The Food and Drug Administration announced the full implementation of electronic registration certificates for medical devices

In order to implement the important decisions and deployments of the Party Central Committee and the State Council on deepening the reform of "decentralization, management and service", optimize the business environment, further stimulate the vitality of the development of market entities, and provide enterprises with more efficient and convenient government services, the State Food and Drug Administration piloted the issuance of domestic Class III, imported Class II and Class III medical device registration certificates in October 2020, and gradually piloted the issuance of registration certificate change documents associated with electronic registration certificates, and has issued 14,000 electronic registration certificates for medical devices and 03,500 registration certificate change documents
。 On the basis of summarizing the issuance and application of the pilot in the early stage, the NMPA 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 issuance of electronic registration certificates for medical devices is the registration certificates and registration change documents
of domestic Class III, imported Class II and Class III medical devices approved by the State Food and Drug Administration 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 in the online office hall of the State Food and Drug Administration and authenticate their real names, and enter the "My Licenses" column of the online office 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 use of electronic registration certificates
.

 

4.
The electronic registration certificate for medical devices does not contain product technical requirements, instructions and other accessories
.
The above attachments are pushed synchronously to the "My Licenses" column of the legal person space of the online office hall of the State Food and Drug Administration in the form of electronic documents, and the push will be delivered immediately, and enterprises can log in and download them by
themselves.

 

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

 

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

 

This is hereby announced
.

 

NMPA

 

October 24, 2022