On January 4, 2018, the China Food and Drug Administration (CFDA) released guidelines for the design of medical device clinical trials. The document covers the basics of clinical trials such as blinding and randomization, and goes into the more specific elements of trials that companies must consider. The text gives explanations of various study designs, the selection of primary and secondary endpoints, and the statistical aspects of creating rigorous trials. The new guidelines are part of China’s efforts to encourage innovation in medical devices while raising standards. The rules do not deal with administrative issues such as registration approval and are not enforced as statutory regulations.
