The State Drug Administration issued a document stating that the national medical device standardization work puts forward new requirements!

On March 30, the National Drug Administration issued the "Opinions of the National Drug Administration and National Standardization Management Committee on Further Promoting the High-quality Development of Medical Device Standardization".

All provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps Market Supervision Bureaus (departments, committees), drug regulatory bureaus, national professional standardization technical committees and sub-technical committees in various medical device fields, various medical device standardization technology focal units, and related units:

Medical equipment ** is closely related to the health and lives of the people and is an important part of a healthy China. In recent years, medical device technology and industry have developed rapidly, medical device regulatory reform has been intensified, innovation, quality, and efficiency have continued to improve, and medical device standardization has played an important role in basic guarantees. In order to implement the spirit of the Fifth Plenary Session of the 19th Central Committee, implement the Party Central Committee and the State Council's decision and deployment of standardization work, adhere to the scientific, legal, international, and modern development direction, and lay a solid foundation for medical device supervision and high-quality industrial development with high standards. To give better play to the supporting and leading role of standards in the leap from a major country in manufacturing equipment to a powerful country in manufacturing equipment, the following opinions are hereby for further strengthening the standardization of medical devices:

1. General requirements

(1) Guiding ideology. Guided by Xi Jinping’s thoughts on socialism with Chinese characteristics in the new era, implement the development of strategic emerging industries and comprehensively promote the construction of a healthy China major strategic deployment, implement the reform of standardization and the reform of the medical device review and approval system, and improve the "** rigorous standards" "Working system, to better play the important supporting role of standards in safeguarding ** and promoting development.

(2) Main goals. By 2025, it will be basically completed to meet the needs of my country’s medical device development, production, operation, use, supervision and management of the entire life cycle, meet the new requirements of strict adherence to the bottom line of ** and boost quality, and be in line with international standards, with Chinese characteristics, and science. The advanced medical device standard system realizes the overall improvement of standard quality, the higher-quality, timely and diversified standard supply, the more complete, efficient and coordinated standard management, and the deeper and more effective standard international exchanges and cooperation.

2. Key tasks

(1) Optimize the standard system

1. Improve the standard system structure. Research and formulate general principles and basic requirements for the construction of the standard system, rationally plan the layout of the standard system, and scientifically formulate standard plans around the major deployment of medical device supervision and industrial development. Implement the statistical analysis and reporting system for the implementation of mandatory national standards, comprehensively carry out mandatory standard assessments, continue to optimize the mandatory standards for medical devices, strictly limit the scope of mandatory standard formulation, and gradually apply the wide-ranging and influential mandatory industries Standards are transformed into mandatory national standards. Optimize the recommended standards, and focus on supporting the formulation and revision of recommended national standards that are basic and universal, compatible with mandatory national standards, and have a leading role in the industry; encourage the formulation and revision of recommended industry standards in emerging technology fields and urgently needed by supervision. Cultivate the development of group standards and encourage social groups to actively develop group standards in the field of medical devices around new technologies and new business formats. Establish and form a medical device standard system with reasonable structure, clear levels, coordinated and supporting facilities, keeping the bottom line to ensure **, and chasing the high line to promote development.

2. Strengthen the development of basic general standards. Improve medical device terminology definitions, marking and identification, risk management, quality management, clinical evaluation management, usability engineering, statistical technology, digital ** and other basic standards covering the entire life cycle of medical devices. Speed up the formulation and revision of general standards such as basic safety and basic performance, biological evaluation of medical electrical equipment.

3. Strengthen the development of active medical device standards. Accelerate the advancement of common technology research and standard formulation of medical equipment in emerging fields such as medical robots, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology integration. Explore and promote the formulation of standards for key core components of medical devices. Improve medical respiratory and anesthesia equipment, disinfection and sterilization equipment, oral digital equipment, medical body circulation equipment, radiotherapy and nuclear medicine equipment, medical ultrasound equipment, physical therapy equipment, medical laboratory equipment, medical X-ray diagnostic equipment, and medical laser equipment , Medical radio frequency equipment and other high-end medical equipment related standards.

4. Strengthen the development of passive medical device standards. Strengthen the research of new biomedical material standards, and promote the formulation and revision of new technologies, new processes, and new materials standards for drug-device combination products, additive manufacturing, biodegradable products, tissue engineering products, recombinant collagen products, and nanometer products. Carry out research on hazardous substance characterization and toxicological evaluation methods and standard formulation. Establish a standard system for preclinical animal testing. Intensify the standardization of new products such as passive implants, medical dressings, biological protective equipment, dental equipment, and optics.

5. Strengthen the development of standards for in vitro diagnostic reagents. Accelerate the development of standards for diagnostic reagents and related methods for high-risk infectious diseases, and carry out research on in vitro diagnostic reagent standards for the prevention and control of new coronary pneumonia**. Promote the formulation and revision of standards in the fields of high-throughput sequencing and other new molecular diagnostic technologies, clinical mass spectrometry technologies, companion diagnostic reagents, point-of-care testing, traceability and reference measurement systems.

(2) Strengthen the refined management of standards

6. Promote the rapid formulation of urgently needed standards. Implement the spirit of deepening the reform of standardization, and ensure the urgently needed standards for the supervision of public health security for major emergencies, etc., and quickly establish projects, quickly formulate, and publish them in a timely manner. For important compulsory standards that are large in quantity, wide in scope, strong in influence, and urgently needed by supervision, as well as domestic and international new technologies and new industry-related standards, after expert argumentation, the conditions are mature, and enter the fast track of standard formulation and revision.

7. Optimize the working mechanism of standard formulation and revision. Comprehensively sort out the working procedures of each link of standard formulation and revision, optimize the working mechanism around quality and efficiency, encourage enterprises, scientific research institutes, social organizations and other related parties to actively participate in the standard formulation and revision work, and guide industry leaders to play a better role in the standard formulation and revision work. Great effect. Strengthen standard verification, extensively publicly solicit verification units, and expand the coverage of verified products. The scope of mandatory standard verification should cover typical products. Explore the establishment of medical device standard verification points.

8. Speed up the standard update speed. Re-examine relevant standards with rapid technological development in a timely manner to ensure the scientificity, applicability, and advancement of the standards. Establish a standard update mechanism that quickly links with international standards, explore the synchronization of domestic and international standards, and shorten the conversion cycle of international standards. Strengthen the tracking, comparison and evaluation of international standards, and timely transform international standards in line with my country's national conditions on the premise of complying with the copyright policies of relevant international organizations, and improve the consistency of domestic and foreign standards.

(3) Strengthen standard supervision and implementation

9. Implement the main responsibility of the enterprise in the implementation of the standard. Further consolidate the main responsibility of enterprises for implementing the standards, and use the standards as the basis and means for risk control in production and operation, and ensure that the products manufactured meet the mandatory standards and the technical requirements of the registered or filed products. Encourage enterprises to formulate product technical requirements that are higher than national standards and industry standards, support enterprises to target advanced benchmarking enterprises to implement technological transformation, and actively guide enterprises to improve product quality. Explore the establishment of a self-disclosure and supervision system for product implementation standards, and form a standard implementation supervision mechanism that parallels corporate commitments and social supervision. Promote a group of standard implementation "benchmark" enterprises.

10. Strengthen the implementation of standards. Medical device regulatory authorities at all levels should incorporate standard publicity and implementation training into the annual training plan, and regard the implementation of standards as an important part of daily supervision and inspection, and supervise and urge enterprises to implement the main responsibility of quality **. Strengthen the implementation mechanism of mandatory standards in the process of inspection, review, approval, licensing, inspection, law enforcement, etc., to ensure the strict implementation of mandatory standards. Actively encourage the implementation of recommended standards, promote normative documents or guidance documents to actively quote recommended standards, and unify implementation standards. Unblock the complaint and report channels for standard implementation, strengthen social supervision of standard implementation, and strive to create a good social governance situation in the field of standardization.

11. Improve the standard implementation feedback coordination mechanism. Improve medical device standard implementation information feedback and communication channels, and establish a medical device standard opinion feedback platform. Strengthen the standard interpretation work, improve the standard interpretation mechanism, and promptly solve the feedback problems in the standard implementation process. Establish a standard coordination and resolution mechanism, strengthen cross-industry and cross-field standard cooperation, and promote the unified implementation of standards. Improve the evaluation mechanism of standard implementation, organize the evaluation of standard implementation, and realize the closed-loop management of standards.

(4) Improve the medical device standard organization system

12. Strengthen the construction of the organizational system. Establish a leading group for deepening the reform of medical device standardization work to provide support for the top-level design of the medical device standard system and major strategic decisions. Optimize the system structure of the national professional standardization technical committee, sub-committees and the medical device standardization technical focal unit (hereinafter referred to as the "medical device standardization committee and focal unit") in the medical device field, and rationally arrange the standardization organization. Accelerate the establishment of medical equipment standardization organizations in urgently needed and strategic emerging industries such as the Technical Committee for Standardization of Medical Protective Products. Coordinating and solving the cross-over problem of management in the field of medical devices and other industries. Establish a cross-field and comprehensive medical device standard joint working mechanism to achieve complementary advantages and overall improvement.

13. Strengthen the management of the Medical Device Standards Committee and the central unit. Further strengthen and standardize the management of the Medical Device Standards Committee and the centralized unit, optimize the composition of committee members, enhance the broadness, representativeness, and advancement of the composition of committee members, and strengthen the management of core personnel such as the chairman, deputy directors, and secretary-general. Establish an evaluation index system for the medical device standard committee and the centralized unit, increase the intensity of the evaluation work, strengthen the application of the evaluation and evaluation results, improve the evaluation incentive and exit mechanism, and give a public report to the outstanding medical device standard committee and the centralized unit. Implementation of dynamic adjustments to failure to perform due diligence.

(5) Deepen international exchanges and cooperation

14. Deeply participate in international standardization activities. Deepen the exchanges and cooperation with the International Organization for Standardization, participate more extensively and more deeply in the collaborative verification of international standards, recommend more experts to become registered experts of the International Standard Organization, and actively participate in international standardization activities. Encourage active participation in the formulation and revision of international standards, put forward more international standard project proposals in the field of medical devices, and provide "Chinese wisdom" for international cooperation and exchanges in medical device supervision.

15. Deepen regional exchanges and cooperation. Actively play the role of medical device standards in the service and support of the "Belt and Road", guide and encourage domestic medical device companies, scientific research institutions, testing institutions, and review and inspection agencies to actively participate in the construction of the "Belt and Road", and encourage the formulation of national standards and industries The foreign language version of the standard promotes dialogue and exchanges on the work of medical device standards in countries along the route.

(6) Improve standard technical support capabilities

16. Improve standard technology support capabilities. Promote the in-depth integration of standardization work and the scientific and technological innovation system, focus on the effective connection of scientific research and standards, strengthen the support for standard scientific research, promote the close integration of medical device standardization with scientific and technological innovation, and industrial development, and incorporate medical device standards into the drug regulatory scientific action plan to maintain stability Support basic, strategic, cutting-edge key technical standards and research on common standards. Explore the organic connection of research on key issues in the field of medical device standards with the work of key laboratories in various fields.

17. Strengthen the construction of standard talent team. Give full play to the role of colleges and universities and the national drug regulatory bureau’s medical device supervision scientific research base, strengthen the construction of a medical device standard talent team, and ensure that there are full-time institutions and full-time personnel for standard management, and form a full-time standardization team as the main body and part-time standardization The team is a supplementary standard talent team. Relevant departments of medical device standardization combine their actual work to formulate standard talent training plans to cultivate a group of professional talents who understand professionalism, standard management, and have comprehensive coordination capabilities and an international perspective. Encourage medical device companies to establish standardized talent teams.

18. Strengthen the standard information management level. Further improve the standard informatization management level and increase the transparency of standard formulation and revision work. Further enhance the accessibility of standards, continue to promote the disclosure of mandatory standards, increase the disclosure of recommended standards, and comprehensively improve the ability and level of standard informatization services.

19. Establish an incentive mechanism for standard work. Encourage all relevant units to recognize standard results in scientific research awards, title review and work performance, explore the establishment of an incentive mechanism to participate in standard work, and praise relevant units and personnel who have made significant contributions to medical device standards.

3. Safeguard Measures

(1) Strengthen organization and leadership

Drug supervision and management departments at all levels and standardization administrative departments at all levels must attach great importance to medical device standardization, unify thinking, raise awareness, effectively strengthen overall coordination and organizational leadership, increase support for medical device standardization, closely integrate reality, and establish science Reasonable working mechanism, give full play to the joint efforts of all parties, to ensure the smooth development of medical device standardization.

(2) Strengthen funding guarantee

It is necessary to increase the funding support for medical device standards, set reasonable funding support standards based on the types of standards, and form a sustained and stable funding guarantee mechanism. Standard work funding should be earmarked for special purposes, and a long-term relationship related to standard formulation and revision and international standardization activities should be established. Effective investment mechanism to effectively guarantee standard formulation and revision, supervision of implementation, follow-up evaluation, and participation in the development of international standardization activities.

(3) Strengthen departmental collaboration

It is necessary to give full play to the role of the member unit of the Inter-Ministry Joint Conference for Standardization Coordination and Promotion of the State Council, do a good job in the organization and leadership of medical device standardization, strengthen communication and coordination with the Ministry of Industry and Information Technology, the National Health Commission and other departments, and firmly promote the standardization of medical devices. High-quality work development.

National Drug Administration National Standardization Management Committee

March 26, 2021

Editor: Xiao Huang