Do a production medical equipment factory, the factory needs to set up what file

Article VIII to open the second class, the third class of medical device manufacturers, shall apply to the local provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for production permits, and submit the following information:

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

(b) the applicant company holds the production of medical devices, the certificate of registration and a copy of the technical requirements of the product;

(C) legal representative, a copy of the identity of the person in charge of the enterprise;

(D) production, quality and technical personnel in charge of the identity, education, title certificates;

(E) production and management, quality inspection positions of practitioners, academic qualifications, titles list;

(F) the production site of the documents, there are special production environmental requirements should also be Should be submitted to the facilities, environment, copies of documents;

(vii) the main production equipment and inspection equipment directory;

(viii) quality manuals and procedural documents;

(ix) the process flow diagram;

(j) proof of authorization of the person in charge;

(xi) other supporting information.

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