China to implement random inspections of medical devices to ensure market safety

Moving to better ensure the safety of medical devices available in China, the National Medical Products Administration (NMPA) in April announced it will implement random inspection regimens on the manufacture, management, distribution, and delivery of such devices already on the market.

Under mandates from the NMPA that went into effect on March 13, the NMPA and all its branches throughout China will formulate annual medical device quality sampling inspection plans and make arrangements for inspections in the first quarter of each year. The national sampling inspection will target devices deemed high safety risks, heavily used by clinics and those judged to be of questionable quality, among others.

Medical device registrants will be required to designate a person or enterprise within China to cooperate with the random inspection of the imported medical device.