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China: Public Announcement on adjusting part content of the Classification Catalogue of Medical Devi

  • Writer: ARQon
    ARQon
  • May 6, 2022
  • 2 min read

In March of 2022, China’s National Medical Products Administration (NMPA) released an announcement that there will be an adjustment to the content and implementation requirements. In Announcement No. 25 of 2022, there are specific changes for 10 device types and in Announcement No. 30 of 2022, there are specific changes for 27 device types.

Some of the conditions that apply:

  • Applications will be processed based on the classification of the products

  • Registered devices with classifications that changed from Class 3 to 2, the validity of the registration certificate will continue. However, renewal must be submitted six months before expiring.

  • Application could be filed if there are changes to a registration issued under the previous classification. The adjusted classification will be shown in the remarks column if the application has been approved. If you produce or distribute medical devices in China, you should be aware of the NMPA's new medical device manufacturing and distribution rules. Order No. 53, on-site inspection of domestic manufacturing sites of Class II and III devices to be coupled with the required product registration inspection to avoid repeat inspections. Additionally, within three months of production filing, Class I device makers will be subjected to on-site inspection, albeit they will still be subjected to a shorter production filing process. In addition, Orders No. 53 and 54 remove the necessity to produce a copy of certain paperwork, such as the business license, while applying for a license or filing. Furthermore, these Orders mandate that manufacturers and distributors provide an annual self-inspection report on their QMS by March 31.

Sources:

Announcement of the State Food and Drug Administration on Adjusting some contents of the “Medical Device Classification Catalog” (2022 No.25)

https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20220324153614110.html

Announcement of the State Food and Drug Administration on Adjusting some contents of the “Medical Device Classification Catalog” (2022 No.30)

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