Global Regulatory Pulse

CFDA Authenticity Verification of Clinical Trial Data for Medical Device Kick Off

In Asian Market, Clinical, Consulting, Regulatory by Minna Liu

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.

Resources

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.

Authors:

Minna Liu is a Medical Research Manager at NAMSA. She has more than 15 years of experiences within the China medical device industry, and has successfully completed hundreds of imported and local medical device registrations. In addition to her extensive regulatory expertise, Ms. Liu is a certified delegate for the ISO organization - SAC/TC110/SAC, and is an expert on medical device standards. She is also an experienced Quality Assurance expert, with particular expertise in ISO 13485. Prior to her RA/QA carrer, Ms. Liu used her engineering background for research and development of medical devices, resulting in 10 Chinese patents and 8 published journal articles. Ms. Liu received her Master Degree in Material Science and Engineering from Beijing University of Aeronautics and Astronautics.