8th November, 2017
In order to improve the design of clinical trials of medical devices in the country, the Center for Medical Device Evaluation (CMDE) drafted the guidelines for the design of clinical trials of medical devices, and asked for the public’s opinion.
The guideline is applicable to the medical devices that possess clear product composition, design and performance, such as therapeutic or diagnostic devices, but not including the in-vitro diagnostic reagents. This guideline is not applicable to the clinical trials for customized medical devices and the small-scale clinical trials for the determination of the feasibility of a device.
This guideline contains the following: Scope, Clinical Trials Conduct Principles and Characteristics for Medical Devices, Subject, Primary and Secondary Endpoints, Categories (Types) of Comparison and Hypotheses of the Clinical Trial, Sample Sizes, Statistical Analysis and the Protocol Violation and Deviation of Clinical Trial.