Opinions of Standardization Administration of the State Medical Products Administration on Further Promoting high-quality development of standardization of Medical devices(National Drug Administration Notes on Devices (2021) No. 21)

Opinions of Standardization Administration of the State Medical Products Administration on Further Promoting high-quality development of standardization of Medical devices(National Drug Administration Notes on Devices (2021) No. 21)

  • Categories:Industry
  • Time of issue:2022-01-10 18:16

(Summary description)Medical device safety is closely related to people's health and life safety, and is an important part of healthy China. In recent years, with the rapid development of medical device technology and ind

Opinions of Standardization Administration of the State Medical Products Administration on Further Promoting high-quality development of standardization of Medical devices(National Drug Administration Notes on Devices (2021) No. 21)

(Summary description)Medical device safety is closely related to people's health and life safety, and is an important part of healthy China. In recent years, with the rapid development of medical device technology and ind

  • Categories:Industry
  • Time of issue:2022-01-10 18:16
  • Views:

Market Supervision Bureau (department, committee), Food and Drug Administration of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps, National Professional Standardization Technical Committee and sub-technical Committee in the field of medical devices, Centralized medical device standardization technology unit, relevant units:

Medical device safety is closely related to people's health and life safety, and is an important part of healthy China. In recent years, with the rapid development of medical device technology and industry, the regulatory reform of medical device has been deeply promoted, innovation, quality and efficiency have been continuously improved, and the standardization of medical device has played an important role in ensuring the basic guarantee. To implement the spirit of the fifth plenary session of the nineteenth, implement standardized work of the CPC Central Committee and state council on reform decision deployment, insist on scientific development direction, under the rule of law, internationalization, modernization, high-standard consolidate high quality medical device regulatory and industry foundation, better play to the standard in making machinery power machinery power across the supporting and leading role to the system, The following suggestions are put forward for further strengthening the standardization of medical devices:

I. General requirements

(1) Guiding ideology. New era of socialism with Chinese characteristics in jinping thoughts as the instruction, implements and realizes the development of strategic emerging industries and promoting the health of China construction major strategic deployment, the implementation of the reform of standardization work and review of medical equipment examination and approval system reform, improve the work "the most rigorous standard" system, play a better standards in safety, an important support role in promoting development.

(2) Main objectives. By 2025, the basic construction to adapt to China's medical equipment development, production, management, use, supervision and management of the whole lifecycle management needs, accord with adherence to safety line and high speed wire rod new booster quality requirements, in line with international standards, with Chinese characteristics, scientific and advanced medical devices standards system, implementation standards improve quality, standard supply more high quality, timely, diverse, Standards management will be improved, efficient and coordinated, and international exchanges and cooperation on standards will be deepened and more effective.

Key tasks

(1) Improving the standard system

1. Improve the standard architecture. To study and formulate general principles and basic requirements for the construction of the standard system, reasonably plan the layout of the standard system, and scientifically prepare the standard plan centering on the major deployment of medical device regulation and industrial development. We will implement the statistical analysis and reporting system for the implementation of mandatory national standards, carry out comprehensive evaluation of mandatory standards, continue to optimize the mandatory standards for medical devices, strictly limit the scope of the formulation of mandatory standards, and gradually transform the widely applicable and influential mandatory industry standards into mandatory national standards. We will optimize recommended national standards, with the focus on supporting the formulation and revision of recommended national standards that are general in basis, compatible with mandatory national standards, and play a leading role in industry. Encourage emerging technology areas, and supervise the revision of recommended industry standards that are urgently needed. We will foster the development of group standards, and encourage social organizations to actively develop group standards in the field of medical devices centering on new technologies and new forms of business. Establish and form a medical device standard system with reasonable structure, clear hierarchy, coordination and matching, and keep the bottom line to ensure safety and promote development.

2. Strengthen the development of basic universal standards. Improve the basic standards covering the whole life cycle of medical devices, such as term definition, labeling, risk management, quality management, clinical evaluation management, availability engineering, statistical technology, digital safety, etc. We will accelerate the formulation and revision of general standards for basic safety and performance and biological evaluation of medical electrical equipment.

3. Strengthen the development of standards for active medical devices. We will accelerate research on generic technologies and standard-setting in emerging areas of medical devices, including medical robotics, artificial intelligence, active implants, medical software, 5G+ industrial Internet, and multi-technology convergence. Explore and promote the formulation of standards for key core components and components of medical devices. Perfect medical breathing and anesthesia equipment, disinfection equipment, oral digital equipment, medical body follow equipment, radiation therapy and nuclear medicine, medical ultrasound equipment, physiotherapy equipment, medical laboratory equipment, medical X-ray diagnostic equipment, medical laser equipment, medical radio-frequency devices in areas such as high-end medical equipment related standards.

4. Strengthen the development of standards for passive medical devices. We will strengthen research on standards for new biomedical materials, and promote the formulation and revision of standards for new technologies, processes and materials, such as pharmaceutical combination products, additive manufacturing, biodegradable products, tissue engineering, recombinant collagen and nano materials. To carry out research on characterization and toxicological evaluation methods of hazardous substances and establish standards. To establish a standard system for preclinical animal testing. The standardization of new products such as passive implants, medical dressings, biological protective devices, oral instruments and optics will be carried out.

5. Strengthen the development of in vitro diagnostic reagent standards. We will accelerate the formulation of standards for diagnostic reagents and related methods for high-risk infectious diseases, and carry out research on standards for in vitro diagnostic reagents for COVID-19 prevention and control. The standardization and revision of new molecular diagnostic technologies such as high-throughput sequencing, clinical mass spectrometry, companion diagnostic reagents, real-time testing, traceability and reference measurement systems will be promoted.

2. Strengthening standard and refined management

6. Expediting the formulation of urgently needed standards. We implemented the spirit of deepening standardization reform, and quickly approved, formulated and released urgently needed standards for oversight and management of major emergencies and other emergencies to ensure public health safety. Important mandatory standards that are large in quantity and wide in scope, have strong influence and are in urgent need of supervision, as well as standards related to new technologies and new industries that are domestically initiated and internationally advanced, shall enter the fast track of standard system and revision after expert argumentation and conditions are ripe.

7. Optimize the working mechanism for formulating and revising standards. The working procedures of all links of standard formulation and revision are comprehensively sorted out, the working mechanism is optimized around quality and efficiency, enterprises, research institutes, social organizations and other relevant parties are encouraged to actively participate in the work of standard formulation and revision, and leading enterprises in the industry are guided to play a greater role in the work of standard formulation and revision. Strengthen the standard verification, widely open collection of verification units, expand the coverage of verification products. The scope of mandatory standard verification shall cover typical products. Explore the establishment of verification points for medical device standards.

8. Speed up the updating of standards. Timely review of relevant standards with rapid technological development to ensure that the standards are scientific, applicable and advanced. We will establish a mechanism for updating standards in rapid linkage with international standards, explore the possibility of simultaneous project approval of domestic and international standards, and shorten the transformation period of international standards. Strengthen tracking, comparison and evaluation of international standards, timely transform international standards in line with China'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. Strengthening oversight and implementation of standards

9. Implement the main responsibility of enterprises in the implementation of standards. Further compacting the main responsibility of enterprises to implement standards, standards as the basis and means of risk control in the production, operation and other links, to ensure that the ex-factory products meet the mandatory standards and product technical requirements registered or filed. We will encourage enterprises to set technical requirements higher than national and industry standards, support them in carrying out technological upgrading aimed at advanced benchmarking enterprises, and actively guide them to improve product quality. We will explore ways to establish a self-disclosure and supervision system for product implementation standards, and form a standard implementation supervision mechanism that combines enterprise commitment and public supervision. Publicize a group of standard implementation "benchmarking" enterprises.

10. Strengthen the implementation of standards. Medical device supervision departments at all levels shall incorporate standard publicity and implementation training into annual training plans, and take the enterprise's implementation of standards as an important content of daily supervision and inspection, and urge enterprises to implement the main responsibility for quality and safety. We will strengthen the enforcement mechanism for mandatory standards in the process of inspection, review, approval, licensing, inspection and law enforcement, and ensure strict enforcement of mandatory standards. We will actively encourage the implementation of recommended standards, encourage normative documents or guiding documents to actively cite recommended standards, and unify the standards for implementation. Open up channels for complaints and reports about the implementation of standards, strengthen social supervision over the implementation of standards, and strive to create a good situation of social co-governance in the field of standardization.

11. Improve the feedback and coordination mechanism for the implementation of standards. Improve information feedback and communication channels for the implementation of medical device standards, and establish a feedback platform for medical device standards. We will strengthen the interpretation of standards, improve the interpretation mechanism of standards, and timely solve the feedback problems in the implementation of standards. We will establish a mechanism for coordinating and resolving standards, strengthen cross-industry and cross-sector standards cooperation, and promote unified implementation of standards. We will improve the evaluation mechanism for the implementation of standards, organize and carry out the evaluation of the implementation of standards, and realize closed-loop management of standards.

(4) Improve the medical device standard organization system

12. Strengthen organizational systems. The leading group for deepening the reform of medical device standardization has been established to provide support for top-level design and major strategic decisions of the medical device standard system. Optimize the system structure of national Professional Standardization Technical Committee, sub-technical committee and medical device standardization technical focal point unit (hereinafter referred to as "Medical Device Standardization Committee and focal point Unit") in the field of medical devices, and rationally arrange standardization organizations. We will accelerate the establishment of standardization organizations for medical protective Products, including the Technical Committee for Standardization of Medical Protective Products, which are in urgent need of supervision and in strategic emerging industries. Coordinate and solve the overlapping problem of management between medical device field and other industries. Establish cross-field, comprehensive medical device standard joint working mechanism, achieve complementary advantages, overall improvement.

13. Strengthen the management of medical device standards committee and focal point units. Further strengthen and standardize the management of medical device standards committee and focal units, optimize the composition of committee members, enhance the universality, representativeness and advanced nature of the composition of committee members, strengthen the management of the chairman, vice chairman, secretary-general and other core personnel. Establish the assessment and evaluation index system of medical device standards committee and central unit, intensify the assessment and evaluation work, strengthen the application of assessment and evaluation results, improve the assessment incentive and withdrawal mechanism, give notice and praise to the medical device standards Committee and central unit with excellent work, and implement dynamic adjustment for those who cannot fulfill their duties.

Deepening international exchanges and cooperation

14. Participate deeply in international standardization activities. To deepen exchanges and cooperation with international standardization organizations, participate more extensively and deeply in the cooperation and verification of international standards, recommend more experts to become registered experts in international standards organizations, and actively participate in international standardization activities. Encourage active participation in the revision of international standards, put forward more proposals for international standards in the field of medical devices, and provide "Chinese wisdom" for international cooperation and exchanges in medical device regulation.

15. Deepen regional exchanges and cooperation. Active play to medical devices standards of "area" service and support, guide and encourage domestic medical equipment enterprises, scientific research units, testing institutions, review verification institutions actively participate in the "area" construction, encourages to develop national standards, industry standard version, promote dialogue and exchanges along the national medical equipment standard.

(6) Improve the standard technology support capacity

We will enhance our capacity to support standard science and technology. Promote standardization and technology innovation system of depth fusion, pay attention to scientific and effective connection standard, strengthen the standard research support ability, promote the standardization of medical instrument and combined closely with the scientific and technological innovation, industrial development, medical equipment standards should be brought into the drug regulatory science plan of action, steady support basic, strategic, key technology and common standards of frontier. To explore the organic connection between the research on key issues in the field of medical device standards and the work of key laboratories in various fields.

17. We will strengthen the training of qualified personnel. Give full play to the role of colleges and universities and sFDA medical device supervision and scientific research base, strengthen the construction of medical device standard talent team, ensure that there are full-time institutions and full-time personnel for standard management, and form a standard talent team with full-time standardization team as the main body and part-time standardization team as the supplement. The relevant departments of medical device standardization make standard personnel training plans based on the actual work, so as to cultivate a group of professional personnel with comprehensive coordination ability and international vision who understand specialty and standard management. Encourage medical device enterprises to establish a standardized talent team.

18. Strengthen standard information management. Further enhance the standard information management level, improve the transparency of the standard system and revision work. We will further enhance the accessibility of standards, continue to promote the disclosure of mandatory standards and recommended standards, and comprehensively improve the capacity and level of standard informatization services.

19. Establish standard work incentives. Encourage relevant units to recognize standard achievements in scientific research awards, professional title evaluation and work performance, explore the establishment of incentive mechanism for participation in standard work, and praise relevant units and personnel who have made significant contributions to the medical device standard work.

Iii. Safeguard measures

1. Strengthening organizational leadership

Pharmaceutical supervisory and administrative departments at all levels and the departments of Standardization Administration at various levels shall attach great importance to the standardization of medical equipment, unified thought, raise awareness, strengthen overall coordination and organizational leadership, strong support from medical equipment standardization work, with practice closely, and establish scientific and reasonable working mechanism, give full play to the parties together, Ensure smooth development of standardization of medical devices.

2. Strengthening financial support

It is necessary to increase the financial support for medical device standards, set reasonable financial support standards according to the types of standards, form a sustainable and stable funding guarantee mechanism, ensure that the standard work funds are earmarked for special use, and establish a long-term investment mechanism linked to the standard system and revision and international standardization activities. Ensure standard system and revision, supervise implementation, follow up evaluation and participate in international standardization activities.

(3) Strengthening departmental coordination

It is necessary to give full play to the role of the member units of the Inter-Ministerial Joint Conference on Standardization Coordination and Promotion under The State Council, organize and lead medical device standardization, strengthen communication and coordination with the Ministry of Industry and Information Technology, the National Health Commission and other departments, and steadily promote the high-quality development of medical device standardization.

Standardization Administration of the State Medical Products Administration

March 26, 2021


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