By the impact of the recent epidemic, people on medical masks and other epidemic prevention items demand has increased, there are many entrepreneurs in the scope of business to increase the operation of medical masks and disinfectants and other epidemic prevention items, and today, a small editorial is mainly for you to organize is about the content of the operation of medical masks. Operating medical masks need to apply for what qualifications? What materials need to submit? Next with the editor together to take a look at it.
What qualifications are needed to operate medical masks?
What is called medical mask?
Medical masks are a kind of medical protective textiles, mostly made of one layer or multi-layer nonwoven composite, the main production processes include meltblown, spunbond, hot air or needle punching, etc., with resistance to liquids, filtering particles and bacteria and other utility. According to its performance characteristics and scope of application, medical masks can also be divided into medical protective masks, medical surgical masks and general medical masks.
What qualifications are needed to operate medical masks?
Want to know what qualifications are needed to operate, you need to first understand the medical masks belong to several classes of medical devices. If the medical mask belongs to the second class of medical devices, the business needs to be filed, belongs to the third class of medical devices need to apply for the relevant license, and belongs to a class of medical devices, only need to add the relevant business items in the scope of business can be.
So, medical masks belong to several categories of medical devices? Because medical masks have the effect of resisting liquid, filtering particles and bacteria, and in order to ensure that medical masks have a clear isolation role, to ensure its effectiveness, the state generally included in the second class of medical devices. That is to say, enterprises operating medical masks are required to apply for Class II medical device business record. If the enterprise has involved in import and export trade, also need to handle the relevant import and export business qualification.
General filing of the materials required to be submitted are:
1. Class II medical device business filing form and a copy of the business license;
2. Legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity of the person in charge of a copy of the certificate of qualifications or titles;
3. Organizational and departmental setup description, scope of business, business mode of description;
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4. Business premises, warehouse address location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copy (different regions of the business premises area requirements also vary);
5. Business facilities, equipment directory, business quality management system, working procedures and other documents directory, as well as other supporting materials.