To start the first class of medical device manufacturers, should have with the production of products suitable for the production conditions, and should be in the receipt of business license within 30 days, fill out the "first class of medical devices manufacturer registration form" to the location of the provinces, autonomous regions and municipalities directly under the Central Government (food) drug supervision and management department informed in writing. Edit this section of the second class, the third class of medical device manufacturers (a) the enterprise's production, quality and technical personnel should have with the production of medical devices appropriate professional ability, and master the national supervision and management of medical devices related laws, rules and regulations and related product quality, technical provisions. The person in charge of quality shall not be concurrently responsible for the production;
(2) the enterprise above junior title or technical personnel with secondary education or above as a proportion of the total number of employees should be compatible with the requirements of the products produced;
(3) the enterprise shall have with the products produced and the scale of production and production of equipment, production, warehousing sites and the environment. 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 have 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 to laws, regulations, rules and regulations and the relevant technical standards. Relevant technical standards.