Medical device license level are respectively what , please god Details

Medical devices according to the risk level is divided into I, II, III three management categories, of which Class III is the highest; at the same time, according to the different intended use, but also divided into different product categories, very much, from 6801 to 6877, product categories are also divided into specific varieties, for example: "single-use sterile syringe" is categorized as Class III-6815 injection and puncture instruments

Medical device licenses, mainly by the following types:

1, medical device license: business (sales of products produced by others) Class III and the vast majority of Class II medical devices, must obtain a license to operate in advance, but it is not to say that the license to operate on the sale of all categories of medical devices, you must see It is necessary to look at the major categories approved on the business license. If the category approved on the business license is Class III medical magnetic **** vibration equipment, you can not operate "single-use sterile syringes", although they are Class III, but the medical magnetic **** vibration equipment belongs to the 6828.

2, the medical device production license: the production of Class III and Class II medical devices, must obtain a production license in advance, and the majority of Class II medical devices, the production license must be obtained in advance, and the production of medical devices. The production license must be obtained in advance, and the same as the business license, but also not with a production license can produce all medical devices, the law is the same as above.

Additionally, only the license is not enough, medical equipment products in order to legally sell, there must also be a product registration certificate (issued for specific products), which you may not be interested in, not to say more.