Do individual businessmen need to apply for a Medical Device Operator's License to operate Class II and Class III medical devices? If so what is the legal basis?

The first do not need to apply for "medical equipment business license" of the second class of medical equipment product list

Class code name Product name

General diagnostic instruments thermometers, sphygmomanometers

Physiotherapy equipment Magnetic therapy apparatus

Medical hygiene materials and dressings medical cotton wool, cotton, medical debridement gauze, medical sanitary mask

Clinical testing and analysis instruments home blood glucose meter, blood glucose test strips, pregnancy diagnostic test strips (early pregnancy test side test strips)

Medical polymer materials and products condoms, contraceptive caps

Ward care equipment and appliances wheelchairs

Dressings medical sterile gauze

The third category is that it is necessary to apply for a license! The Medical Device License is not just for businesses