Medical device products according to the risk program will be divided into three categories:
1, Class I medical devices, low-risk, the implementation of routine management can ensure its safety and effectiveness of medical devices;
2, Class II medical devices, with moderate risk, need to be strictly controlled by the management in order to ensure the safety and effectiveness of medical devices;
3, Class III medical devices, with a high risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices.
Two, analysis of the details
The determination of the classification of medical devices need to take into account the intended use of the product, structural features and methods of use, and based on the rules of classification of medical devices, classification directory and the existing product standards, etc., and, if necessary, you can also apply for the classification of the definition of the application, food and drug supervision and management department will organize experts to submit an application for the analysis of the product and categorization.
Three, a class two class three medical device difference
The first class of medical devices is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices, such as scalpels, surgical scissors, manual beds, medical ice packs, cooling pads, and so on, its products and production activities by the municipal food and drug regulatory departments of the location of the municipal level of the implementation of record management. Business activities are all liberalized, neither permit nor record, only need to obtain a business license issued by the business sector. The second class of medical devices is a medium risk, need to strictly control the management to ensure the safety and effectiveness of medical devices, such as band-aids, condoms, thermometers, sphygmomanometers, oxygen concentrators, nebulizers and so on, which are common in our daily life. The third category of medical devices is a higher risk, need to take special measures to strictly control the management to ensure its safety and effectiveness of medical devices, such as common infusion sets, syringes, intravenous needles, cardiac stents, respiratory machines, CT, nuclear magnetic **** vibration and so on.