2021 Annual Report on China Medical Device Standards Management

Following the NIFDC (National Institutes for Food and Drug Control) announcement on the list of 181 new medical device standards in 2021, the NMPA (National Medical Products Administration) issued the 2021 annual report on China medical device standards management on February 18, 2022, to provide a comprehensive overview of the past year developments.

Highlights

• The 181 new medical device standards consist of 35 new national standards and 146 new industrial standards with a total increase of 21% as compared to 2020. Among the 35 new national standards,
  • 18 of them were supporting GB 9706.1 as safety standards for medical electrical equipment
  • 5 standards set out the quality evaluation requirements for coronavirus test reagents
  • 6 standards set out the quality and capacity requirements for clinical testing laboratories
  • 2 standards were for the biological evaluation of medical devices

• A total of 1,849 medical device standards have been recorded in China:
  • 235 National Standards:
    • 91 GB Standards
    • 144 GB/T Standards
  • 1,614 Industry Standards
    • 298 YY Standards
    • 1,316 YY/T Standards

• Among all medical device standards, the top 5 fields with the most standards distributed are:
  1. C44 medical laboratory equipment (14%)
  2. C35 orthopedic instruments (11%)
  3. C31 general and microsurgical instruments (11%)
  4. C33 dental devices, equipment and materials (10%)
  5. C43 medical radiation equipment (9%)

• Among the 181 new medical standards issued in 2021, the top 3 fields with the most standards distributed are:
  • C44 medical laboratory equipment
  • C30 comprehensive medical device
  • C43 medical radiation equipment

• The ISO 22679:2021 was officially released in November 2021 being the first international standard adopted from an industry standard (YY/T 1553-2017) from China. The standard specifies the important in vitro tests for cardiac occluders intended for transcatheter implantation in humans. China proposed 5 other global standards in 2021 whilst another 3 ISO standards have been reported to be at the DIS (Draft International Standard) stage.

By Julie Zhang and Jacky Li. Contact Cisema if you would like to learn more.