How to enter the face mask machine market

The most worrying thing about enterprises producing disposable medical masks is how to gain market access as soon as possible. Based on the current market situation, there are four paths:

1. Civil mask

Produce civilian masks in accordance with GB / T 32610-2016 "Technical Specifications of Daily Protective Masks", but at the same time the masks are also tested according to the standard of medical masks, and an inspection report from an authorized third-party inspection agency is obtained. In this way, the product packaging must not be claimed as a medical mask, nor need to apply for a medical device registration certificate, which can save time. But at the same time, the company inspects according to the standard of medical masks, which can ensure the quality of its masks, and can also be used for general protection of non-medical personnel.

2. Export to domestic sales

Local drug regulatory bureaus have released green channels for exporting medical devices for domestic sales. For companies that originally produced foreign standard masks for export and have the ability to produce domestic standard masks but have not obtained the relevant qualifications, these green notices can quickly obtain market approval To sell to medical institutions for urgent use.

3. Recording of production of emergency medical device products

Many non-medical device companies or companies that did not originally produce export masks also wanted to establish a mask production line. The difficulty will be a bit more difficult, but some drug regulatory bureaus have procedures for the production of emergency medical device products, which can help these companies quickly obtain product records, such as Jiangsu Province has such a policy. However, it is not easy for these enterprises to build a new production line and establish a basic quality management system to pass the on-site inspection by the Food and Drug Administration. Need to be instructed by personnel familiar with the medical device industry, and communicate closely with the drug regulatory personnel to make timely corrections.

Although this route and the "export to domestic sales" route are not difficult on the whole and the time is relatively short, the validity period of the record certificate obtained is not too long and can only be used during the epidemic.

4. Obtain the second-class medical device registration certificate

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