February 09, 2018
"The Guidelines for Accepting Overseas Clinical Data of Medical Devices" (hereinafter referred to as the "Guideline") was promulgated last January 11, 2018. CFDA has declared that they will be accepting overseas clinical trial data of devices registered in China.
This Guideline clearly outlines the policies of accepting overseas clinical trial data based on the ethical, legal and scientific principles, as well as the clinical data and technical requirements of overseas clinical trial data. The guideline further elaborates the requirements for submission such as the technical review requirements, the data of study participants and the variations in clinical trial conditions. In addition, the guideline also provides some examples to describe the implications of different variables on the clinical data.
The release of this Guideline will help manufacturers avoid or reduce repetitive clinical trials and speed up the process of medical device listing in China.