Online Certificates (Trial) will be Issued for Newly Registered Medical Devices in China

The NMPA (National Medical Products Administration) announced (No. 117 – 2020) a trial program to issue electronic certificates to successful registrants from October 19, 2020 to August 31, 2021.

In the announcement, the NMPA addressed additional information about the trial program:
– Electronic certificates will only be issued for new product registrations, renewals or information changes approved after October 19, 2020 and must belong to one of the following class levels:
• Class III for domestic medical devices
• Class II and III for overseas medical device
– Both electronic and paper versions of the certificate will be issued at the same time during the trial period
– The product technical requirements (PTR) of the product will not be included in the electronic certificate
– Registrants can sign in to their account on NMPA’s official website or mobile application to download the electronic certificate

Although the electronic certificate will have the same legal effect of the paper certificate during the trial period, because the product technical requirements (known as the “PTR”) will not be included in the electronic certificate – and the PTR is a fundamental registration document in China – the practical effect for non-Chinese manufacturers will be little changed. Manufacturers must still guard their paper documentation closely, particularly if appointing a Chinese distributor as their NMPA Legal Agent.

By Jacky Li. Contact Cisema if you would like to learn more.