What are the requirements for the personnel needed to start a medical device manufacturing company? Please 3Q
Eighteen years of age or older, with relevant technical experience, the appropriate qualifications and capabilities, but also science and technology professionals can According to the "supervision and management of the production of medical devices" Article 6 to open the first class of medical device manufacturers, should have with the production of products suitable for the production of conditions, and should be in the receipt of the business license within 30 days, fill out the "first class of medical devices manufacturer registration" to the location of the province, Autonomous regions, municipalities directly under the Central (food) Drug Administration in writing. Article 7 to open the second, third class medical device manufacturers must have the following conditions: (a) the enterprise's production, quality and technical personnel should have with the production of medical devices and the production of appropriate professional competence, and to master the national supervision and management of medical devices and the laws, rules and regulations of the product quality and technology provisions of the product. 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 in line with national standards, industry standards and relevant state regulations; (D) enterprises should set up quality inspection organizations, and with the production of varieties and production scale of quality inspection capabilities; (E) enterprises should be preserved with the production and operation of medical devices related laws, regulations, rules and relevant technical standards. Want to know more you can find Ao Zi Da medical device consulting company, this company is very professional knowledge of medical devices.