You don't need three certificates to buy medical masks. Only according to the classification of medical masks to determine the qualifications needed to sell medical masks. Those who belong to the first category of medical device masks need to have a business license. Those who belong to the second category of medical device masks need to have a business license and a record certificate for the operation of the second category of medical devices.
What documents do I need to sell n95 masks?
No need.
No special qualification license is required. Anti-particulate masks of KN95/N95 and above belong to non-medical masks, also known as civil masks, and the implementation standard is GB2626—2006. According to the Catalogue of Special Labor Protection Articles, these non-medical particle protection masks belong to special labor protection articles. The production and sale of non-medical masks do not need special qualification license like medical masks. According to the management of Class II medical devices, the production and operation of non-medical masks need to obtain the production qualification of licensed medical devices according to law, and operators should put on record and operate Class II medical devices.
What is the procedure for opening a Kn95 mask factory?
N95 mask belongs to the second category of medical devices, and its production qualification is audited and managed by the National Medical Products Supervision and Administration (NMPA). Therefore, the production of this kind of mask requires strict production qualification. If it is the production of medical devices, there must be a medical device production license or production record. If it does not produce, it only sells medical devices, and it must have a medical device business license or record.
Does the supermarket need to put on record to sell medical masks?
Need to be filed.
Supermarkets can't sell masks without obtaining medical device sales qualification.
Medical disposable protective clothing, medical protective masks and medical surgical masks all belong to the second category of medical devices;
Engaged in the second kind of medical device business, the business enterprise shall file with the food and drug supervision and administration department of the municipal people's government located in the district, and submit relevant certification materials that meet the requirements for engaging in medical device business activities.