General Administration of Medical Device Registration on matters relating to the announcement
Pharmaceutical Network November 4 hearing in accordance with the State Council, decentralization, decentralization, optimization of service requirements, for the convenience of medical device operators to handle the record, improve work efficiency, the State Food and Drug Administration decided to simplify the record submitted by medical device operators Information, optimization procedures.Now the relevant issues are announced as follows:
If an enterprise that has obtained the "Medical Device Operation Permit" applies for the record of the second type of medical device operation, it should fill in the second type of medical device operation record (see the attachment) in the medical device manufacturing and operation permission (record) information system. The second type of medical equipment business record sheet, stamped with the official seal to the location of the municipal food drug The supervisory and administrative department shall handle the record-keeping. The food and drug supervision and administration department shall check the completeness of the information submitted by the enterprise on the spot, record it in conformity with the provisions and issue it to the second category medical instruments Business record voucher.
At the same time apply for the third type of medical equipment business license and the second type of medical equipment for the record enterprise From the original submission of two sets of paper materials, the network upload two electronic documents, optimize the application for the third category of medical equipment business license to submit a set of paper materials, the network upload an electronic document, for the second type of medical equipment business record only Fill in the second type of medical equipment operation record sheet in the medical equipment production and operation permission (record) information system.After the enterprise prints the second type of medical equipment operation record sheet, affix the official seal and the third type of operation permission application material to the place District municipal food and drug administration to apply.Food and drug supervision and administration departments for the third type of medical equipment operation permit on-site inspection, can be completed with the second type of medical equipment on-site inspection of the record.
Special announcement.
Attachment: The second type of medical equipment business record (also engaged in the third type of medical equipment business)
Company Name
Uniform social credit code
Mode of operation
Warehouse address
Business Scope
The company promised to submit all the information is true and effective, and assume all legal responsibilities. At the same time, to ensure consistent compliance with the requirements of the medical device quality management practices, in accordance with laws and regulations in the medical equipment business.
Legal representative or head of the enterprise (signature) (seal of the enterprise)
