On January 8th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this document.
In this guidelines document, CFDA states that clinical trials of medical devices refer to the process of confirming the safety and effectiveness of medical devices intended for registration under normal conditions of use in clinical trial institutions that have the appropriate conditions. Clinical trials are based on the test population (sample), observe the effects of test equipment on the human body under normal conditions of use or evaluation of human disease, health status to infer the test equipment in the intended use of the population (overall) Effect. Due to the inherent characteristics of medical devices, their experimental design has its own characteristics.
This guideline applies to medical devices with a defined composition, design and performance profile, including therapeutic and diagnostic products, excluding in vitro diagnostic reagents.
The Guiding Principles are technical guidance documents for applicants and reviewers and do not deal with administrative matters such as registration approval. They are not enforced as statutory regulations. Other methods that meet regulatory requirements may also be used, but detailed guidance should be provided Research data and verification data. This guideline should be used subject to compliance with applicable regulations.
This newly released CFDA gives detailed and quantitative guidelines in these areas for medical device clinical trials:
To make the guidelines more usefaul, CFDA has also thoughtfully provided useful examples of test hypotheses and example of sample size estimation formula.
It is a must read for all device manufacturing companies who are currently doing or are planning to conduct clinical trials in China.