According to China's medical and health supplies allocation standards, China currently has the following three main types of masks, respectively: the first, medical device management masks; the second, labor protection masks; and the third, daily protection masks. When producing different types of masks, manufacturers need different production documents. First, the production of medical device management masks, you need documents for: medical device product registration certificate and medical device production license; second, the production of labor protection masks, also called special labor protective equipment, you need documents for: industrial production license and special labor protective equipment safety mark; third, the production of daily protective masks, do not need to apply for any license.
Legal objective:"Supervision and management of the production of medical devices" Article 7 to engage in the production of medical devices, should have the following conditions: (a) with the production of medical devices and the production of appropriate production sites, environmental conditions, production equipment, and professional and technical personnel; (b) there is the production of medical devices for the production of quality inspection organizations or full-time inspectors and inspection equipment; (c) there is a guarantee of medical device quality. (C) have to ensure the quality of medical devices management system; (D) with the production of medical devices compatible with the after-sales service capabilities; (E) meet the requirements of product development, production process documentation. Article 8 to start the second class, the third class of medical device manufacturers, shall apply to the local provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration for production permits, and submit the following information: (a) a copy of business license; (b) the applicant company holds a copy of the certificate of registration of the production of medical devices and the technical requirements of the product; (c) legal representative, the person in charge of the enterprise a copy of the identity of the person in charge of the production of medical equipment; (d) the Production, quality and technical personnel in charge of the identity, education, a copy of the title certificate; (E) production management, quality inspection positions practitioners list of education, title; (F) the production site of the supporting documents, there are special production environmental requirements should also be submitted to the facilities, environment, a copy of the supporting documents; (VII) the main production equipment and inspection equipment catalog; (VIII) quality manuals and procedural documents; (IX) Process flow diagrams; (J) proof of authorization of the operator; (K) other supporting information.