Apr 8, 2022

China’s National Medical Products Administration (NMPA) has issued revisions to the Medical Device Classification Catalog, as well as new provisions for medical device manufacture and distribution. If you are a medical device manufacturer doing business in China, you will want to take note of these new requirements.

How will the Medical Device Classification Catalog change?

The NMPA has issued revisions to the Medical Device Classification Catalog through the following: Announcement No. 25 of 2022 (link in Chinese), which specifies changes for 10 device types, and Announcement No. 30 of 2022 (link in Chinese), which specifies changes for 27 device types. The announcements also outline conditions for implementing the changes.

According to Emergo by UL sources, from the date of each announcement, the following conditions apply:

  • Applications will be processed according to the adjusted classification.
  • For applications that have been accepted but have not yet completed registration approval (including initial and renewal registrations), they will continue to be reviewed and approved according to the original classification. If approved, a registration certificate shall be issued, and the adjusted classification shall be indicated in the remarks column of the certificate.
  • For registered devices with classification changed from Class III to Class II, the validity of their registration certificates will continue. If renewal is required, it must be submitted six months before expiring, in accordance with the revised classification.
  • For changes to a registration issued under the previous classification, an application can be filed. If approved, the adjusted classification will be indicated in the remarks column of the registration change document.

How will the new provisions for medical device manufacture and distribution affect manufacturers?

If you are a medical device manufacturer or distributor who does business in China, please be aware of the NMPA’s new provisions for medical device manufacture and distribution. The NMPA has published the Provisions for Medical Device Manufacture (NMPA Order No. 53) and the Provisions for Medical Device Distribution (NMPA Order No. 54), which will commence on May 1, 2022 and simultaneously repeal the Provisions for Medical Device Manufacture (NMPA Order No. 7) and the Provisions for Medical Device Distribution (NMPA Order No. 8). (The links to these orders are in Chinese.)

According to Emergo by UL sources, Order No. 53 allows for the on-site inspection for domestic manufacturing sites of Class II and III devices to be combined with the required inspection for the product registration, to avoid repeated inspections. Additionally, Class I device manufacturers will undergo on-site inspection within three months of production filing, though they will still undergo a simpler production filing process.

Also, both Order No. 53 and Order No. 54 cancel the requirement to submit a copy of certain materials, including the business license, when applying for a license or filing. In addition, these Orders require manufacturers and distributors to submit a self-inspection report of their QMS before March 31 yearly.

Further details are outlined in the Orders. The NMPA also issued the Interpretation of the Provisions for Medical Device Manufacture and the Interpretation of the Provisions for Medical Device Distribution to explain the changes and requirements set out in Order No. 53 and Order No. 54, respectively.

Learn more about medical device regulations and compliance in China from Emergo by UL:

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  • Kathryn Burke's picture
    Kathryn Burke

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