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Abstract:
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In China, the State Food and Drug Administration (SFDA) is the primary agency responsible for regulating medical devices. Presently, there is no statistical guideline for medical devices regulation. However, SFDA pays particular attention to statistics, especially for class III Medical Devices---including implants, life support systems, and devices posing potential risk to the human body---which are controlled strictly for safety and effectiveness. Usually, the Medical Device Evaluation Center of SFDA invites trial statisticians to attend the technical review meeting of a new medical device. The trial statistician will evaluate the device clinical trial for study design, sample size, power, efficacy, and safety. Sponsors tend to cooperate with the trial statistician from the beginning to the end of a trial. Statistics is playing an increasingly more important role in device regulation.
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