China News Service, October 27. According to the website of the State Food and Drug Administration on the 26th, the State Food and Drug Administration recently issued an announcement on the full implementation of electronic registration certificates for medical devices (2022 No. 91).

　　The announcement stated that in order to implement the important decision-making and deployment of the Party Central Committee and the State Council on deepening the reform of "decentralization, regulation and service", 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 will In October 2020, the registration certificates for domestic third-class, imported second- and third-class medical devices were issued on a pilot basis, and the registration certificate change documents associated with the electronic registration certificate were gradually issued on a pilot basis. Now 14,000 electronic registration certificates for medical devices, There are 3,500 registration certificate change documents.

　　On the basis of summarizing the issuance and application of the previous pilot, the State Food and Drug Administration has decided to fully implement the electronic registration certificate for medical devices from November 1, 2022.

The relevant matters are hereby announced as follows:

　　1. The scope of the issuance of the electronic registration certificate for medical devices is from November 1, 2022, and the registration certificates and registration change documents of domestic Class III, imported Class II and III medical devices approved by the State Food and Drug Administration.

　　2. The electronic registration certificate for 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, code scanning query, online verification, and network-wide sharing.

　　3. Enterprises must first register in the online service hall of the State Food and Drug Administration and have real-name authentication, and enter the "My License" column of the online service hall to view and download the corresponding electronic registration certificate.

You can also log in to the "China Drug Administration APP" to view the use of 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 to the "My License" column of the legal person space of the online office of the State Food and Drug Administration in the form of electronic files and the electronic registration certificate of medical devices.

　　5. The applicant should properly keep the account number of the online office of the State Food and Drug Administration, the electronic registration certificate and related electronic documents attached.

　　6. For issues related to the use of electronic registration certificates for medical devices, please refer to the relevant column of "Electronic Certificates" in the online office of the State Food and Drug Administration.

(Zhongxin Finance)

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