(A) with the production of medical equipment to adapt to the production site, environmental conditions, production equipment and professional and technical personnel;
(2) having the means or the full-time inspectors and the testing equipment for the quality inspection of the medical equipment produced;
(3) to ensure the quality of medical equipment management system;
(D) have the ability to adapt to the production of medical equipment after-sales service;
(5) meet the requirements of product development and production process documentation.
If the second and third categories of medical device manufacturers are to be established, they shall apply to the food and drug supervision and administration department of the province, autonomous region or municipality directly under the Central Government for the production license and submit the following information:
(1) a copy of the business license and organization code certificate;
(2) a copy of the registration certificate and product technical requirements for the medical device produced by the enterprise;
(3) a copy of the legal representative and the identity certificate of the person in charge of the enterprise;
(4) a copy of the identity, education and title of production, quality and technical person in charge;
(5) production management, quality inspection positions practitioners qualifications, title list;
(6) the production site of the document, a special production environment requirements should also be submitted facilities, orthopedic equipment manufacturers copy of the proof of the environment;
(7) Main production equipment and inspection equipment catalog;
(8) quality manuals and procedural documents;
(9) process flow chart;
(10) the certificate of authorization of the manager;
(11) Other proof information.
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