in  writing  the  procedures  for  the  transfer  and
application  of  the  design  and  development  results  to  actual  manufacturing,  to
ensure that the manufacturing process and production capacity have been verified
to meet the requirements. The process and content of the transfer shall be recorded
and kept on file.
Article 42
The manufacturer shall specify in writing the control procedures on the changes of
the design and development to determine the degree of impact of the changes on
the functions, performance, usability, safety, regulatory requirements and intended
use of the medical devices.
The control mentioned in the preceding paragraph regarding the content of the
change shall be exercised in review, verification, necessary validation, approval
and be completed before the change takes place.
The review mentioned in the preceding paragraph shall include an assessment of
the impact of changes on product components, products in process or delivered,
risk management input or output, and the process of product realization.
The results of changes, the review and its related necessary measures shall be
recorded and and kept on file.
Article 43
The manufacturer should, for the design and development of each model or seriesof medical devices, establish and maintain a file. 
The foregoing file shall include or provide an index to records that can prove
compliance with the design and development requirements and the changes on the
design and development.
Article 44
The manufacturer shall establish in writing a validation procedure to ensure that the
purchased products meet its requirements.
The manufacturer shall formulate evaluation and selection criteria on the suppliers.
These are to be set based on the following considerations:
1.The ability of the supplier to provide products that meet the specifications of the
manufacturer;
2.The supplier's past performance;
3.The degree of influence of the products provided by suppliers on the quality of
medical devices;
4.Risks of medical devices to be manufactured.
The manufacturer shall plan mechanisms for the monitoring and re-evaluation of
the suppliers. The results of purchasing requirement compliance control are to be
used as a reference for re-evaluation.
The manufacturer shall take necessary measures if it finds that the supplier does not
meet the purchasing requirements.
The  evaluation,  selection,  monitoring,  re-evaluation  and  necessary  measures
mentioned in the first three items above shall be recorded and kept on file.
Article 45
The purchasing requirements mentioned in the preceding article shall include the
following matters and be made available for reference in writing or by other index
methods:
1.Product specifications;
2.Product acceptance, procedures, processes and equipment;
3.Qualification of supplier personnel;
4.Quality management system.
The manufacturer shall determine the adequacy of purchasing requirements before
approaching suppliers.
The manufacturer, when necessary, shall enter into agreement in writing that the
supplier shall notify the manufacturer in advance before implementing the changes
that may affect purchasing requirements.
The manufacturer shall maintain documents and records of purchasing information
required for traceability as set forth in these Regulations.
Article 46
The manufacturer shall formulate and implement inspections or other necessary
verification measures to ensure that the purchased products meet the purchasing
requirements.
The selection of the measures and content of the preceding paragraph shall refer to
the results of the risk assessment of the supplier and the medical device to be
manufactured. 
If there is a change in the purchased product, the manufacturer shall determine theimpact of the change on the medical device or its manufacturing process.
The measures mentioned in the first paragraph which can be implemented by the
manufacturer or its customers at the supplier's premises, shall be stated in the
purchasing  information  mentioned  in  the  preceding  Article,  with  the
implementation measures and the method of product release specified.
The implementation of the measures mentioned in the first paragraph shall be
recorded and and kept on file.
Article 47
The manufacturer shall plan the production and service processes, and implement,
monitor and control them to ensure that products meet specifications.
The content of production control in the preceding paragraph shall include, as
appropriate, the following matters:
1.Control procedures and methods for production stated in writing;
2.Validation of the suitability of infrastructure;
3.Implementation  of  monitoring  and  measurement  on  process  parameters  and
product characteristics;
4.Confirmation of the integrity of the equipment implementing the monitoring and
measurement stated in the preceding subparagraph;
5.Implementation of labeling and packaging operations.
6.Implementation of product release, delivery and post-delivery activities.
The manufacturer shall establish and maintain a production control record for each
batch (piece) of medical devices, and the content of which shall include the scope
of traceability set out in these Regulations, as well as the amount of production and
distribution. The record shall be verified and approved.
Article 48
The manufacturer, under any of the following circumstances, shall formulate in
writing the requirements for product cleaning or pollution control:
1.The product shall be cleaned by the manufacturer before sterilization or use.
2.The product is supplied in a non-sterilized state, but the cleaning process is
completed before sterilization or use.
3. The product cannot be cleaned before sterilization or use, but its cleanliness has
a significant impact on use.
4. The product does not need to be sterilized for use, but its cleanliness has a
significant impact on use.
5. The pharmaceuticals used in the manufacturing process must be removed from
the product.
Subparagraphs 1 and 2 of the preceding paragraph do not apply the provisions of
Article 29 before cleaning.
Article 49
The  manufacturer  should,  when  necessary,  formulate  in  writing  the  verifiable
installation requirements and acceptance criteria for specific medical devices. 
If, upon the request of the buyer, the manufacturer agrees for the medical device to
be installed by a third party other than the buyer and its authorized agent, the
manufacturer shall provide to the third party the documents of the matters and
criteria set out in the preceding paragraph.The manufacturer shall record and maintain the records of the installation by itself
or its authorized agents.
Article 50
If there are specific specifications for the after-sales service of medical devices, the
manufacturer  shall  formulate,  in  writing,  the  service  procedures,  the  reference
measurement methods or other information for implementation and verification.
For the aforementioned service, the manufacturer or its authorized agent shall
record and keep it on file.
The manufacturer shall analyze the foregoing records to determine whether there
are any complaints that shall be handled, and if necessary, include them in the
reference for product improvement.
Article 51
The manufacturer shall keep a record of the sterilization process parameters of each
sterilization batch.
The content of the foregoing record shall be traceable to each production batch of
the medical device.
Article 52
The deficiencies of production or service of medical devices, which cannot be
revealed without being used or received, shall be validated by the manufacturer of
the process of production or service.
The procedure of validation mentioned in the preceding paragraph to prove that the
production or service is in accordance with its planned schedule shall be set it in
writing, and its content includes the following matters:
1.Review standards and approval procedures;
2.The required equipment and their specifications, and the qualifications of the
implementing personnel;
3.Specific methods, procedures and acceptance criteria adopted;
4.The statistical techniques with rationale for sample size;
5.The requirements for record confirmation in accordance with Article 13;
6.Revalidation and its criteria;
7.Approval of changes of the validation procedures;
The manufacturer shall establish procedures in writing to validate the computer
software  they use  before  production  or  service  provision;  the  same  applies to
changes  adopted  in  their  software.  The  choice  of  software  validation  and
revalidation methods shall take into account the impact of software on product
specification compliance.
The results of the foregoing validation and revalidation, the conclusions obtained
based on the results, and necessary actions for subsequent implementation shall be
recorded and kept on file.
Article 53
The manufacturer shall establish in writing the procedures for validation of the
sterilization  process  and  the  sterile  barrier  system.  The  scope  of  application
includes the product itself, and the same applies when the manufacturing process is
changed.
The results of validation mentioned in the preceding paragraph, their conclusionsand the necessary follow-up measures shall be recorded and kept on file.
Article 54
The  manufacturer  shall  establish  in  writing  the  procedures  and  methods  for
identifying products in the product realization process to ensure that the returned
product is separated from other products.
The manufacturer shall identify product compliance during the process of product
realization.  The  process  includes  production,  storage,  installation,  and  service
processes so as to ensure that only products that pass specific inspections, tests, or
approvals are released, used, or installed.
The  manufacturer  shall  establish  in  writing  a  single  identification  system  for
medical devices with certain risk class as announced in accordance with the first
paragraph, Article 19 of the Act .
Article 55
The manufacturer should, within the scope and record content stipulated by laws
and regulations, set in writing the traceability procedures of products.
Article 56
Where  the  record mentioned  in the  preceding  Article  relates to  traceability  of
implantable medical devices, it shall include all parts, materials and production
environmental  conditions  that  may  cause  non-compliance  with  safety  and
performance requirements.
The  manufacturer  of  the  product  mentioned  in  the  preceding  paragraph  shall
require the logistics and distributor of its product to keep the logistic or sales
records; and whereas the product is delivered by parcel, the record of the voucher
of the name and address of the consignee shall be kept by the manufacturer.
Article 57
The manufacturer shall identify, verify, protect and safeguard the tools, storage
equipment,  transportation  vehicles,  development  designs,  materials,  or  other
tangible or intangible assets provided by the customer for use or forming part of the
product.
If  the  asset  in  the  preceding  paragraph  is  lost,  damaged  or  unusable,  the
manufacturer shall notify the customer and produce a record and keep on file.
Article 58
The manufacturer shall establish in writing protection procedures to ensure that the
product specifications are not affected by the processing, storage, handling and
distribution process.
In the procedures mentioned in the preceding paragraph, in order to prevent the
product from being exposed to the anticipated state or hazard, which lead to the
risks of alteration, contamination or damage, the manufacturer shall implement the
following matters:
1.Designing and constructing suitable packaging and shipping containers.
2.Providing special additional conditions in writing, if the package or container in
the preceding subparagraph  fails to provide adequate  protection under specific
circumstances, and the conditions shall be under control and listed in records.
The above two provisions also apply to the protection of product components.
Article 59The manufacturer shall plan the monitoring and measurement operations to fully
certify the product conformity and shall have the relevant equipment necessary to
perform the operations.
The procedure mentioned in the preceding paragraph shall be specified in writing
by the manufacturer.
The use of the measurement equipment mentioned in the first paragraph shall
comply with the following requirements:
1.Calibration  or  verification  with  clear  international  or  national  measurement
standards before initial use; where there are no clear standards, the basis used for
calibration or verification shall be recorded. The same shall be done regularly after
the equipment is commissioned;
2.After  calibration  and  verification,  it  make  necessary  adjustments  and
readjustments for avoiding adjustments that cause invalidated measurement results;
3.The calibration status shall be identified;
4. Taking precautionary measures to avoid damage  or deterioration in case  of
handling, maintenance or storage.
The manufacturer shall perform the calibration or verification in accordance with
the provision of the second paragraph, and record and keep the results.
If inconformity is found on the equipment as mentioned in the first paragraph, the
manufacturer shall evaluate the effectiveness of the measurement of its output and
record it. Appropriate measures shall be taken for the affected products.
The manufacturer shall establish in writing a validation procedure for the suitability
of the computer software for monitoring and measurement purposes, and complete
the confirmation before the software is used, or after actual use, or upon changes
made in the software.
The  validation  and  re-validation  of  the  software  mentioned  in  the  preceding
paragraph shall be based on the risks of using the software and exercised with
appropriate methods and activities. The results, conclusions reached and necessary
follow-up actions shall be recorded and kept on file.
The risks mentioned in the preceding paragraph include the effects of the capability
of the medical device to meet its intended use.
Chapter 6 Measurement, Analysis and Improvement
Article 60
The manufacturer shall plan and implement monitoring, measurement, analysis and
improvement processes to ensure the conformity of products and the conformity
and effectiveness of quality systems. 
The  foregoing  planning  shall  include  validation  of  the  appropriate  methods
including statistical techniques and the scope of application.
Article 61
In  order  to  evaluate  the  effectiveness  of  the  quality  management  system,  the
manufacturer shall gather and monitor information on compliance with customer
requirements.
The manufacturer shall formulate in writing the methods for collecting and using
the information mentioned in the preceding paragraph.
Article 62The  manufacturer  shall  formulate  in  writing  procedures  for  receiving  and
processing  the  information  as  mentioned  in  the  preceding  article.  Specific
provisions of laws and regulations, if available, shall prevail.
The foregoing procedures shall include the aggregation of production and post-
production  information;  the  consolidated  information  shall  be  used  by  the
manufacturer  as  a  reference  for  risk  management,  monitoring  and  product
conformity maintenance, and the process of product realization and improvement.
Article 63
The  manufacturer  shall  formulate  in  writing  the  procedures  and  deadlines  for
complaints handling, and the content of the procedures shall include the following
matters:
1.Acceptance and record of the cases of complaint;
2. Evaluation if the case is established;
3. Investigation of the incident;
4.Matters and methods of statutory notification;
5.Treatment of the products based on investigation results;
6. Decisions on subsequent correction and content of corrective actions.
If the complaint case referred to in the preceding paragraph is found not caused by
the manufacturer, the manufacturer shall provide the content of the complaint and
the  appropriate  information  obtained  from  the  investigation  to  the  relevant
stakeholders.
The record mentioned in the first paragraph shall include the matters in all the sub-
paragraphs in the same paragraph and the reasons for not having exercised incident
investigation. The record shall be kept on file.
Article 64
The manufacturer shall handle the reporting of adverse events of Paragraph 1 of
Article 48 of the Act, the reporting and the undertaking of corrective and preventive
measures of Article 49 of the Act, the notifying and recalling within a definite time
of Paragraph 1 of Article 58 of the Act, and formulate the procedures for operation.
The notification, corrective and preventive measures, recall as mentioned in the
preceding paragraph shall be recorded and kept on file.
Article 65
The manufacturer shall perform internal audits regularly to ensure the effectiveness
of the quality management system and its compliance with laws and regulations.
The manufacturer shall formulate the procedures for the audit as mentioned in the
preceding paragraph, which shall include the division of powers and requirements
related to the planning, execution, recording and reporting of audit results.
Article 66
With regard to the content of the audit plan mentioned in the preceding Article, the
manufacturer shall formulate it while taking into account the subject, content and
location,  as  well  as  the  relative  importance  of  the  processes  in  the  quality
management system and the results of previous audits.
The content of the preceding paragraph shall include the audit criteria, scope,
frequency, method and records; the auditor shall not audit the work of their own
duties.Article 67
The process, place and results of the audit shall be thoroughly recorded and kept on
file.
The management of the auditee shall propose corrective measures for the non-
compliance of the audit results as mentioned in the preceding paragraph and correct
them in time to ensure that the non-compliances and their causes are removed.
The manufacturer shall submit verification reports on the content and results of the
implementation of corrective measures.
Article 68
The manufacturer shall adopt appropriate methods to monitor and measure the
various processes of the quality management system.
The  manufacturer  shall,  if  the  objectives  of  processes  as  mentioned  in  the
preceding paragraph are not achieved, propose corrective measures and implement
the same to ensure product compliance.
Article 69
The manufacturer shall, during the product realization process, formulate in writing
the monitoring and measurement procedures at appropriate stages based on the
characteristics of the product, to verify the conformity of the product.
The products shall not be released unless verified in the foregoing procedure.
The execution of the procedure mentioned in the first paragraph shall be recorded,
and its contents shall include the following matters:
1.The name of the person authorized to give permit of the release;
2. Evidence that the acceptance criteria are met;
3.The name of the test equipment, if any equipment is used; 
4.The names of the inspectors or testers of implantable medical devices, if the
devices are used.
Article 70
The  manufacturer  shall  identify  and  control  products  that  do  not  meet  the
requirements to prevent unintended use or delivery.
In order to meet the requirements of the preceding paragraph, the manufacturer
shall  formulate  in  writing  the  definition  of  rights  and  responsibilities  in  the
procedures of identification, recording, segmentation, evaluation, discarding, etc. of
the products that do not meet the requirements of the original manufacturer.
The evaluation mentioned in the preceding paragraph shall include the decision to
initiate an investigation and to notify the relevant external authorities.
The  manufacturer  shall  record  the  non-conformity  as  mentioned  in  the  first
paragraph, the reasons for subsequent evaluation and investigation, and reasons for
decisions made, and keep the record in file.
Article 71
The  manufacturer  shall  impose  the  following  treatments  separately  or
simultaneously on unqualified products:
1. Measures to remove non-conformities; 
2.Measures to prevent the use or application of substandard products mistakenly
for their intended purposes;
3.Authorization of the use, release or acceptance of the product under concession.The manufacturer adopting the treatment method in the third sub-paragraph of the
preceding paragraph may do so only with sufficient valid reasons to meet the
requirements of the second subparagraph of paragraph 1, Article 36, and receive the
approval of the responsible personnel. The name and title of the person giving the
approval shall be recorded and kept on file.
Article 72
If  any  non-conformity  is  found  after  delivery,  the  manufacturer  shall  take
appropriate measures with regard to its impact or potential impact, and shall be
recorded and kept on file.
The manufacturer shall, in accordance with laws and regulations, formulate in
writing the procedure for issuing advisory notices to external parties, and shall
follow the said procedure.
The  issuance  of  advisory  notices  shall  be  recorded  and  maintained  by  the
manufacturer.
Article 73
The manufacturer shall, in light of the possible effects of product reprocessing,
formulate in writing appropriate rework procedures and have the procedures under
review in accordance with the original procedure.
Reprocessed  products  shall  be  verified  to  ensure  compliance  with  acceptance
criteria and laws and regulations.
The implementation of rework shall be recorded and kept on file.
Article 74
The manufacturer shall formulate in writing the items and analysis procedures of
data collection to prove the adequacy, suitability and effectiveness of the quality
management system.
The procedure mentioned in the preceding paragraph shall include implementation
methods including the use of statistical techniques and selection of their scope of
application.
The data of analysis mentioned in the first paragraph shall include the results from
monitoring and measurement. The analysis shall provide at least the following
information:
1.Customers'  opinions,  comments  and  expressions  on  the  product,  service  or
complaint handling process;
2.The compliance of product specifications;
3. The characteristics and trends of changes of the processes and products, and the
timing of intervention for appropriate improvements;
4.Evaluation on the raw materials or services provided by suppliers;
5.Result of the audit on the manufacturer;
6.Evaluation of service reports, when necessary.
If the  quality  management  system  is found to be unsuitable,  inappropriate, or
ineffective through the analysis made in the preceding paragraph, the manufacturer
shall take the analysis results as basis of improvements following the provisions of
Articles 75, 76, and 77.
The aforementioned results of analysis shall be recorded and kept on file.
Article 75The  manufacturer  shall,  based  on  its  quality  policies  and  objectives,  make
necessary  changes  to  ensure  and  maintain  the  adequacy,  suitability  and
effectiveness of the quality management system, and the safety and performance of
the medical device.
The changes mentioned in the preceding paragraph shall be based on the audit
results, post-marketing surveillance, data analysis, and corrective and preventive
actions, and shall be implemented after the review and validation of the content of
changes by the management.
Article 76
The  manufacturer  shall  take  corrective  actions  to  remove  the  cause  of  non-
conformity and prevent its recurrence.
The implementation of the corrective actions mentioned in the preceding paragraph
shall  not  be  delayed  for  no  reason,  and  the  content  of  the  actions  shall  be
formulated based on the degree of influence of the non-conformity.
In order to implement the corrective action mentioned in the first paragraph, the
manufacturer  shall  formulate  in  writing  the  procedures  for  completing  the
following items:
1.Review of non-conformities including customer complaints.
2. Judgment of reasons for non-conformities.
3. Evaluation of the adoption of corrective actions.
4. The planning, formulation and implementation of corrective actions, and the
necessary updates of quality system documents.
5. Verification that corrective actions do not conflict with laws and regulations, and
do not degrade the safety and performance of the medical device.
6.Review of the implementation of corrective actions and their effectiveness.
With regard to the formulation of corrective actions, the manufacturer shall record
and keep the results of investigations it has performed on non-conformities and the
implementation of corrective actions.
Article 77
The manufacturer shall take preventive actions to remove possible causes of non-
conformity and prevent its occurrence.
The aforementioned content of the preventive actions shall be based on the degree
of impact of potential non-conformities.
In  order  to  implement  the  preventive  actions  in  the  first  paragraph,  the
manufacturer  shall  formulate  in  writing  the  procedures  for  completing  the
following items:
1.Judgment of potential non-conformities and their possible causes.
2.Evaluation of the adoption of preventive measures.
3.The planning, formulation and implementation of preventive actions, and the
necessary updating of quality system documents.
4.  Verification  that  the  preventive  actions  are  not  in  conflict  with  laws  and
regulations, and do not degrade the safety and performance of medical equipment;
5.Review of the implementation of preventive actions and their effectiveness.
In order to determine preventive actions, the manufacturer shall record and keep on
file  the  results  of  investigations  of  potential  non-conformities  and  theimplementation of preventive actions.
Chapter 7 Essential Mode
Article 78
The manufacturers engaged in producing only the items as listed in Annex, shall
establish medical device file according to each type or device or series of devices.
Each  manufacturer  shall  also  implement  procedures  for  control  of  records,
complaint handling as well as corrective and preventive actions.
The manufacturer mentioned in the preceding paragraph, may not be subject to
other provisions of this Part of these Regulations, except for the provisions of
Article 11, Article 12, Article 13, Article 47, Article 55, Article 63, Article 64,
Article 69, Article 76 and Article 77.
Article 79
The Regulations shall be implemented from May 1st, 2021.Annex
The manufacturing of the following devices, which need to be sterilized, shall comply with Chapters
2 to 6.
ACLINICAL  CHEMISTRY  AND  CLINICAL  TOXICOLOGY
DEVICES (Devices with measurement function are excluded)
Classification
NumberDevice Name Class
A.1030Alanine amino transferase (ALT/SGPT) test system 1
A.1040Aldolase test system 1
A.1060Delta-aminolevulinic acid test system 1
A.1065Ammonia test system 1
A.1075Androstenedione test system 1
A.1080Androsterone test system 1
A.1095Ascorbic acid test system 1
A.1113Bilirubin (total and unbound) in the neonate test system 1
A.1115Urinary bilirubin and its conjugates (nonquantitative) test system 1
A.1130Blood volume test system 1
A.1135C-peptides of proinsulin test system 1
A.1165Catecholamines (total) test system 1
A.1175Cholesterol (total) test system 1
A.1180Chymotrypsin test system 1
A.1185Compound S (11-deoxycortisol) test system 1
A.1190Copper test system 1
A.1195Corticoids test system 1
A.1200Corticosterone test system 1
A.1210Creatine test system 1
A.1240Cystine test system 1
A.1245Dehydroepiandrosterone (free and sulfate) test system 1
A.1250Deoxycorticosterone test system 1
A.12552,3-Diphosphoglyceric acid test system 1
A.1260Estradiol test system 1
A.1265Estriol test system 1
A.1270Estrogens (total, in pregnancy) test system 1
A.1275Estrogens (total, nonpregnancy) test system 1
A.1280Estrone test system 1
A.1285Etiocholanolone test system 1
A.1290Fatty acids test system 1
A.1300Follicle-stimulating hormone test system 1A.1305Formiminoglutamic acid (FIGLU) test system 1
A.1310Galactose test system 1
A.1320Gastric acidity test system 1
A.1325Gastrin test system 1
A.1330Globulin test system 1
A.1335Glucagon test system 1
A.1360Gamma-glutamyl transpeptidase and isoenzymes test system 1
A.1365Glutathione test system 1
A.1370Human growth hormone test system 1
A.1375Histidine test system 1
A.1380Hydroxybutyric dehydrogenase test system 1
A.138517-Hydroxycorticosteroids (17-ketogenic steroids) test system 1
A.13905-Hydroxyindole acetic acid/serotonin test system 1
A.139517-Hydroxyprogesterone test system 1
A.1400Hydroxyproline test system 1
A.1405Immunoreactive insulin test system 1
A.1410Iron (non-heme) test system 1
A.1415Iron-binding capacity test system 1
A.1420Isocitric dehydrogenase test system 1
A.143017-Ketosteroids test system 1
A.1435Ketones (nonquantitative) test system 1
A.1440Lactate dehydrogenase test system 1
A.1450Lactic acid test system 1
A.1460Leucine aminopeptidase test system 1
A.1465Lipase test system 1
A.1470Lipid (total) test system 1
A.1475Lipoprotein test system 1
A.1485Luteinizing hormone test system 1
A.1490Lysozyme (muramidase) test system 1
A.1495Magnesium test system 1
A.1500Malic dehydrogenase test system 1
A.1505Mucopolysaccharides (nonquantitative) test system 1
A.1510Nitrite (nonquantitative) test system 1
A.1515Nitrogen (amino-nitrogen) test system 1
A.15205'-Nucleotidase test system 1
A.1530Plasma oncometry test system 1
A.1535Ornithine carbamyl transferase test system 1
A.1540Osmolality test system 1A.1542Oxalate test system 1
A.1550Urinary pH (nonquantitative) test system 1
A.1560Urinary phenylketones (nonquantitative) test system 1
A.15656-Phosphogluconate dehydrogenase test system 1
A.1570Phosphohexose isomerase test system 1
A.1575Phospholipid test system 1
A.1580Phosphorus (inorganic) test system 1
A.1590Porphobilinogen test system 1
A.1595Porphyrins test system 1
A.1605Pregnanediol test system 1
A.1610Pregnanetriol test system 1
A.1615Pregnenolone test system 1
A.1620Progesterone test system 1
A.1625Prolactin (lactogen) test system 1
A.1630Protein (fractionation) test system 1
A.1635Total protein test system 1
A.1640Protein-bound iodine test system 1
A.1645Urinary protein or albumin (nonquantitative) test system 1
A.1650Pyruvate kinase test system 1
A.1655Pyruvic acid test system 1
A.1660Quality control material (assayed and unassayed) 1
A.1670Sorbitol dehydrogenase test system 1
A.1680Testosterone test system 1
A.1705Triglyceride test system 1
A.1710Total triiodothyronine test system 1
A.1715Triiodothyronine uptake test system 1
A.1720Triose phosphate isomerase test system 1
A.1725Trypsin test system 1
A.1730Free tyrosine test system 1
A.1775Uric acid test system 1
A.1780Urinary calculi (stones) test system 1
A.1785Urinary urobilinogen (nonquantitative) test system 1
A.1790Uroporphyrin test system 1
A.1795Vanilmandelic acid test system 1
A.1805Vitamin A test system 1
A.1815Vitamin E test system 1
A.1820Xylose test system 1
A.2270Thin-layer chromatography system for clinical use 1
A.3050Breath-alcohol test system 1A.3110Antimony test system 1
A.3120Arsenic test system 1
A.3220Carbon monoxide test system 1
A.3240Cholinesterase test system 1
A.3600Mercury test system 1
A.3750Quinine test system 1
A.3850Sulfonamide test system 1
BHEMATOLOGY AND PATHOLOGY DEVICES
(Devices with measurement function are excluded)
Classification
NumberDevice Name Class
B.0002Blood component extractor 1
B.1850Dye and chemical solution stains 1
B.1860Immunohistochemistry reagents and kits 1
B.2220Synthetic cell and tissue culture media and components 1
B.2260Chromosome culture kit 1
B.2280Cultured animal and human cells 1
B.2360Mycoplasma detection media and components 1
B.2875Balanced salt solutions or formulations 1
B.4020Analyte specific reagents 1
B.4400Enzyme preparations 1
B.5800Automated sedimentation rate device 1
B.6100Bleeding time device 1
B.6150Capillary blood collection tube 1
B.6160Manual blood cell counting device 1
B.6400Hematocrit measuring device 1
B.6600Osmotic fragility test 1
B.6700Erythrocyte sedimentation rate test 1
B.7040Adenosine triphosphate release assay 1
B.7660Leukocyte alkaline phosphatase test 1
B.7675Leukocyte peroxidase test 1
B.7900Thromboplastin generation test 1
B.8200Blood cell diluent 1
B.8500Lymphocyte separation medium 1
B.8540Red cell lysing reagent 1
B.8950Russell viper venom reagent 1
B.9050Blood bank supplies 1
B.9125Vacuum-assisted blood collection system 1B.9225Cell-freezing apparatus and reagents for in vitro diagnostic use 1
B.9320Copper sulfate solution for specific gravity determinations 1
B.9550Lectins and protectins 1
B.9575Environmental chamber for storage of platelet concentrate 1
B.9600Potentiating media for in vitro diagnostic use 1
B.9700Blood storage refrigerator and blood storage freezer 1
B.9750Heat-sealing device 1
CIMMUNOLOGY AND MICROBIOLOGY DEVICES 
(Devices with measurement function are excluded)
Classification
NumberDevice Name Class
C.0003Helicobacter spp. serological reagents 1
C.2160Coagulase plasma 1
C.2300Multipurpose culture medium 1
C.2320Differential culture medium 1
C.2330Enriched culture medium 1
C.2350Microbiological assay culture medium 1
C.2360Selective culture medium 1
C.2390Transport culture medium 1
C.2450Supplement for culture media 1
C.2480Quality control kit for culture media 1
C.2500Microtiter diluting and dispensing device 1
C.2580Gas-generating device 1
C.2600Wood's fluorescent lamp 1
C.2660Microorganism differentiation and identification device 1
C.2900Microbiological specimen collection and transport device 1
C.3010Acinetobacter calcoaceticus serological reagents 1
C.3020Adenovirus serological reagents 1
C.3035Arizona spp.serological reagents 1
C.3040Aspergillus spp. serological reagents 1
C.3060Blastomyces dermatitidis serological reagents 1
C.3065Bordetella spp. serological reagents 1
C.3085Brucella spp. serological reagents 1
C.3110Campylobacter fetus serological reagents 1
C.3120Chlamydia serological reagents 1
C.3125Citrobacter spp.serological reagents 1
C.3135Coccidioides immitis serological reagents 1C.3140Corynebacterium spp.serological reagents 1
C.3145Coxsackievirus serological reagents 1
C.3165Cryptococcus neoformans serological reagents 1
C.3200Echinococcus spp. serological reagents 1
C.3205Echovirus serological reagents 1
C.3220Entamoeba histolytica serological reagents 1
C.3235Epstein-Barr virus serological reagents 1
C.3240Equine encephalomyelitis virus serological reagents 1
C.3250Erysipelothrix rhusiopathiae serological reagents 1
C.3255Escherichia coli serological reagents 1
C.3270Flavobacterium spp. serological reagents 1
C.3280Francisella tularensis serological reagents 1
C.3300Haemophilus spp. serological reagents 1
C.3320Histoplasma capsulatum serological ragents 1
C.3330Influenza virus serological reagents 1
C.3340Klebsiella spp. serological reagents 1
C.3350Leptospira spp. serological reagents 1
C.3355Listeria spp. serological reagents 1
C.3360Lymphocytic chorimeningitis virus serological reagents 1
C.3370Mycobacterium tuberculosis immunofluorescent  reagents 1
C.3375Mycoplasma spp. serological reagents 1
C.3380Mumps virus serological reagents 1
C.3400Parainfluenza virus serological reagents 1
C.3405Poliovirus serological reagents 1
C.3410Proteus spp. (Weil-Felix) serological reagents 1
C.3415Pseudomonas spp. serological reagents 1
C.3470Reovirus serological reagents 1
C.3480Respiratory syncytial virus serological reagents 1
C.3490Rhinovirus serological reagents 1
C.3500Rickettsia serological reagents 1
C.3520Rubeola (measles) virus serological reagents 1
C.3550Salmonella spp. serological reagents 1
C.3600Schistosoma spp. serological reagents 1
C.3630Serratia spp. serological reagents 1
C.3660Shigella spp.serological reagents 1
C.3680Sporothrix schenckii serological reagents 1
C.3700Staphylococcus aureus serological reagents 1
C.3720Streptococcus spp. exoenzyme reagents 1
C.3740Streptococcus spp. serological reagents 1C.3850Trichinella spiralis serological reagents 1
C.3870Trypanosoma spp. serological reagents 1
C.3930Vibrio cholerae serological reagents 1
C.4100Complement reagent 1
C.5040Albumin immunological test system 1
C.5060Prealbumin immunological test system 1
C.5065Human allotypic marker immunological test system 1
C.5160Beta-globulin immunological test system 1
C.5170Breast milk immunological test system 1
C.5200Carbonic anhydrase B and C immunological test system 1
C.5220Cohn fraction II immunological test system 1
C.5230Colostrum immunological test system 1
C.5320Properdin factor B immunological test system 1
C.5330Factor XIII, A, S, immunological test system 1
C.5360Cohn fraction IV immunological test system 1
C.5370Cohn fraction V immunological test system 1
C.5380Free secretory component immunological test system 1
C.5400Alpha-globulin immunological test system 1
C.5420Alpha-1-glycoproteins immunological test system 1
C.5425Alpha-2-glycoproteins immunological test system 1
C.5430Beta-2-glycoprotein I immunological test system 1
C.5440Beta-2-glycoprotein III immunological test system 1
C.5460Haptoglobin immunological test system 1
C.5490Hemopexin immunological test system 1
C.5520Immunoglobulin G (Fab fragment specific) immunological test system 1
C.5530Immunoglobulin G (Fc fragment specific) immunological test system 1
C.5540Immunoglobulin G (Fd fragment specific) immunological test system 1
C.5560Lactic dehydrogenase immunological test system 1
C.5570Lactoferrin immunological test system 1
C.5590Lipoprotein X immunological test system 1
C.5700Whole human plasma or serum immunological test system 1
C.5715Plasminogen immunological test system 1
C.5735Prothrombin immunological test system 1
C.5765Retinol-binding protein immunological test system 1
C.5860Total spinal fluid immunological test system 1
C.5890Inter-alpha trypsin inhibitor immunological test system 1
DANESTHESIOLOGY DEVICESClassification
NumberClassification Name Class
D.1100Arterial blood sampling kit 1
D.1575Gas collection vessel 1
D.1910Esophageal stethoscope 1
D.1930Stethoscope head 1
D.5100Nasopharyngeal airway 1
D.5110Oropharyngeal airway 1
D.5220Blow bottle 1
D.5240Anesthesia breathing circuit 1
D.5280Breathing tube support 1
D.5300Carbon dioxide absorbent 1
D.5310Carbon dioxide absorber 1
D.5320Reservoir bag 1
D.5340Nasal oxygen cannula 1
D.5350Nasal oxygen catheter 1
D.5375Heat and moisture condenser (artificial nose) 1
D.5460Therapeutic humidifier for home use 1
D.5530Flexible laryngoscope 1
D.5540Rigid laryngoscope 1
D.5550Anesthetic gas mask 1
D.5560Gas mask head strap 1
D.5570Nonrebreathing mask 1
D.5580Oxygen mask 1
D.5590Scavenging mask 1
D.5600Venturi mask 1
D.5620Breathing mouthpiece 1
D.5640Medicinal nonventilatory nebulizer (atomizer) 1
D.5675Rebreathing device 1
D.5700Nonpowered oxygen tent 1
D.5770Tracheal tube fixation device 1
D.5780Tube introduction forceps 1
D.5790Tracheal tube stylet 1
D.5810Airway connector 1
D.5860Pressure tubing and accessories 1
D.5975Ventilator tubing 1
D.5995Tee drain (water trap) 1
D.6810Tracheobronchial suction catheter 1
D.6885Medical gas yoke assembly 1ECARDIOV ASCULAR DEVICES
Classification
NumberClassification Name Class
E.1875Stethoscope 1
E.3650Pacemaker polymeric mesh bag 1
E.3730Pacemaker service tools 1
E.3935Prosthetic heart valve holder 1
E.4200Cardiopulmonary bypass accessory equipment 1
E.4500Cardiovascular surgical instruments 1
FDENTAL DEVICES
Classification
NumberClassification Name Class
F.0001Retraction cord 1
F.1730Electrode gel for pulp tester 1
F.1820Dental x-ray exposure alignment device 1
F.1840Dental x-ray position indicating device 1
F.1850Lead-lined position indicator 1
F.2050Dental sonography device 1
F.2060Jaw tracking device 1
F.3100Dental amalgamator 1
F.3110Dental amalgam capsule 1
F.3130Preformed anchor 1
F.3140Resin applicator 1
F.3165Precision attachment 1
F.3240Dental bur 1
F.3275Dental cement 1
F.3285Preformed clasp 1
F.3330Preformed crown 1
F.3350Gold or stainless steel cusp 1
F.3360Preformed cusp 1
F.3400Karaya and sodium borate with or without acacia denture adhesive 1
F.3410Ethylene  oxide  homopolymer  and/or  carboxymethyl-cellulose  sodium
denture adhesive1
F.3450Ethylene oxide homopolymer and/or karaya denture adhesive 1F.3490Carboxymethylcellulose  sodium  and/or  polyvinylmethylether maleic acid
calcium-sodium double salt denture adhesive1
F.3520OTC dental appliance cleanser 1
F.3540OTC denture cushion or pad 1
F.3580Preformed gold denture tooth 1
F.3670Resin impression tray material 1
F.3740Retentive and splinting pin 1
F.3810Root canal post 1
F.3830Endodontic paper point 1
F.3840Endodontic silver point 1
F.3850Gutta percha 1
F.3900Posterior artificial tooth with a metal insert 1
F.3910Backing and facing for an artificial tooth 1
F.3980Endosseous dental implant accessories 1
F.4130Intraoral dental drill 1
F.4200Dental handpiece and accessories 1
F.4535Dental diamond instrument 1
F.4565Dental hand instrument 1
F.4620Fiber optic dental light 1
F.4630Dental operating light 1
F.4730Dental injecting needle 1
F.5410Orthodontic appliance and accessories 1
F.5525Preformed tooth positioner 1
F.6010Abrasive device and accessories 1
F.6030Oral cavity abrasive polishing agent 1
F.6050Saliva absorber 1
F.6100Anesthetic warmer 1
F.6140Articulation paper 1
F.6200Base plate shellac 1
F.6250Dental chair and accessories 1
F.6290Prophylaxis cup 1
F.6300Rubber dam and accessories 1
F.6475Heat source for bleaching teeth 1
F.6570Impression tube 1
F.6640Dental operative unit and accessories 1
F.6710Boiling water sterilizer 1
F.6870Disposable fluoride tray 1
F.6880Preformed impression tray 1
F.6890Intraoral dental wax 1GEAR,NOSE,AND THORAT DEVICES
Classification
NumberClassification Name Class
G.1100Earphone cushion for audiometric testing 1
G.1600Olfactory test device 1
G.1925Toynbee diagnostic tube 1
G.3300Hearing aid 1
G.3540Prosthesis modification instrument for ossicular replacement surgery 1
G.3900Nasal dilator 1
G.4100Epistaxis balloon 1
G.4140Ear, nose, and throat bur 1
G.4175Nasopharyngeal catheter 1
G.4350Ear, nose, and throat fiberoptic light source and carrier 1
G.4420Ear, nose, and throat manual surgical instrument 1
G.4750Laryngostroboscope 1
G.4770Otoscope 1
G.4780Intranasal splint 1
G.4800Bone Particle collector 1
G.5220Ear, nose, and throat drug administration device 1
G.5300Ear, nose, and throat examination and treatment unit 1
G.5550Powered nasal irrigator 1
G.5800External nasal splint 1
G.5840Antistammering device 1
HGASTROENTROLOGY-UROLOGY DEVICES
Classification
NumberClassification Name Class
H.1075Gastroenterology-urology biopsy instrument 1
H.4530Gastroenterolgy-urology fiberoptic retractor 1
H.4560Ribdam 1
H.4590Interlocking urethral sound 1
H.4730Manual gastroenterolgoy-urology surgical instrument and accessories 1
H.4890Urological table and accessories 1
H.5030Continent ileostomy catheter 1
H.5090Suprapubic urological catheter and accessories 1
H.5130Urological catheter and accessories 1
H.5160Urological clamp for males 1H.5210Enema kit 1
H.5450Rectal dilator 1
H.5520Urethral dilator 1
H.5900Ostomy pouch and accessories 1
H.5970Hernia support 1
H.5980Gastrointestinal tube and accessories 1
IGENERAL AND PLASTIC SURGERY DEVICES
Classification
NumberClassification Name Class
I.1800Speculum and accessories 1
I.3250External facial fracture fixation appliance 1
I.3800External aesthetic restoration prosthesis 1
I.3900Inflatable extremity splint 1
I.3910Noninflatable extremity splint 1
I.3925Plastic surgery kit and accessories 1
I.4014Nonresorbable gauze/sponge for external use 1
I.4018Hydrophilic wound dressing 1
I.4020Occlusive wound/burn dressing 1
I.4022Hydrogel wound dressing and burn dressing 1
I.4025Silicone scar management product 1
I.4040Medical apparel 1
I.4100Organ bag 1
I.4160Surgical camera and accessories 1
I.4200Introduction/drainage catheter and accessories 1
I.4320Removable skin clip 1
I.4370Surgical drape and drape accessories 1
I.4380Drape adhesive 1
I.4440Eye pad 1
I.4450Nonabsorbable gauze for internal use 1
I.4470Surgeon's gloving cream 1
I.4660Skin marker 1
I.4680Nonpowered, single patient, portable suction apparatus 1
I.4700Surgical microscope and accessories 1
I.4730Surgical skin degreaser or adhesive tape solvent 1
I.4760Removable skin staple 1
I.4800Manual surgical instrument for general use 1
I.4820Surgical instrument motors and accessories/attachments 1I.4930Suture retention device 1
I.4950Manual operating table and accessories and manual operating chair and
accessories1
I.4960Operating tables and accessories and operating chairs and accessories 1
I.5350Needle-type epilator 1
I.5360Tweezer-type epilator 1
I.5900Nonpneumatic tourniquet 1
I.5910Pneumatic tourniquet 1
JGENERAL HOSPITAL AND PERSONAL USE DEVICES
Classification
NumberClassification Name Class
J.0003Medical Pressure Garment 1
J.2200Liquid crystal forehead temperature strip 1
J.2900Clinical color change thermometer 1
J.5075Elastic bandage 1
J.5090Liquid bandage 1
J.5110Hydraulic adjustable hospital bed 1
J.5120Manual adjustable hospital bed 1
J.5150Nonpowered flotation therapy mattress 1
J.5160Therapeutic medical binder 1
J.5180Burn sheet 1
J.5210Intravascular catheter securement device 1
J.5240Medical adhesive tape and adhesive bandage 1
J.5270Neonatal eye pad 1
J.5300Medical absorbent fiber 1
J.5420Pressure infusor for an I.V . bag 1
J.5510Non-AC-powered patient lift 1
J.5550Alternating pressure air flotation mattress 1
J.5560Temperature regulated water mattress 1
J.5680Pediatric position holder 1
J.5740Suction snakebite kit 1
J.5780Medical support stocking 1
J.5820Therapeutic scrotal support 1
J.5950Umbilical occlusion device 1
J.6025Absorbent tipped applicator 1
J.6150Ultrasonic cleaner for medical instruments 1
J.6230Tongue depressor 1
J.6280Medical insole 1J.6375Patient lubricant 1
J.6430Liquid medication dispenser 1
J.6450Skin pressure protectors 1
J.6775Powered patient transfer device 1
J.6785Manual patient transfer device 1
J.6820Medical disposable scissors 1
J.6890General purpose disinfectants 1
J.6900Hand-carried stretcher 1
J.6910Wheeled stretcher 1
J.6960Irrigating syringe 1
J.6970Liquid crystal vein locator 1
J.6980Vein stabilizer 1
KNEUROLOGICAL DEVICES
Classification
NumberClassification Name Class
K.1200Two-point discriminator 1
K.1500Esthesiometer 1
K.1525Tuning fork 1
K.4030Skull plate anvil 1
K.4060Ventricular cannula 1
K.4125Neurosurgical chair 1
K.4190Clip forming/cutting instrument 1
K.4200Clip removal instrument 1
K.4325Cranial drill handpiece(brace) 1
K.4500Cranioplasty material forming instrument 1
K.4525Microsurgical instrument 1
K.4535Nonpowered neurosurgical instrument 1
K.4545Shunt system implantation instrument 1
K.4600Leukotome 1
K.4650Neurosurgical suture needle 1
K.4750Skull punch 1
K.4900Skullplate screwdriver 1
LOBSTETRICAL AND GYNECOLOGICAL DEVICES
Classification
NumberClassification Name ClassL.1640Culdoscope and accessories 1
L.1690Hysteroscope and accessories 1
L.1700Hysteroscopic insufflator 1
L.1720Gynecologic laparoscope and accessories 1
L.1730Laparoscopic insufflator 1
L.2900Fetal stethoscope 1
L.4520Obstetric-gynecologic general manual instrument 1
L.4530Obstetric-gynecologic specialized manual instrument 1
L.5900Therapeutic vaginal douche apparatus 1
L.5920Vaginal insufflator 1
L.6190Assisted reproductive microscopes and microscope accessories 1
MOPHTHALMIC DEVICES
Classification
NumberClassification Name Class
M.1040Ocular esthesiometer 1
M.1070Anomaloscope 1
M.1090Haidlinger brush 1
M.1140Ophthalmic chair 1
M.1160Color vision plate illuminator 1
M.1200Optokinetic drum 1
M.1250Euthyscope 1
M.1290Ophthalmic Fixation device 1
M.1320Fornixscope 1
M.1350Keratoscope 1
M.1375Bagolini lens 1
M.1380Diagnostic condensing lens 1
M.1390Flexible diagnostic Fresnel lens 1
M.1395Diagnostic Hruby fundus lens 1
M.1400Maddox lens 1
M.1405Ophthalmic trial lens set 1
M.1410Ophthalmic trial lens clip 1
M.1435Maxwell spot 1
M.1460Stereopsis measuring instrument 1
M.1605Perimeter 1
M.1650Ophthalmic bar prism 1
M.1655Ophthalmic Fresnel prism 1
M.1660Gonioscopic prism 1M.1665Ophthalmic rotary prism 1
M.1680Ophthalmic projector 1
M.1690Pupillograph 1
M.1700Pupillometer 1
M.1750Skiascopic rack 1
M.1790Nearpoint ruler 1
M.1800Schirmer strip 1
M.1810Tangent screen (campimeter) 1
M.1870Stereoscope 1
M.1905Nystagmus tape 1
M.1910Spectacle dissociation test system 1
M.1945Transilluminator 1
M.3200Artificial eye 1
M.4070Powered corneal burr 1
M.4250Ophthalmic electrolysis unit 1
M.4300Intraocular lens guide 1
M.4335Operating headlamp 1
M.4350Manual ophthalmic surgical instrument 1
M.4360Ocular surgery irrigation device 1
M.4370Keratome 1
M.4570Ophthalmic surgical marker 1
M.4750Ophthalmic eye shield 1
M.4770Ophthalmic operating spectacles (loupes) 1
M.5600Ptosis crutch 1
M.5844Corrective spectacle lens 1
NORTHOPEDIC DEVICES
Classification
NumberClassification Name Class
N.1100Arthroscope 1
N.3000Bone cap 1
N.4200Cement dispenser 1
N.4210Cement mixer for clinical use 1
N.4220Cement monomer vapor evacuator 1
N.4230Cement ventilation tube 1
N.4540Orthopedic manual surgical instrument 1
N.5850Nonpowered orthopedic traction apparatus and accessories 1
N.5890Noninvasive traction component 1
N.5940Cast component 1N.5960Cast removal instrument 1
N.5980Manual cast application and removal instrument 1
OPHYSICAL MEDICINE DEVICES
Classification
NumberClassification Name Class
O.0003Topical refrigerant 1
O.0006Continuous Passive Motion Device 1
O.1175Electrode cable 1
O.3025Prosthetic and orthotic accessory 1
O.3075Cane 1
O.3100Mechanical chair 1
O.3150Crutch 1
O.3175Flotation cushion 1
O.3410External limb orthotic component 1
O.3420External limb prosthetic component 1
O.3475Limb orthosis 1
O.3490Truncal orthosis 1
O.3500External assembled lower limb prosthesis 1
O.3520Plinth 1
O.3640Arm sling 1
O.3665Congenital hip dislocation abduction splint 1
O.3675Denis Brown splint 1
O.3750Mechanical table 1
O.3760Powered table 1
O.3825Mechanical walker 1
O.3850Mechanical wheelchair 1
O.3930Wheelchair elevator 1
O.5125Nonpowered sitz bath 1
O.5150Powered patient transport 1
O.5160Air-fluidized bed 1
O.5170Powered flotation therapy bed 1
O.5180Manual patient rotation bed 1
O.5225Powered patient rotation bed 1
O.5700Cold pack 1
O.5710Hot or cold disposable pack 1
O.5720Water circulating hot or cold pack 1
O.5730Moist heat pack 1
O.5765Pressure-applying device 1O.5925Traction accessory 1
PRADIOLOGY DEVICES
Classification
NumberClassification Name Class
P.1350Nuclear scanning bed 1
P.1400Nuclear sealed calibration source 1
P.1410Nuclear electrocardiograph synchronizer 1
P.1640Radiographic film marking system 1
P.1760Diagnostic x-ray tube housing assembly 1
P.1830Radiologic patient cradle 1
P.1840Radiographic film 1
P.1910Radiographic grid 1
P.1920Radiographic head holder 1
P.1960Radiographic intensifying screen 1
P.1970Radiographic ECG/respirator synchronizer 1
P.2010Medical image storage device 1
P.2020Medical image communication device 1
P.5740Radionuclide teletherapy source 1
P.5780Light beam patient position indicator 1
P.6500Personnel protective shield 1