What procedures are needed to produce masks what qualifications

1, as a medical device management masks, such as: medical protective masks, disposable general medical masks; medical surgical masks, medical masks are mainly these three. Production of such products, you need to apply to the provincial Food and Drug Administration Instrumentation Division for medical device product registration certificate ", medical device production license", are currently required more than 100,000 clean room, and have the ability to microbiological testing and related physical and chemical testing capabilities.

2, labor masks (special labor protective equipment), you need to apply to the provincial Technical Supervision Bureau of industrial production license, and to the State Administration of Work Safety to apply for special labor protective equipment safety mark certification (LA certification).

3, daily protective masks, this is relatively simple, do not have to apply for any license, the product to a qualified third-party testing organizations in accordance with the appropriate standards to send inspection, to obtain a qualified test report, you can go on sale.

One, what qualifications do mask factory

(a), the person in charge of the enterprise should have a secondary school education or above, or more than junior title.

(ii), the person in charge of the quality inspection organization should have college education or above or intermediate or above title.

(c), the enterprise should occupy the corresponding proportion of the total number of workers in the junior title or above engineering and technical personnel.

(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.

(viii), the production of sterile medical devices, should have a production site in line with the provisions.

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 certificate, and then apply for a disposable medical device production filing credentials; if the production of Class II medical devices masks, you need to apply for the registration of Class II medical device credentials, and then apply for a class of medical device production certificate. Medical device production certificate.

Legal basis

"Regulations for the Supervision and Administration of Medical Devices"

Article 20 Engaged in the production of medical devices, shall have the following conditions:

(a) with the production of medical devices compatible with the production site, environmental conditions, production equipment, as well as professional and technical personnel;

(ii) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment;

(c) 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) product development, production process documentation requirements.