China Medical Device Standards and Technical Review Guidelines Issued in 2021 - Overview

China medical device standards have 35 new national standards and 146 new industrial standards with a total increase of 21% as compared to 2020. On January 19, 2022, the NIFDC (National Institutes for Food and Drug Control) announced a list of 181 new medical device standards issued in 2021.

As of December 2021, 1,849 medical device standards have been recorded:

Highlights - China medical device standards

• 235 National standards
  • 91 GB Standards
  • 144 GB/T Standards
• 1,614 Industry standards
  • 298 YY Standards
  • 1,316 YY/T Standards

The code name of the mandatory national standard is “GB”, and the recommended national standard is “GB/T”. The code name of the mandatory industry standard is “YY”, and the code name of the recommended industry standard is “YY/T”.

On January 25, 2022, the CMDE (Center for Medical Device Evaluation) under the NMPA (National Medical Products Administration) announced a list of 64 technical review guidelines issued and implemented in 2021.

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