China – Notice on registration of medical device master files (No. 2 of 2021)

On March 5, 2021, the State Food and Drug Administration of China issued an announcement on the Registration of Medical Device Master Files. The relevant matters that facilitate the owner of the master file to handle registration include:

About the application for the digital certification (CA) certificate of the electronic application of medical device registration information system

The medical device master file registration platform and database belong to the medical device registration electronic Part of the application information system (eRPS), in accordance with the “Network Security Law of the People’s Republic of China” and “The Electronic Signature Law of the People’s Republic of China” and other relevant e-government regulations, in order to protect the security of user accounts and electronically signed electronic files. The owner of the master file must use the Certificate Authority (CA) certificate used in conjunction with the eRPS system to log in to the medical device electronic declaration information system before registering the master file.

Matters concerning the application and use of CA certificates are as follows:

(1) Starting from March 15, 2021, the domestic master file owner or the domestic agency commissioned by the import master file owner can apply for a CA certificate through the eRPS system. The CA certificate applicant/holder should be an enterprise legal person in China, and each enterprise can only apply for one CA certificate with signature function.

Companies that have already received the CA certificate do not need to apply repeatedly. After the medical device master file registration platform is opened, they can directly apply for the master file registration with a valid CA certificate.

(2) After the claimant enters the medical device registration enterprise service platform (http://erps.cmde.org.cn ) for user registration, the claimant can log in with the account password and enter “CA certificate application “Module.

(3) Units that use CA certificates should establish a system to clarify the actual custodian (CA certificate administrator), use authority, purpose, registration, etc. of the CA certificate. The CA user unit shall properly keep the digital certificate, private key and protection password issued by the Approval Center to avoid leakage, transfer, or lending to others. If the CA is stolen, fraudulently used, forged, or tampered with due to improper storage, and the resulting adverse consequences, the CA user unit shall bear the relevant legal responsibilities.

(4) The Approval Center provides assistance to the owner of the main document in the use of the electronic reporting system and the CA certificate certification process. The owner of the domestic master document or an agency in China entrusted by the owner of the imported master document can use the hotline, Online QQ exchange group to get remote help.

Regarding the registration

The owner of the domestic master document or an agency in China entrusted by the owner of the imported master document shall log in to the web page version of the medical device registration enterprise service platform with the CA certificate (http://erps) .cmde.org.cn ). Fill in the application form correctly according to the type of registration (registration or renewal registration). The eRPS system will automatically generate the corresponding catalog according to the type of registration. Please refer to Annex 2 for the main file registration electronic declaration catalog.

In order to facilitate the follow-up review center to review the main file materials after the relevant medical device registration application is submitted, the main file registration catalog and the eRPS system catalog use the same catalog code and title, which has been streamlined according to the actual situation, and only the reservation may be applicable. The domestic master file owner or an agency in China entrusted by the owner of the imported master file shall submit the master file registration materials item by item in accordance with the catalog.

After the registration information is successfully submitted, the medical device master file registration platform will feedback the medical device master file registration receipt, and the domestic master file owner or the domestic agency commissioned by the imported master file owner can view it with the CA certificate.