According to the "supervision and management of the production of medical devices"
Article VI to open the first class of medical device manufacturing enterprises, should have the production of products with the production of appropriate production conditions and should be in the receipt of the business license within 30 days after filling out the "first class of Medical Device Manufacturer Registration", to the local province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department in writing.
Article VII 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 the production of medical devices and the production of appropriate professional competence, and to master the national supervision and management of medical devices, laws, rules and regulations, as well as related product quality, technology 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 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.
Article VIII to open the third class of medical device manufacturers, in addition to should meet the requirements of Article 7 of these measures
, should also have the following conditions:
(a) meet the requirements of the quality management system of the internal auditor not less than two;
(b) the relevant professional title above the intermediate level or college education of the full-time technical staff of not less than two.
According to the "Medical Device Business License Management Measures"
Article 6 The application for the "Medical Device Business License" shall have the following conditions:
(a) with the scale of operation and business scope of the quality management organization or full-time quality management personnel. Quality management personnel should have a nationally recognized professional qualifications or titles;
(B) with the scale and scope of operation of relatively independent premises;
(C) with the scale and scope of operation of storage conditions, including storage facilities, equipment, in line with the requirements of the characteristics of medical equipment products;
(D) should be (D) should establish and improve the product quality management system, including procurement, purchase and acceptance, warehousing and storage, out of the warehouse review, quality tracking system and adverse event reporting system;
(E) should have the appropriate technical training and after-sales service with its business medical device products, or agreed to provide technical support by a third party.
Article VII of the application for "medical device business license" must be through the (food) drug supervision and management department's inspection and acceptance.
Provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management departments should be based on this approach, combined with the actual situation in the jurisdiction, the development of medical equipment business inspection and acceptance standards, reported to the State Food and Drug Administration for the record.
Article VIII "medical device business license" set out the business scope should be in accordance with the medical device classification directory of the management category, class code name to determine.