Masks belong to the second class of medical devices for the record, including common protective clothing, thermometer, non-human implantation belongs to the 2 class of medical devices, for the second class of medical medical devices can be.
The formalities to be handled: a copy of the business license and organization code certificate; legal representative, the person in charge of the enterprise, the person in charge of the quality of the identity, education or title certificate copy; organization and departmental setup description; scope of business, business mode description.
Business premises, warehouse address geographic location map, floor plan, documents proving property rights or lease agreement (with documents proving property rights) copies; business facilities, equipment directory; business quality management system, work procedures and other documents directory; computer information management system basic information and functional description; authorization of the operator to prove that the other supporting materials.
Processing time: 10 working days approval department: the location of the food and drug supervision and management department with licensing jurisdiction to apply for administrative licenses according to law.
kn95 and n95 mask what is the difference?
KN95 masks and N95 masks are not very different, mainly masks testing standards are different. KN95 masks follow the Chinese testing standards, N95 masks are to follow the U.S. testing standards.