Mask purchases need product filing?
Personal purchase and use is not required to record, if you are a business sales is required, because the medical mask belongs to the national class II medical devices, business implementation of record management. If you need to sell online, according to the "supervision and management of the sale of medical devices network approach" for the record of network transactions.
What qualifications are needed to sell n95 masks?
The n95 mask is a Class II medical device, and the sale of n95 masks requires a drug license and a medical device license.
After obtaining the administrative license, you also need to apply to the registration authority to obtain a business license before you can engage in n95 mask sales business activities.
Masks mechanical and consumer name?
The difference between the n95 mask and the mechanical name is:
1, the role of different ways: the n95 mask through the chemical way to the human body or objects, air, etc.; mechanical name mask is through the physical way to produce the effect, does not contain plants or drugs.
2, the role of different scopes: the mask can only be used for disinfection and sterilization, kill pathogenic microorganisms, does not have to regulate the physiological function of the human body efficacy, and must be remembered that can not appear or implied therapeutic effects. Measurement of the mask is directly or indirectly used for human instruments, equipment, apparatus, in vitro diagnostic reagents and calibrators, materials and other similar or related items.
3, the declaration costs and cycle is different: the declaration cycle of the consumer mask is about 2 to 3 months, the cost is generally not more than 10,000, do not need to do clinical trials. Measurement of the mask is divided into a class, two categories, three categories, the degree of difficulty in reporting from low to high. Second, three categories need to do clinical trials, a direct manufacturer can be filed, the specific costs and time to decide according to the actual situation.
Masks belong to which category?
The mask belongs to the protective supplies, medical protection, dust protection, cold protection, it has a variety of materials, gauze, polypropylene. Now in this time of viral ravages, this kind of protection is even more essential.