National Medical Products Administration: China's medical device standards system continues to improve

Medical device standards are technical specifications jointly followed in the research, production, operation, use, and supervision and management of medical devices. They are important technical support for medical device supervision and industry development. The National Medical Products Administration attaches great importance to medical device standardization work. In accordance with the requirements of "the strictest four," and combining the actual situation of medical device industry development and regulatory work, it continuously improves the medical device standard management system and continuously carries out the formulation and revision of medical device standards. China's medical device standard system is constantly improving, and the technical support capabilities of medical device standards for supervision and industry development continue to increase.

I. Strengthening the Construction of Medical Device Standard Systems

In order to implement the major decision-making arrangements of the State Council to deepen standardization reform, based on the "Standardization Law of the People's Republic of China," and based on the actual situation of China's medical device industry development and supervision work, in April 2017, the former State Food and Drug Administration revised and issued the "Medical Device Standard Management Measures." The issuance of these measures has played a positive role in guiding the management of medical device standards in China, standardizing standard formulation and revision, promoting standard implementation, and improving the quality of medical devices. In order to implement the "Medical Device Standard Management Measures," the former State Food and Drug Administration successively issued documents such as "Management Specifications for the Formulation and Revision of Medical Device Standards" and "Detailed Rules for the Approval and Publication of Medical Device Standards," further standardizing the procedures for medical device standardization work, strengthening the refined process management of standards, and laying a solid institutional foundation for improving the quality of medical device standards.

II. Accelerating the Formulation and Revision of Medical Device Standards

Continuously implementing the medical device standard improvement plan, during the "Twelfth Five-Year Plan" and "Thirteenth Five-Year Plan" periods, we organized the formulation and revision of about 100 medical device standards each year, giving priority to major basic standards, general standards, high-risk product standards, and standards related to strategic emerging industries. In 2018, 99 medical device industry standard formulation and revision projects were selected and determined, and 104 medical device industry standards were reviewed and released. By the end of 2018, China had a total of 1618 medical device standards, including 219 national standards and 1399 industry standards. The consistency rate of China's medical device standards with international standards has reached more than 90%, the coverage and systematic nature of the standard system have been continuously strengthened, and the overall level of medical device standards has been continuously improved. Increasing the publicity of standards, establishing an open information platform for medical device standards, and achieving 100% openness of the text of mandatory medical device industry standards and the catalog information of recommended medical device industry standards.

III. Improving the Medical Device Standard Committee System and Management

Actively promoting the establishment of strategic emerging medical device-related standard committees, based on the existing 24 medical device standardization (sub) technical committees, and combining the actual situation of medical device industry development, in 2018, we actively prepared for the establishment of the National Standardization Technical Committee for External Implants and Orthopedic Devices, the Active Implant Subcommittee, the National Standardization Technical Committee for Biological Evaluation of Medical Devices, the Subcommittee for Biological Evaluation of Nanomedicine Devices, and the medical electrical acoustic equipment, medical additive manufacturing technology, and artificial intelligence medical devices three medical device standardization technical units, further improving the construction of the medical device standard organization system.

IV. Enhancing the International Voice of Medical Device Standards

Deeply participating in and promoting the relevant activities of the International Medical Device Regulators Forum (IMDRF) standards working group. In 2018, at the 13th IMDRF Management Committee meeting, the new work item proposed by China, "Updating the IMDRF member's recognized international standard list," was unanimously approved, achieving a historic breakthrough for China from participating in to leading the formulation of international standard recognition rules for medical devices. For the first time, we took the lead in formulating international standards for high-performance medical devices. At the 2017 annual meeting of the International Organization for Standardization Technical Committee 150 (ISO/TC 150), the international standard proposal for "Cardiovascular Implants, Cardiac Occluders" was approved, which was the first medical device industry standard in China to be transformed into an ISO international standard. This has important pioneering significance for promoting the internationalization process of China's medical device standards, effectively enhancing China's international voice in the field of medical devices, and promoting the alignment of China's standards with international standards.