The Rules for the Classification of Medical Devices are used to guide the development of the Classification Catalog of Medical Devices and to determine new product registration categories. China's implementation of medical device classification method is the classification rules under the guidance of the catalog classification system, classification rules and classification catalog coexist.
Referring to the internationally recognized classification, it is strictly controlled. The risk of use is the basis for the development of product classification catalog.
The gamma knife is a radionuclide diagnostic equipment, "Medical Device Classification Rules" the gamma knife is classified as a management category is 3 high-risk 6833 medical nuclide equipment.