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

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

China Medical Device Standards
Saturday, 26 February 2022 / Published in Medical Device, News, NMPA Registration in China

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.

Tagged under: GB Standards, Industry Standards, Mandatory Standards, National Standards, YY standards

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