Hello, according to Article 4 of the "Measures for the Supervision and Administration of Medical Device Operations", the operation of Class II medical devices is subject to registration management. Shenzhen Class II medical device business registration process.

Longhua Class II Medical Device Business Registration Department

Should be registered with the local districted municipal food and drug administration department.

Longhua’s legal time limit for the registration of Class II medical device operations

If the registration materials are complete and meet the formal review requirements, they will be filed.

On-site verification of Class II medical device business registration

The districted municipal food and drug supervision and administration department shall, within 3 months from the date of registration of the medical device business enterprise, conduct According to the requirements of the equipment operation quality management regulations, on-site inspections should be carried out on Class II medical device operating enterprises.

Longhua Class II medical device business registration application material requirements

Longhua Class II medical device business registration matters needing attention

(1) For this matter, filing When filling out the application online, you can sign online by using the "One Pass for Legal Persons".

(2) Chain-operated stores only retail 19 varieties. They can uniformly handle the second-category registration of all stores in the jurisdiction, list the stores in the jurisdiction, and provide one copy of the same materials (to avoid repeated submissions) ).

(3) According to the implementation of the "Medical Device Classification Catalog", special attention must be paid to product categories, business scope, and classification codes. Especially during the transition period between the old and new Classification Catalogs, the information on the registration certificate provided by the supplier may be the content of the old version of the Classification Catalog.

(4) Application materials should be complete, clear, and accurate. Any alterations should be stamped or signed. If a signature is required, a signature must be affixed, stamped with the company's official seal, printed or copied on A4 paper, and bound in the order of the application materials. Complete the book;

(5) If a copy of the application materials is required, the applicant must sign and confirm the copy (this copy is the same as the original), indicate the date, and stamp the official seal of the company;

(6) The application materials should be in Chinese. If the application materials are translated based on foreign language materials, the original text should be provided at the same time.