Hello, according to Article 4 of the Measures for the Supervision and Administration of Medical Device Operation, the operation of Class II medical devices is subject to record management. The filing process of Class II medical devices in Shenzhen.

Longhua Class II medical device business filing department

should file with the local municipal food and drug supervision and administration department.

the legal time limit for the filing of Longhua Class II medical devices

If the filing materials are complete and meet the requirements of formal examination, it shall be filed.

On-site verification of the business record of medical devices of Class II

The municipal food and drug supervision and administration department with districts shall conduct on-site verification of medical device business enterprises of Class II in accordance with the requirements of the quality management standards for medical device business within 3 months from the date of filing.

Requirements for the filing application materials of Longhua Class II medical device business

Precautions for Longhua Class II medical device business filing

(1) For this matter, when filling in the filing application online, you can use the online signature of "one legal person, one certificate".

(2) The chain stores only retail 19 varieties, so they can uniformly handle the second-class filing of the stores within their jurisdiction, list the stores within their jurisdiction, and provide one copy of the same materials (avoiding repeated submission).

(3) According to the Classification Catalogue of Medical Devices, we must pay special attention to the product category, business scope and classification code. Especially in the transitional period between the old and new Classified Catalogue, the information on the registration certificate provided by the supplier may be the contents of the old Classified Catalogue.

(4) The application materials should be complete, clear and accurate, and the altered parts should be stamped or signed. If signature is required, it should be signed, stamped with the official seal of the enterprise, printed or copied on A4 paper, and bound into volumes in the order of the application materials;

(5) Where a photocopy of the application materials is required, the applicant shall sign the photocopy for confirmation (this copy is the same as the original), indicate the date and affix the official seal of the enterprise;

(6) The application materials shall be in Chinese, and the application materials translated from foreign materials shall be accompanied by the original text.