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…