The Notice of Electronic Registration Certificate for Medical Devices has been fully implemented since November 1, 2022.
E-certificates for domestic Class III, imported Class II and III devices became available on a pilot basis, 14,000 e-certificates and 3,500 modification registration dossiers have been issued since October 2020.
The Notice regulates that:
- The electronic certificates for initial and modification registration will be applicable to devices approved after November 1, 2022.
- The electronic certificate has the same legal effect as the paper one. It has the benefits of instant delivery, SMS reminder, license authorization, code scanning query, online verification, and network-wide sharing.
- The electronic certificate does not include PTRs, IFU and other annexes.
- Manufacturers must first register through the NMPA online service portal and have their real names authenticated.
This is a great leap forward for overseas manufacturers as often they do not realize the importance of the retaining the original copy of paper certificate in the China regulatory environment. The loss or not having the possession of paper copy could create extra work during renewal phase. Now with CA certificate application, filing review, or eRPS-ToC catalog requirements for China NMPA submissions, more and more product cycle management from submission to post market are managed centrally and electronically by NMPA.
Love to hear your challenges and best practices!
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Grace Fu Palma
ChinaMed Device, LLC
MA, U.S.
gpalma@ChinaMedDevice.com978-390-4453
www.ChinaMedDevice.com------------------------------