Taobao sell disposable medical masks sales qualifications needed to determine the classification of the medical masks, belonging to a class of medical devices masks, the need for a business license, belonging to the second class of medical devices masks, the need for a business license and the second class of medical devices business filing certificate.
1, Class II medical filing, legally sell masks.
2, Class II medical device network filing, online sales.
3, business license, account opening license.
4, the company's business scope: mask sales or sales of Class II medical devices.
5, do the import and export of goods, to apply for import and export license.
6, exported abroad also need to handle foreign currency accounts.
1, cotton gauze masks: can stop part of the virus attack, but with the human face poorly closed, anti-virus efficiency is low.
2, medical surgical mask: divided into three layers, the outer layer of water-blocking, the middle layer of air blocking 5μm particles greater than 90%, the inner layer of moisture absorption.
3, N95 medical protective masks: N95 is the U.S. Occupational Safety and Health Research Institute certification. N refers to non-oily particulate matter, 95 refers to the standard testing conditions in the filtration rate of 95%, with a good fit.
According to the "daily supervision and management of medical equipment production regulations" State Food and Drug Administration Measures [2006] No. 19 provisions of the medical mask products (medical protective masks, medical surgical masks and general medical masks) has been included in the "National Key Regulatory Medical Devices Catalog" and medical masks belong to the second class of medical devices.
According to the Regulations for the Supervision and Administration of Medical Devices for Class II Medical Devices, in addition to the basic qualifications of the company and the brand, you need to provide the "Class II Medical Devices Business Record Certificate" issued by the medical device regulatory department (for distribution enterprises), "Medical Device Manufacturer's License" (for manufacturing enterprises) and the corresponding "Medical Device Registration Certificate" of the mask product. The corresponding "Medical Device Registration Certificate", otherwise sales are prohibited.
At present, masks with a mechanical name (printed on the packaging and instructions of the goods with a mechanical certificate number) are only allowed to be sold in the relevant categories of medical devices (medicine and health care & gt; nursing care & gt; masks).