The real world of clinical trials for medical devices in China: understanding the regulatory nuances and the culture

摘要

To take a medical device through China's regulatory approval process requires a thorough understanding of the nuances and timings associated with the State Food and Drug Administration's clinical trial requirements, the agency's culture and its emphasis on patient protection and risk-benefit considerations.While the SFDA requirements are well-documented, it is important to be aware of how best to address this guidance and, thereby, minimise delays.The article focuses on the key steps and actions that can lead to a smoother approach to fulfilling China's requirements for starting a clinical trial for medical devices. Its purpose is to provide insights into the relationships between the goals of the manufacturer; the SFDA Testing Institute, the SFDA Center for Medical Device Evaluation (CMDE),the principal investigator, the ethics committees, subject protection and institutional expectations leading to the clinical trial itself. It also discusses the various approaches to statistical models that would be acceptable for meeting the SFDA requirements for support of the efficacy and safety of a medical device.