The following conditions must be met in order to start a Class II medical device manufacturing enterprise:
(a) The person in charge of the enterprise shall have a college degree or above or a junior title or above.
(B) the person in charge of the quality inspection organization should have a college degree or above, or intermediate title or above.
(C) the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
(d) the enterprise should have the appropriate product quality inspection capabilities.
(E) should be compatible with the production of products and scale of production, warehousing sites and environment.
(F) has the appropriate production equipment.
(vii) The enterprise shall collect and save the laws, regulations, rules and relevant technical standards related to the production and operation of the enterprise.
(viii) the production of sterile medical devices, should have a production site in line with the provisions.
Extended informationThe first class of medical device products for the record and apply for registration of the second and third class of medical device products, the following information should be submitted:
(a) product risk analysis information;
(b) product technical requirements;
(c) product inspection reports;
(d) clinical evaluation information;
(e) Product specifications and labeling samples;
(F) and product development, production and quality management system documents;
(G) to prove that the product is safe, effective and other information required.
The applicant for registration of medical devices, the filer shall be responsible for the authenticity of the information submitted.
Baidu Encyclopedia - Class II Medical Devices
Baidu Encyclopedia - Medical Devices