Acceptance of overseas clinical trial data of medical devices for pre-market registration: general principles and considerations of the National Medical Products Administration

Abstract

Medical devices differ in mechanisms of action in or on the human body, type, and duration of contact with the human body, and expected clinical effects. [...]a medical device may have different risks and clinical performances across populations. The working mechanism is based on time-dependent changes in optical tissue properties caused by pulsatile flow. Since the operating principle involves the interaction between optical signals and tissues, issues related to melanin deposition should be considered. Specifically, the overseas subjects and Chinese target group may have differences in skin color. [...]a bridging clinical study may be needed. Otherwise, an explanation of methods for reducing or eliminating the influence caused by those differences, such as subgroup analyses of existing clinical trial data, or a supplementary clinical trial in the Chinese population, may be required. Ju S, Liu YH, Zhang YD, Wu CS, Xiao L, Sun L. Acceptance of overseas clinical trial data of medical devices for pre-market registration: general principles and considerations of the National Medical Products Administration.