A. What qualifications are needed to run a mask factory (a), the person in charge of the enterprise should have a college education or junior title. (ii), the person in charge of the quality inspection agency should have college education or above or intermediate title. (c), the enterprise title of junior or above engineering and technical personnel should occupy the corresponding proportion of the total number of employees. (d), the enterprise should have the appropriate product quality inspection capabilities. (E), there should be with the production of products and scale of production, warehousing sites and environment. (F), with the appropriate production equipment. (vii), the enterprise should collect and save and enterprise production, business-related laws, regulations, rules and relevant technical standards. (h), the production of sterile medical devices, should have to comply with the provisions of the production site. "Supervision and Administration of Medical Devices Regulations" Article 20 engaged in the production of medical devices, should have the following conditions: (a) with the production of medical devices and production sites, environmental conditions, production equipment, and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of the organization or a full-time inspectors and inspection equipment; (C) have to ensure the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capacity; (E) product development, production process documentation requirements.
Two, what formalities are required to open the mask factory
mask production according to the type of masks need to apply for different documents, if the production of a class of medical devices class masks, you need to first apply for a class of medical device product registration, and then apply for a one-time medical device production filing credentials; if the production of Class II medical devices masks, you need to apply for a Class II medical device registration credentials, and then apply for a Class II medical device registration credentials, and then apply for a Class II medical device production filing credentials. The first two are the same, but the second is the same, but the third is the same. We can understand that the mask factory must meet certain requirements, and need to go through the relevant procedures, the law is relevant provisions, so that the factory is not so easy. These are the relevant content for you to organize, if there is any doubt, you can consult the relevant lawyers.