How to apply for the second class of medical devices business filing vouchers?

Now the medical device business license is divided into Class II medical device business filing, Class III medical device business license, specifically in accordance with the "supervision and management of medical equipment business approach to Order No. 8," Article VIII

The list of information to be provided is as follows:

(a) a copy of the business license and the organization code certificate;

(b) legal representative, the person in charge of the enterprise, Quality person in charge of identity, education or title certificate copies;

(C) organization and departmental setup description;

(D) the scope of business, business mode description;

(E) business premises, warehouse address of the geographic location of the map, floor plan, documents proving ownership of the house or lease agreement (with documents proving ownership of the house) copies;

(F) business facilities, equipment directory;

(G) business quality management system, work procedures and other documents directory;

(H) computer information management system basic information and functional description;

(IX) proof of authorization by the operator;

(X) other supporting materials.

Article XII engaged in the second class of medical devices business, the business enterprise shall be located in the district municipal food and drug supervision and management department for the record, fill out the second class of medical devices business filing form, and submit the information provided for in Article 8 of these Measures (except for the eighth item).

If you can help you, you can ask me, the specific requirements can look at the local Drug Administration's guide

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