Jul 7, 2022

China’s National Medical Products Administration (NMPA) published a number of guidance documents pertaining to medical devices and IVD regulations, including medical device naming guidelines, QMS inspection rules, and medical device industry standards.

Announcement No. 26 of 2022: Generic naming guidelines for medical devices

China’s NMPA released Announcement No. 26 of 2022, which adds clarity to generic naming guidelines for medical devices (link in Chinese) in categories including:

  • Surgical instruments
  • Physical therapy instruments
  • Patient-bearing instruments
  • Ophthalmic instruments
  • Infusion, nursing and protective devices
  • Clinical laboratory testing devices

The regulations are intended to standardize generic names of medical devices in order to strengthen management over the device’s whole product life cycle.

Revised draft QMS inspection guidelines for medical device registration

The NMPA issued a draft revision of guidelines for verification of the Quality Management System for medical device registration, which applies to the on-site QMS inspection for the registration of Class II and III devices, where required. The guide outlines basic requirements, key inspection content and principles for on-site inspection result decisions.

These draft QMS inspection guidelines are intended to strengthen the supervision of the registration work and further improve the verification processes of the medical device registration quality management system.

Several medical device industry standards and amendments approved by NMPA

Chinese medical device regulators have published several medical device standards and amendments to improve the quality and safety of medical devices manufactured in China.

First, the NMPA issued Announcement No. 39 of 2022 (link in Chinese) to announce the release of YY 0307-2022 Laser Equipment Doped Neodymium-YTadium Aluminum Garnet Laser Treatment Machine. In addition, the announcement includes 55 medical device industry standards (including four mandatory standards), as well as revisions to the Industry Standards, YY 9706.241-2020 (Medical Electrical Equipment – Part 2-41: Particular Requirements for the Basic Safety and Essential Performance of Surgical Luminaires and Luminaires for Diagnosis) and YY/T 0872-2013 (Test Methods for Ureteral Stents). Additional information on each is available in the annexes attached to the announcement.

Second, the NMPA issued Announcement No. 44 of 2022 (link in Chinese) in order to encourage research, development and innovation and improve the quality of new biomaterials of recombinant human collagen, such as those used in plastic surgery procedures.

Emergo by UL advisors will post further updates on China’s regulations as they are released.

Learn more about Chinese medical device and IVD regulations at Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Medical device clinical and testing requirements assessment for China
  • Whitepaper: China NMPA medical device registration
  • Webinar: Medical device registration in China

Author

  • Kathryn Burke's picture
    Kathryn Burke

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