NMPA has issued a new notice that CA certificate holders (Agent) need to extend the validity period of their CA certificate for one year without any payment, based on the premise that the certificate information and function are not changed.

On May 10, 2019, NMPA began to issue digital certification (Certificate Authority, CA) used by electronic registration information system (eRPS). When overseas registrants apply for medical device registration online, agents need to provide their own CA certificate.

Qualtech Suggestion: NMPA's current registration application routes are divided into on-counter submission and online submission. In the future, online submissions will be gradually implemented. It is recommended that all manufacturers confirm whether their agent has applied for a CA certificate, to avoid delaying the registration application process.


CH: NMPA Releases New Guidance Document for Evaluation of Raw Material Changes in Non-Active Medical Devices

- CH: NMPA Publishes Draft of New Guidance Document of Human Factors in Medical Devices


Official press