The difference between Class I, Class II, and Class III medical devices
1. Classification of medical devices:
The first category refers to medical devices whose safety and effectiveness can be guaranteed through routine management.
The second category refers to medical devices whose safety and effectiveness should be controlled.
The third category refers to medical devices that are implanted in the human body; used to support and maintain life; have potential dangers to the human body, and their safety and effectiveness must be strictly controlled.
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