At the end of February 2021, the National Medical Products Administration (NMPA) released the “Annual Report on the Management of China’s Medical Device Standards (2020)“. The report summarizes the progress of medical device standardization work in 2020, and more in general during the 13th Five-Year Plan period. The key points are as follows:
- In 2020, standardization plans were developed for 27 medical device national standards and 87 medical device industry standards. While 24 medical device national standards, 125 medical device industry standards, and 10 medical device industry standards amendments were published.
- By 31 December 2020, there were a total of 1,758 medical device standards. Among these, 286 standards (16% of total) relate to foundations; 54 (3%) relate to management; 422 (24%) to methods; and 996 (57%) to
- By 31 December 2020, there were 397 effective medical device mandatory standards, accounting for 23% of the total. Among these, 92 are national standards and 305 are industry standards. Furthermore, 106 of these mandatory standards (27% of the total) are basic general standards (27%), 2 (1%) are method standards, and 289 (72%) are product standards.
- In April 2020, the new version of GB 9706.1-2020 “Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Basic Performance” was officially released. The standard, which will be implemented on 1 May 2023, will be the basis that all medical electrical equipment must follow. This standard, and its related parallel and vertical standards, all adopt the IEC 60601 series, of which 74 IEC 60601 series standards are suitable for conversion. By 31 December 2020, 15 standards were issued, 39 were completed and revised (under review and publication), 15 were under revision, and 5 special safety standards for which conversion is needed were at the national standard project application stage.
- In 2020, China proposed 9 medical device international standardization projects, including “Medical Infusion Set Part 15: Light-proof Infusion Set“, and “Tissue Engineering Medical Products-Quantitative Detection Method for Residual DNA of Acellular Matrix Scaffold Materials“. 1 project was successfully initiated, and 2 projects were approved by member states, entering the project approval voting stage.
- Among the 8 international standards for medical devices whose formulation is led by China, the first international standard project relating to the prevention and control of the COVID-19 has ended the voting on the Draft International Standard (DIS). Four other international standard projects, including “Cardiovascular Implants-Heart Occluder” and “Medical Infusion Sets Part 15: Light-proof Infusion Sets“, have passed the Committee Draft stage voting, entering the Draft International Standard voting stage. “Tissue Engineering Medical Products Cartilage Nuclear Magnetic Evaluation Part 1: Adoption The clinical evaluation method of dGEMRIC and T2 Mapping technology” was adjusted from technical report to the technical specification, the project establishment voting stage was unanimously agreed by the member states, and the working group draft discussion stage was started.
- In 2020, 322 mandatory medical device standard texts and 808 non-adopted voluntary standard texts were published on the website of the Medical Device Standards Management Center of the National Medical Products Administration.