Opening a class I medical device manufacturing enterprises, 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 "Class I Medical Device Manufacturing Enterprises 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 technology responsible person shall have with the production of medical devices appropriate professional competence, and master the national supervision and management of medical devices related laws, rules and regulations, as well as related product quality, technology. The person in charge of quality shall not be concurrently in charge of 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 should have with the products produced and the scale of production and production of equipment, production, warehousing sites and the environment. Enterprises producing medical devices have special requirements for the environment and equipment, etc., should be in line with national standards, industry standards and relevant state regulations;
(d) the enterprise should set up a quality inspection organization, and with the production of varieties and production scale of the quality inspection capabilities;
(e) the enterprise should be preserved with the production and operation of medical devices related to the laws, rules and regulations, rules and relevant technical standards.