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, 1849 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.