China CMDE Adjust Management Method of the Electronic Declaration Information System (eRPS) for Medical Device Registration

Recently, China CMDE adjusts the digital certificate management method as follows:

Starting from April 15, 2024, the management of CA certificates and other matters will be transferred to the CA certificate issuing agency (Beijing Digital Certification Co., Ltd.). CA certificate applications, information changes, renewals, renewals and re-issuances, etc., shall be handled by the medical device registration applicant at the CA certificate issuing agency platform, and the relevant fees shall be borne by the medical device registration applicant.

Those who have submitted CA certificate applications in the CMDE Medical Device Registration Electronic Declaration Information System before April 15, 2024, and CA certificates that expire before April 15, 2024 and need to be renewed shall be processed according to the original process.