On February 27th, 2016, CFDA published a rejection announcement for a Japanese IVD product, causing an uproar in the medical device industry. This announcement was of no ordinary rejection, but a specific rejection resulting from authenticity verification of clinical trial data. This is the first case for a medical device rejection under these circumstances, meaning the CFDA authenticity verification of clinical trial data on medical devices has officially begun.
CFDA carried out the most rigorous and extensive authenticity verification of clinical trial data on pharmaceuticals in 2015, resulting in the rejection or withdrawal of several pharmaceutical manufacturers. CFDA declared the authenticity verification of clinical trial data on medical devices is one of their main focuses for 2016.
If manufacturers discover problems with their clinical trial data and withdraw their registration application, no disadvantageous information will be published and no additional penalties will be received. However, if CFDA finds issues during their authenticity verification of clinical trial data on the medical device, the information will be published on the CFDA website, and the manufacturer cannot apply for registration for the product within one year.
The following are two important suggestions for medical device manufacturers which have conducted or started to conduct clinical trials in China:
- Do self-inspections prior to submitting a registration application, and take corrective actions as soon as any issues have been recognized.
- Choose a competent and professional organization to partner with for clinical trials.
China State Food and Drug Administration. (2016, February 27). General notice of hepatitis B virus core Japan-Europe will Guthrie Corporation associated antigen (HBcrAg) detection kit not registered (2016, No. 44). Retrieved March 3, 2016, from http://www.sfda.gov.cn/WS01/CL0087/145401.html.