(a) with the production of medical devices and production sites, environmental conditions, production equipment and professional and technical personnel;
(b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment;
(c) have to ensure that the quality of medical devices Management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the product development, production process documentation requirements.
The opening of the second and third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for production permits, and submit the following information:
(a) a copy of the business license, organization code certificate;
(b) the applicant company holds a copy of the registration certificate of the medical device produced and 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, qualifications, titles, copies of certificates;
(E) production and management, quality inspection jobs practitioners qualifications, titles list;
(F) the production site of the documents, there are special requirements for the production environment Should also submit a copy of the facilities, environmental documents;
(vii) the main production equipment and inspection equipment directory;
(viii) quality manuals and procedural documents;
(ix) process flow diagrams;
(j) proof of authorization of the operator;
(xi) other supporting information.