Notice on Application for CA Certificate of the eRPS System

  • 2019-05-07
According to Opinions on Deepening Reform of Evaluation and Approval System and Encouraging Innovation in Drugs and Medical Devices  (TZ No. 42  [2017]) issued by General Office of the CPC Central Committee and the General Office of the State Council, the eRPS system of NMPA will soon start its pilot operation.  According to Network Safety Law of PRC, Electronic Signatures Law of PRC and other provisions for e-government affairs, medical device manufacturers need to log in the eRPS system by using their CA certificates to safeguard the safety of users' accounts and sign and seal electronic documents electronically. The application for and use of CA certificates were notified as follows:

I. Medical device applicants/registrants can apply for the CA certificates through the eRPS system from May 10, 2019. CA certificate applicants/holders should be agents of domestic enterprises manufacturing Class III medical devices or enterprises manufacturing imported medical devices. Each enterprise can apply for only one CA certificate with the function of signature and seal.
II. The applicants can log in with their accounts and passwords and enter the interface of "Application for CA certificates" after entering the enterprise service platform for medical device registration (website: http: // Please refer to the attachment for the operational procedures and management of CA application.

III. Enterprises using CA certificates should set up systems to specify the actual keepers (CA managers), use rights, purpose, registration and other contents. These enterprises should also properly keep the digital certificates, private keys and protection passwords issued by the center and avoid revealing, transferring or lending them to others. If any CA certificate is misappropriated, misused, forged or falsified due to improper keeping of any user and adverse outcomes are incurred, the user shall bear the corresponding legal liabilities.

IV. Center for Medical Device Evaluation, NMPA has established a team to guarantee the operation and services of the electronic application system and provide effective help for enterprises during the use of the electronic application system and the authentication of CA certificates. The applicants/registrants can get remote help through hotlines and online QQ communication groups or be guided in the business hall of the center.

Attachment: 关于CA申领和管理有关事宜的说明.docx

National Medical Products Administration
Center for Medical Device Evaluation
May 7, 2019