What qualifications are required for the production of medical surgical masks?
Posted by Admin
Under the influence of the epidemic, the supply of masks is in short supply and is very scarce. The price has also been fired to an abnormally high level. Many entrepreneurs saw business opportunities and wanted to invest in mask production lines to produce and sell masks. At the same time, the policy also strongly encourages and supports enterprises to produce medical protective materials such as masks.
What should I do if there is still a large gap in mask production?
Relevant policies provide support for enterprises to increase production and expand production capacity to produce more protective materials such as masks. "Please don't worry about it, and increase production in an all-round way."
At present, masks are mainly divided into three categories (the corresponding requirements are as follows):
1. Medical masks (medical protective masks, medical surgical masks, disposable medical masks), requirements: the business scope must have the production and sales of relevant medical masks, have a medical device production license, medical device registration certificate, corresponding standards or Industry standard test reports, such as gb19083-2010, yy0469-2011, etc. And it needs to have a clean workshop of more than 100,000 grades, as well as microbiological testing capabilities and related physical and chemical testing capabilities.
2. Labor protection masks, requirements: the business scope needs to have the production and sales of labor protection masks, the cancellation of industrial product production licenses, the cancellation of la certification, and the national standard gb2626-2006/2019 test report.
3. Requirements for daily protective masks: the business scope involves the production and sales of daily protective masks, and a qualified test report of the corresponding standard has been obtained, such as the national standard gb/t32610-2016.
After the outbreak, drug administrations in various regions quickly opened green channels for the registration and filing of medical mask products and new start-up companies, and approved them at a fast speed. At present, some companies that meet the conditions have obtained relevant qualifications. Enterprises applying for expedited approval must first obtain a letter from the Ministry of Industry and Information Technology and a qualified inspection report for the corresponding product implementation standards.
It is not difficult to produce masks, but it takes a lot of work to produce masks that meet the standards and industry standards. The process of applying for qualifications is also a way to test whether the quality of products produced by manufacturers meets the requirements of the standards.
Consumers are also requested to pay more attention when purchasing masks, and choose manufacturers with formal qualifications to purchase. There are many fake or shoddy or three-no product masks on the market, please pay more attention. Reminder: The use of substandard masks may result in poor protective effect or adverse reactions!