January 8th 2018, China Food and Drug Administration (CFDA) issued announcement about 医疗器械临床试验设计指导原则.pdf.
Medical device clinical trials is a process that verify the safety and effectiveness of the CFDA registration applied medical devices under the normal operating conditions.
This guideline can apply to the medical device that the product composition, design and performance have been finalized. It including treatment products and diagnostic products but not include in vitro diagnostic reagent (IVD).
And this guideline focuses on the medical device clinical trial purpose, basic types and characteristics of clinical trial design, study subjects, evaluation index, sample size estimation and statistic analysis.
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