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Type of medical device

Aug 31, 2019

The state implements classified management of medical devices according to the degree of risk.


The first category is the low level of risk, and the implementation of routine management can ensure its safe and effective medical equipment.


The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness.


The third category is medical devices that have high risks and require special measures to strictly control management to ensure their safety and effectiveness.


The purpose is to diagnose, prevent, monitor, treat or alleviate the disease; diagnose, monitor, treat, relieve or compensate for the damage; test, replace, regulate or support the physiological structure or physiological process; support or maintain life; pregnancy control; Provide information for medical or diagnostic purposes by examining samples from the human body.