Article 4 The State implements classified management of medical devices according to the degree of risk.
The first category is low-risk medical devices, which can be guaranteed to be safe and effective through routine management.
The second category is medium-risk medical devices, which need strict control and management to ensure their safety and effectiveness.
The third category is high-risk medical devices, which need to be strictly controlled and managed by special measures to ensure their safety and effectiveness.
To evaluate the risk degree of medical devices, the expected use, structural characteristics and use methods of medical devices should be considered.
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