Guidelines for Design of Medical Device Clinical Trial(Draft for Comment)

Updated: 2017/11/23

I. Applicable Scope

Medical device clinical trial refers to the process of verifying or validating the safety and effectiveness of medical devices proposed for registration under conditions of normal use in appropriately qualified clinical trial institutions. This Guidelines is applicable for medical devices with defined product composition, design and performance, including products for treatment and products for diagnosis but not in-vitro diagnostic reagents. This Guidelines does not apply to clinical trial design of customized devices and design for feasibility trial with small sample size.

II. Principles on Conduct of Clinical Trial

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