Scope of clinical trial: it has not appeared in China market, or its safety and effectiveness are to be determined.
Confirmed medical devices.
Scope of clinical verification: Similar products have been listed in China, and the safety and effectiveness need to be improved.
Step by step confirmation of medical devices
Medical devices entering clinical trials shall meet the following conditions:
(1) Having registered product standards reviewed by the pharmaceutical supervisory and administrative department or the corresponding country.
, industry standards;
(2) Having a qualified type test report;
(three) the need for clinical trials of the third class of medical devices implanted in the human body, such as the inclusion must first
Animal test projects should be completed;
(4) Approved by the pharmaceutical supervisory and administrative department.
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