From October 19, 2020 to August 31, 2021, China will have a pilot run of electronic registration certificates issuance for medical devices. It will entail newly approved pre-market domestic Class III, foreign Class II and Class III medical devices. All other prior registered devices and registration renewals will be gradually issued the e-certificates.

The e-certificates for medical devices are issued simultaneously with the physical registration certificates. They will have the same legal effect. The e-certificates will not contain any Product technical requirements (PTR).

Manufacturers must first register with NMPA online. Then, upon entering the name of device as on certificate, they can view and download their e-certificate. Manufacturers can also log on to the “China NMPA” mobile app to view the e-certificates of their medical devices.



Announcement of NMPA on the Pilot Implementation of Electronic Registration Certificates for Medical Devices (No. 117, 2020)