Legal analysis: 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. The production documents required by the manufacturers to produce different types of masks are different.
First, the production of medical device masks, need documents for: medical device product registration certificate and medical device production license;
Second, the production of labor masks, also called special labor protective equipment, need documents for: industrial production license and special labor protective equipment safety mark;
Third, the production of daily protective masks, do not have to handle any license.
Legal basis: "supervision and management of the production of medical devices" Article VII engaged 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 a production of medical devices for quality inspection of the organization or a full-time inspector As well as inspection equipment;
(C) have to ensure that the quality of medical devices management system;
(D) with the production of medical devices compatible with the after-sales service capabilities;
(E) in line with the product development, production process documentation requirements.
Article VIII to start the second class, the third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for production licenses, and submit the following information:
(a) a copy of the business license;
(b) the applicant company holds a copy of the certificate of registration of the production of medical devices and product technical requirements;
(C) legal representative, a copy of the identity of the person in charge of the enterprise;
(D) production, quality and technical personnel in charge of the identity of the person, education, title certificate copies;
(E) production management, quality inspection positions of practitioners, education, title lists;
(F) the production site of the supporting documents, there are special requirements for the production environment should be submitted to the Facilities, environment, copies of documents;
(vii) the main production equipment and inspection equipment directory;
(viii) quality manuals and procedural documents;
(ix) process flow diagrams;
(j) proof of authorization of the person in charge;
(xi) other supporting information.