China – NMPA rules on medical device naming, QMS inspections and industry standards

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…