Note: A class does not need to apply for a medical device production license, production record comprehensive general can be processed
Medical device production license for all of the following conditions, you can apply for:
(1) hold the enterprise's "medical device registration certificate"
(2) in line with the "Supervision and Administration of Medical Devices Regulations" Article 20, "Medical Devices Production Quality Management Standard" Article 9, Article 13 requirements, with the production of medical devices produced by the production site, environmental conditions, production equipment and professional and technical personnel; the enterprise should have with the production of products and production scale of production equipment, production, warehousing sites and environment. Enterprises producing medical devices on the environment and equipment and other special requirements, should be in line with the standards, industry standards and relevant regulations;
(3) in line with the "supervision and management of medical devices regulations" Article 20, "Code for the Quality Management of Medical Devices Production," Article 5, Article 8, Article 9, Article 21 requirements, there are production of medical devices for quality inspection of the organization or full-time inspectors As well as inspection equipment; enterprise production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and to master the supervision and management of medical devices and related laws, rules and regulations, as well as related product quality, technical regulations, the quality of the person in charge shall not be concurrently in charge of the production;
(4) in line with the "Supervision and Administration of Medical Devices Regulations", "Medical Devices", "Medical Devices", "Production Quality Management Standards", "24 to 21". Production Quality Management Standard", "the requirements of Articles 24 to 27, have to ensure that the quality of medical devices management system;
(5) in line with "supervision and management of medical devices regulations" Article 20, "Medical Device Manufacturing Quality Management Standard", Articles 62 to 66 requirements, and the production of medical devices and after-sales service capacity;
(6) in line with the "supervision and management of medical devices regulations" Article 20, "the requirements of Article 62 to 66, the requirements of Article 62 to 66, and after-sales service capacity Management Regulations" Article 20, "Medical Device Production Quality Management Standard" Article 28 to 38 requirements, in line with the product development, production process documentation requirements;
(7) enterprises should be preserved with the production and operation of medical devices related to laws, rules and regulations, regulations and relevant technical standards.