I. Processing conditions:
(1) holds the medical device registration certificate of this enterprise.
(2) Having a production site, environmental conditions, production equipment and professional and technical personnel suitable for the medical devices produced; An enterprise shall have production equipment, production storage places and environment suitable for its products and production scale. Enterprises that produce medical devices with special requirements for environment and equipment shall comply with national standards, industry standards and relevant state regulations;
(3) Having institutions or full-time inspectors and inspection equipment for the quality inspection of medical devices produced; The person in charge of production, quality and technology of an enterprise shall have the professional ability suitable for the medical devices produced, master the laws, regulations and rules of the state on the supervision and management of medical devices and the provisions on the quality and technology of related products, and the person in charge of quality shall not concurrently be the person in charge of production;
(4) There is a management system to ensure the quality of medical devices;
(5) Having the ability of after-sales service suitable for the medical devices produced;
(6) Meet the requirements of product development and production process documents;
(7) The enterprise shall keep the laws, regulations, rules and relevant technical standards related to the production and operation of medical devices.