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How much is a disposable medical mask How much is it?
1, Class II medical record, legally selling masks.
2. Online filing and online sales of Class II medical devices.
3. Business license and account opening permit.
4. Business scope of the company: selling masks or selling second-class medical devices.
To import and export goods, you must apply for import and export rights.
6. Exporting countries also need foreign currency accounts.
1, cotton gauze mask: it can prevent some viruses from invading, but it has poor tightness with human face and low anti-virus efficiency.
2. Medical surgical mask: divided into three layers, the outer layer blocks water, the middle layer blocks more than 90% of 5μm particles in the air, and the inner layer absorbs moisture.
3.N95 medical protective mask: N95 has passed the certification of American Occupational Safety and Health Association. N means non-oily particles, and 95 means that the filtration rate reaches 95% and the sealing performance is good under the detection conditions specified in the standard.
According to the Regulations on Daily Supervision and Management of Medical Device Production (US Food and Drug Administration [2006] 19), medical mask products (medical protective masks, medical surgical masks and general medical masks) have been listed in the Catalogue of Medical Devices under State Key Supervision, and medical masks belong to the second category of medical devices.
According to the Regulation on the Supervision and Administration of Medical Devices on Class II medical devices, in order to sell medical mask products, in addition to providing the basic qualifications of the company and brand, it is also necessary to provide the registration certificate of Class II medical devices issued by the medical device supervision department (applicable to distribution enterprises), the License for Medical Device Manufacturing Enterprises (applicable to production enterprises) and the medical device registration certificate corresponding to the mask products, otherwise, sales are prohibited.
At present, it is only allowed to sell masks with mechanical numbers (printed on the product packaging and instructions) in medical device-related categories (medical care >: nursing protective gear > masks).
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