The state has implemented categorized management of medical devices according to the degree of risk.
The first category is medical devices with a low degree of risk, the implementation of routine management can ensure their safety and effectiveness.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The drug supervision and management department of the state council is responsible for formulating the classification rules and classification directory of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the changes in the risk of medical devices, and adjust the classification rules and classification directory. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory should be published to the community.
Legal basis:
Regulations on the Supervision and Administration of Medical Devices Article 6 The state shall implement classification and management of medical devices in accordance with the degree of risk.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices, should take into account the intended purpose of the medical device, structural features, use and other factors.
The drug supervision and management department of the state council is responsible for formulating the classification rules and classification directory of medical devices, and according to the production, operation and use of medical devices, timely analysis and evaluation of the changes in the risk of medical devices, and adjust the classification rules and classification directory. The development and adjustment of classification rules and classification directory, should fully listen to the medical device registrant, filer, production and operation of enterprises, as well as the use of units, industry organizations, and reference to international medical device classification practice. Medical device classification rules and classification directory should be published to the community.