Recently, the State Food and Drug Administration issued the “Announcement on the Comprehensive Implementation of Electronic Registration Certificates for Medical Devices” (hereinafter referred to as the “Announcement”), stating that based on a review of the issuance and application of early pilot trials, it was decided after research to fully implement electronic registration certificates for medical devices starting from November 1, 2022.
The announcement pointed out that in order to implement the important decisions and arrangements of the Party Central Committee and the State Council on deepening the reform of “decentralization, regulation and services”, optimize the business environment, further stimulate the development vitality of market entities, and provide enterprises with more efficient and convenient government services, the State Food and Drug Administration in 2020 In October, a pilot program was launched to issue registration certificates for domestically produced Class III medical devices and imported Class II and III medical devices, and registration certificate change documents associated with electronic registration certificates were gradually issued on a pilot basis. Currently, 14,000 electronic registration certificates and 3,500 registration certificate change documents for medical devices have been issued.
On the basis of summarizing the issuance and application of early pilot projects, the State Food and Drug Administration decided after research to fully implement electronic registration certificates for medical devices starting from November 1, 2022. The relevant matters are now announced as follows:
1. The scope of issuance of electronic registration certificates for medical devices this time includes registration certificates and registration change documents for domestic Class III, imported Class II and III medical devices approved by the State Food and Drug Administration starting from November 1, 2022.
2. The electronic registration certificate of medical devices has the same legal effect as the paper registration certificate. The electronic registration certificate has functions such as instant delivery, SMS reminder, license authorization, scan code query, online verification, and network-wide sharing.
3. Enterprises must first register and obtain real-name authentication in the online service hall of the State Food and Drug Administration, and enter the “My Certificate” column of the online service hall to view and download the corresponding electronic registration certificate. You can also log in to the “China Food and Drug Administration APP” to view the electronic registration certificate.
4. The electronic registration certificate for medical devices does not include product technical requirements, instructions and other accessories. The above attachments are pushed in the form of electronic files together with the electronic registration certificate of medical devices to the “My Certificates” column of the legal person space of the online service hall of the State Food and Drug Administration. They will be delivered once the push is successful. Enterprises can log in and download by themselves.
5. Applicants should properly keep the State Food and Drug Administration’s online service hall account number, electronic registration certificate and related attached electronic documents, etc.
6. For questions related to the use of electronic registration certificates for medical devices, please check the relevant columns of “Electronic Certificates” in the online service hall of the State Food and Drug Administration.