The first class of medical device manufacturers Open the first class of medical device manufacturers, should have the production of products compatible with the production conditions, and should be in the receipt of the business license within 30 days after the completion of the "first class of medical device manufacturer registration form" to the location of the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department informed in writing. Class II, Class III medical device manufacturers (a) the enterprise production, quality and technical personnel should have the production of medical devices and the production of appropriate professional competence, and master the national supervision and management of medical devices and the laws, rules and regulations and related product quality, technical regulations. The person in charge of quality shall not also serve as the person in charge of production; (b) the proportion of technical personnel with junior title or above or technical personnel with secondary education or above in the enterprise shall be compatible with the requirements of the products to be produced; (c) the enterprise shall have the production equipment, production, warehousing sites and environment that are compatible with the products to be produced and the scale of production. Enterprises producing medical devices with special requirements for the environment and equipment, should be in line with national standards, industry standards and relevant state regulations; (D) the enterprise should set up a quality inspection organization, and have with the production of varieties and production scale of quality inspection capabilities; (E) the enterprise should be preserved with the production and operation of medical devices related laws, rules and regulations and relevant technical standards. The opening of Class III medical device manufacturers, in addition to the above requirements should be met, should also have the following conditions: (a) meet the quality management system requirements of the internal auditor not less than two; (b) the relevant professional title above the intermediate level or college degree or above of full-time technical staff not less than two. Measures for the supervision and management of the production of medical devices Article 7 to engage in the production of medical devices, should have the following conditions: (a) with the production of medical devices and the production of suitable 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 a full-time inspectors and inspection equipment; (c) have to ensure the quality of medical devices management system; (d) with the production of medical devices, the quality 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. Article VIII to start the second class, the 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) business license, organization code certificate copies; (b) the applicant company holds the production of medical devices and product registration certificate and a copy of the technical requirements of copies of the product; (c) legal representative, the person in charge of the enterprise Identity Card (D) production, quality and technical personnel in charge of the identity, education, title certificate copies; (E) production management, quality inspection positions, staff education, title list; (F) production site documents, there are special requirements for the production environment should also be submitted to the facilities, environment, copies of documents; (G) the main production equipment and inspection equipment catalog; (H) quality manuals and program (Ix) process flow diagram; (J) proof of authorization of the operator; (K) other supporting information.
Legal Objective:"Supervision and Management of Medical Devices Production" Article 7 engaged in the production of medical devices, shall have the following conditions: (a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices for quality inspection of the organization or full-time inspectors and inspection equipment; (c) the quality of medical devices to ensure the quality of the production of medical devices. (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 capacity; (E) in line with the product development, production process documentation requirements.