Medical Device Quality Management System Regulations  Draft  
Chapter 1 General Provisions  
Article 1  
This set of regulations is formulated in accordance with regulations of Paragraph 4, 
Article 22 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 medical devices are prescribed in accordance with 
the contents of medical device quality management system of the International 
Standard Organization (ISO 13485: Medical Devices — Quality Management 
Systems — Requirements for Regulator y Purposes).  
Article 3  
The terms used in this Part 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 use, 
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, durability, reliability, safety 
or performance of a med ical 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 interventi on, 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 actua l 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 mana gement: 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 establish a quality management system in writing in 
accordance with the provisions of these Regulations and maintain its eff ectiveness.  
The manufacturer shall take the following steps to establish, implement and 
maintain the requirements, procedures, activities or arrangements set out in the 
foregoing 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 order and interaction of the implementation process of the 
system mentioned in the first paragraph.  
Article 5  
The manufacturer shall take t he following measures on the quality management 
system process;  
1. The decision on the benchmarks 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 manufacturer shall establish a quality management system process in 
accordance with the provisions of thes e Regulations and supervise to ensure the 
implementation of the process.  
The formulation and changes of the foregoing process shall not be carried out 
without the impact assessment of the quality management system and the medical 
device to ensure complianc e 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 tr ustees 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 the 
effectiveness of planning, operation and control of the quality management system 
process;  
5. Other documents req uired by central competent authorities.  
Article 10  
The manufacturer shall establish a quality manual, and the content of which shall 
include the following items:  
1. The scope of the quality management system and reasons of exclusions from 
application or non-enforcement, if any;  
2. The procedures established by the quality management system;  
3. The interaction between quality management system processes.  
The foregoing quality manual shall document the file structure used by the quality 
management system.  
Article 11  
The manufacturer shall file for each type or series of medical devices as evidence 
that their manufacture complies with the provisions of the Act or these Regulations.  
The foregoing 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 documents used for the quality management system including the records shall 
be under control.  
The manufacturer shall establish control procedures in writing for the following 
matters:  
1. The review and approval of the foregoing documents before release and 
circulation; the same applies to the renewal and re -approval;  
2. The identification and verification of the serial number of v ersions 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 effectiveness of the planning and operation of the quality 
management s ystem, 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 manufactur er 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.  
Except as otherwise provided in these Regulat ions, 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. The records and docum ents thus developed shall be 
handled in accordance with the provisions of Article 13. 
Article 13  
The manufacturer shall establish and maintain a record sufficient enough to prove 
compliance with the requirements of the quality management system and effective 
operation. For the foregoing record, the provisions in the preceding Article apply 
mutatis mutandis.  
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.  
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.  
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 demands of customers and the laws and 
regulations that shall be complied with to satisf y the demands, and shall ensure 
their implementation.  
Article 16  
The top management shall ensure that the formulation of the quality policies 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 reviewe d 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.  
The foregoing qualit y 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 does not damage 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.  
Written statement shall be made on the relationship among the foregoing staffs 
whose jobs involve the management, execution, and monitoring of quality. The top 
management shall bestow on the staff the necessary power and the independence to 
exercise the power.  
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. Submissio n to the top management the report on the confirmation of the 
effectiveness of the quality management system and the necessary improvement 
measures;  
3. Promotion 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 shal l 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 ma nagement 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 o f 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 manageme nt system;  
11. Recommendations for improvement;  
12. Measures to cope with the amendments to the law.  
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 req uirements for implementing the first three sub -paragraphs above.  
Chapter 4 Resource Management  
Article 25  
The manufacturer shall confirm and provide the necessary resources to maintain the 
effective implementation of the quality management system and compl y 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 team members' 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 th e 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 personnel mentioned in the first sub-paragraphs 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 re cording, 
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 confus ion 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 informa tion systems.  
If the implementation of the maintenance or the lack of which on the 
aforementioned facilities affects the product quality, the manufacturer shall 
determine the content and frequency of the implementation of the maintenance 
activities; the im plementation 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 
contami nated 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 plan and establish the processes required for product 
realization, and the plans shall comply with other process requirements of the 
quality management system.  
The manufacturer shall specify in w riting the risk management process necessary 
for product realization. The implementation of risk management shall be recorded 
and kept on file.  
The content of planning mentioned in the first paragraph 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, mon itoring, 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 mee t the requirements.  
The content of the aforementioned planning shall be done in writing and specified 
in the format acceptable with the operation mode of the manufacturer.  
Article 32  
The manufacturer shall confirm the following matters:  
1. Requirement spec ified by the customers, which scope covers both before and 
after delivery;  
2. Requirement not specified by the customers, but is evidently necessary in order 
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 do cuments and inform its staffs 
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 to be implemented at 
each phase of the procedure;  
2. The verification, validation and design transfer measu res as implemented in each 
phase stated in the preceding sub -paragraphs;  
3. The duties and functions of the staffs at each phase of the procedure stated in the 
first sub -paragraphs;  
4. The method of tracing the design, development and output to its origina l items of 
input;  
5. 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 manufactu rer 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 product s; 
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 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 n ecessary 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, the 
manufacturer shall specify in writing its consistency verification plan and 
implement it accordingly.  
The content of the foregoing plan shall include the ve rification 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 consistenc y 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.  
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 mentione d 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 
in detai l. 
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 inten ded 
use of the medical devices.  
The control mentioned in the preceding paragraph regarding the content of the 
change shall be exercised in the following forms and be completed before the 
change takes place:  
1. Review;  
2. Verification;  
3. Necessary validation;  
4. Approval.  
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 maintained.  
Article 43  
The manufacturer should, for the design and development of each model or series 
of medical devices, establish and maintain a file.  
The foreg oing 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 en sure 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 pla n 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. Requirements on the acceptance, procedures, processes and equipment of the 
products;  
3. Requirement for qua lification of supplier personnel;  
4. Requirements of 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 t hat 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 the se 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 determi ne the 
impact 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 inform ation 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 maintained.  
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 pr ocedures 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 main tain 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 an d 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 n eed 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 fo r 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 reco rd 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 deter mine 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 c ontent of the foregoing record shall be traceable to the production batch of the 
medical device.  
Article 52  
The deficiencies of production or service, which cannot be revealed without being 
used or received, shall be confirmed by the operator of the proces s of production or service.  
Where the results of production or service cannot be verified by subsequent 
monitoring and measurement and as a result the deficiencies are not revealed 
without being used or received, the operator shall confirm its process of p roduction 
and service.  
The procedure of confirmation mentioned in the preceding paragraph to prove that 
the production and service are 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 confirmation procedures;  
The manufacturer shall establish procedures in writing to confirm the comp uter 
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 complia nce. 
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 precedi ng paragraph, their conclusions 
and 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.  
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 a re released, used, or installed.  The manufacturer shall establish in writing a single identification system for 
medical devices in accordance with relevant regulations.  
The identification procedure mentioned in the first paragraph shall be established in 
writing by the manufacturer and care shall be taken to ensure that the recycled 
product is separated from other products.  
Article 55  
The manufacturer should, within the scope and record content stipulated by laws 
and regulations, set in writing the traceability procedures of the sources and flows 
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 conditio ns 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 th e 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 v ehicles, 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 custome r 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 procedure s 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. Design ing and manufacturing 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 co nditions shall be under control and listed in records.  
The above two provisions also apply to the protection of product components.  Article 59  
The 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 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. Making necessary adjustments and readjustments and keeping a record of them;  
3. The calibration status shall be determined and identified;  
4. Avoiding adjustments that cause invalidated measurement res ults; 
5. 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 kee p 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 revalidation 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 
follo w-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 6 0 
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 appr opriate methods including statistical techniques and the scope of application.  
Article 6 1 
In order to evaluate the effectiveness of the quality management system, the 
manufacturer shall gather and monitor information on compliance with customer 
requirement s. 
The manufacturer shall formulate in writing the methods for collecting and using 
the information mentioned in the preceding paragraph.  
Article 6 2 
The manufacturer shall formulate in writing procedures for receiving and 
processing the information as ment ioned 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 th e 
manufacturer as a reference for risk management, monitoring and product 
conformity maintenance, and the process of product realization and improvement.  
Article 6 3 
The manufacturer shall formulate in writing the procedures and deadlines for 
complaints han dling, 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 sha ll 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 6 4 
The manufacturer shall handle the reporting of adverse incidents, recovery and 
advisory notices in accordance with the provisions of Article 4 8, Artic le 49  and 
Article 58 of th e Act and its stipulations, and formulate the procedures for 
operation.  
The notification, recovery and announcement as mentioned in the preceding paragraph shall be recorded and kept on file.  
Article 6 5 
The manufacturer shall perf orm 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 incl ude the division of powers and requirements 
related to the planning, execution, recording and reporting of audit results.  
Article 6 6 
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 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 6 7 
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 
implement ation of corrective measures.  
Article 6 8 
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 approp riate 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 recor ded, 
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 t he inspectors or testers of implantable medical devices, if the 
devices are used.  
Article 7 0 
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 7 1 
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 adopt ing 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 laws and regulations, and receive the approval of the responsible 
personnel. The name and title of the p erson giving the approval shall be recorded 
and kept on file.  
Article 7 2 
If any non -conformity is found after the product is released, the manufacturer shall 
take appropriate measures with regard to its impact or potential impact, and keep a 
record of the same.  
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 maintain ed by the 
manufacturer.  
Article 7 3 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 provisions of Chapter 5 . 
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 7 4 
The manufacturer shall formulate in writing the items and analysis proce dures 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 selectio n 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 expression s 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 analysi s 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 7 5 
The manu facturer 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 ment ioned 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 
followin g 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. Validation 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 effe ctiveness.  
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 actio ns 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 plan ning, formulation and implementation of preventive actions, and the 
necessary updating of quality system documents.  
4. Validation that the preventive actions are not in conflict with laws and 
regulations, and do not degrade the safety and performance of me dical 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 the 
implementation of preventive actions.  Chapter 7 Essential Mode  
Article 78  
The items of medical devices produced by the manufacturer are limited to those 
announced by the central competent authority in  accordance with regulations  of 
Paragraph 4, Article 22  of the Act. Each type or series of product shall be recorded 
and filed separately to implement measures of record control, complaint handling, 
and corrective and preventive actions.  
The manufacturer mentioned in the preceding paragraph, shall not be subject to 
other provisions of this Part of these Regulations, except for the provisions of 
Article 11, Article 13, Article 63, Article 76 and Article 77. 
Article 79  
The Regulations shall be implemented from the date of enforcement of the Act .