To produce medical masks, it is also necessary to apply for the Medical Device Product Registration Certificate and the Medical Device Production License from the Device Department of the US Food and Drug Administration.
The production of masks requires the following procedures:
1. Apply to the administrative department for industry and commerce for the company's business license;
2. Engraving the company seal according to law;
3. Open a bank account;
4. Handling tax registration;
5. Apply for a mask production license;
6, and according to the law for health permits.
Mask is a kind of sanitary product, which is usually worn on the nose and mouth to filter the air entering the nose and mouth to block harmful gases, smells, droplets, viruses and other substances. It is made of gauze or paper.
Masks have a certain filtering effect on the air entering the lungs. Wearing a mask has a very good effect when respiratory infectious diseases are prevalent and when working in polluted environments such as dust. Masks can be divided into air filtration masks and air supply masks.
Provisions on Hygiene License for Production Enterprises in disinfection products Article 2 Units and individuals engaged in disinfection products production and sub-packaging within the territory of China must apply for the Hygiene License for Production Enterprises in disinfection products (hereinafter referred to as the Hygiene License) in accordance with the requirements of these Provisions.
A production enterprise in disinfection products has a production site and a license. If a group or company owns more than one production site, it shall apply for a hygiene license separately.
Article 5 Units and individuals (hereinafter referred to as applicants) who apply for the hygiene license of production enterprises in disinfection products shall apply to the provincial health administrative department where the production site is located, submit the following materials, be responsible for its authenticity and bear corresponding legal responsibilities:
(1) An application form for hygiene license of production enterprises in disinfection products;
(two) a copy of the industrial and commercial business license or a notice of pre-approval of the enterprise name;
(3) Certificate of use of the production site (certificate of property right or lease agreement);
(four) the floor plan of the production site and the floor plan of the production workshop;
(five) the production process flow chart;
(6) List of production and inspection equipment;
(seven) quality assurance system documents;
(8) Catalogue of products to be produced;
(nine) production environment and production water test report;
(ten) other materials required by the provincial health administrative department.
The application materials shall be provided in accordance with the requirements and format of Annex 1.