Antigen test strip license classification

Antigen test paper license classification:

1, different risk levels. The first category is a low degree of risk, the implementation of routine management can ensure its safety and effectiveness of medical devices.

2, the second category is a moderate risk, need to strictly control the management to ensure its safety, effective medical devices. Such as: thermometer, sphygmomanometer, hearing aids, oxygen concentrator, condoms, constant temperature incubator, dental comprehensive treatment instrument, medical cotton wool, medical cotton wool.

3, the third category is a higher risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices. Such as: gene sequencer, medical ventilator, medical endoscopy, CT machine.