Is a blood glucose meter a medical device? Do I need a license to sell blood glucose meters?

Blood glucose meter belongs to medical devices, and is a Class II device, but the sale of home blood glucose meter does not require a license to operate (State Food and Drug Administration City [2005] No. 239 in the text of the provisions). \x0d\\\\x0d\\Annex: The first batch of Class II medical device products that do not need to apply for a Medical Device Operator's License Class Code Name Product Name \x0d\\ General Diagnostic Instruments thermometers, sphygmomanometers Physiotherapy Devices Magnetic Therapeutic Apparatus \x0d\\Medical Sanitary Materials and Dressings Medical Degreased Cotton, Medical Degreased Gauze, Medical Hygienic Mouthpieces Clinical Laboratory Analytical Instruments \x0d\Home Use Blood glucose meter, blood glucose test strips, pregnancy diagnostic test strips (early and early pregnancy test side test strips)