Two,
First of all, to give you a general knowledge of medical devices, according to the "supervision and management of medical devices regulations" Article VI of the State of medical devices in accordance with the degree of risk of implementation of the classification and management: the first class refers to, through routine management is sufficient to ensure the safety and efficacy of medical devices. Generally by the City Food and Drug Administration to approve, issued by the registration certificate. Its operation can not use the "Medical Device License", only need to register to the Industrial and Commercial Bureau.
For example: external hemostatic paste, medical cold compresses, acupoint pressure stimulation paste, cold gel, wound care ointment, liquid dressings, medical non-allergic breathable adhesive tape. It should be noted that not all "hemostatic patch" is a class, some are class II medical devices, some are chemical drugs, these products have to be based on the nature of its own decision. Class II refers to, on its safety, effectiveness should be controlled medical devices. Generally by the provincial Food and Drug Administration to approve, issue a registration certificate. For example: thermometer, sphygmomanometer, condoms (condoms) and so on.
Three, the state has been out of two batches do not need to apply for "medical device business license" of the second class of medical devices, the first batch of thirteen, the products are: thermometers, sphygmomanometers, medical cotton, medical cotton wool, medical cotton wool, medical sanitary masks, magnetic therapy appliances, home glucose meter, blood glucose test strips, pregnancy diagnostic test strips (pregnancy test strips), condoms, contraceptive caps, wheelchairs, medical sterile gauze.
The second batch of products that do not need to apply for the "Medical Device Operator License" are six: electronic blood pressure pulse meter, plum blossom needles, three pronged needles, acupuncture needles, ovulation detection test strips, hand-held oxygen generator. Class III refers to, implanted in the human body; used to support, maintain life; potentially dangerous to the human body, its safety, effectiveness must be strictly controlled medical devices. Generally by the State Food and Drug Administration to approve, issued by the registration certificate. However, the approval of a medical device in the end is classified into several categories in the side is not a lifelong, is determined by its safety, the State Bureau has the right to change its classification, such as masks in the general period are divided into a class, but in the period of SARS was classified as a class II! Specific medical device classification reference to our State Drug Administration issued the "Medical Device Classification Catalog":