Seek advice: what are the requirements for the production site of class III medical devices

Article VII to open the second class, the third class of medical device manufacturers must have the following conditions: (a) the enterprise's 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, laws, rules and regulations, as well as related product quality, technical provisions. The person in charge of quality shall not be concurrently 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 produced; (c) the enterprise shall have the production equipment, production, warehousing sites and environment that are compatible with the products produced and the scale of production. Enterprises producing medical devices on the environment and equipment and other special requirements, should be consistent with national standards, industry standards and relevant state regulations; (D) the enterprise shall set up a quality inspection organization, and have with the production of varieties and production scale of quality inspection capabilities; (E) the enterprise shall save the production and operation of medical devices and related laws, regulations, rules and relevant technical standards. Article VIII to open the third class of medical device manufacturers, in addition to the requirements of Article VII of these measures should also have the following conditions: (a) in line with the quality management system requirements of the internal auditor of not less than two; (b) the relevant professional title above the intermediate level or college degree or above full-time technical staff of not less than two. Article IX to open the second class, the third class of medical device manufacturers, should be the enterprise's location in the provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department to apply, fill out the "Medical Device Manufacturer License (start-up) Application Form" (see Annex 2 of these measures), and submit the following materials: (a) the legal representative, the person in charge of the enterprise's basic information and proof of qualifications; (b) the industrial and commercial administration issued by the name of the proposed enterprise (B) notification of pre-approval of the name of the proposed enterprise issued by the Administration for Industry and Commerce; (C) production site documents; (D) enterprise production, quality and technical personnel in charge of the curriculum vitae, academic qualifications or professional title certificates; the relevant professional and technical personnel, skilled workers registration form, and indicate the department and position; senior, intermediate, junior technical staff ratio table; (E) the scope of the products to be produced, the varieties and related products; (F) the main production equipment and inspection equipment inventory; (F) (F) the main production equipment and testing equipment catalog; (G) the production of quality management documents catalog; (H) the production of products to be produced by the process flow diagram, and indicate the main control items and control points; (IX) the production of sterile medical devices, should provide the production of environmental testing reports. The applicant shall be responsible for the authenticity of all the contents of its application materials.