Masks need what license

According to our country's medical and health supplies allocation standards, there are three main types of masks in China, namely:

the first, medical device management masks;

the second, labor masks;

and the third, daily protective masks.

Manufacturers need different documents to produce different types of masks.

First, the production of medical devices management masks, you 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, 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. 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 equipment quality inspection organizations or specialized staff. (B) the production of medical devices to carry out quality inspection of the organization or 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 capabilities;

(E) in line with the product development, production process documentation requirements.

Article VIII

open 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 application for the production of medical devices held by the company's certificate of registration and a copy of the 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, education, a copy of the title;

(e) production management, quality inspection positions of practitioners, education, title list;

(f) the production site of the documents, there are special requirements for production of the environment should also be submitted to the facilities, the environment of the copy of the documents;

(g) the application for the production of medical devices held by the company's registration certificate and product technical requirements;

(h) the production of medical devices;

(i) the application for the production of medical devices;

(ii) the application for the production of medical devices held by the company's registration certificate and the product technical requirements /p> (G) the main production equipment and inspection equipment directory;

(H) quality manuals and procedural documents;

(IX) process flow chart;

(X) proof of authorization of the operator;

(XI) other supporting information.