Global Regulatory Pulse

CFDA Oversea GMP Inspections

In Asian Market, Regulatory by Dr. Jiechen Yin

Observing and learning the successful experiences in the world’s top healthcare providers, China Food and Drug Administration (CFDA) organized the first two rounds of oversea GMP inspections in 2015 and 2016, targeting industrial leading companies.

These inspections are organized and performed by the Center for Food and Drug Inspection of the CFDA. Other accountabilities include conducting GMP on-site audits and planned inspections of clinical trials, in addition to managing unannounced audits on medical devices that pertain to research and development, manufacturing and sales.

CFDA started its oversea GMP inspections in the year of 2015, focusing on the quality systems of medical devices of Class III high-risk implants. Devices such as artificial knee joint system, bone cement and tibial prosthesis were inspected.

CFDA oversea GMP inspections this year will cover a wider range of devices from more medical device manufacturers all over the world. Geographically, a total of 19 oversea medical device manufacturers located in Germany, France, United States, Ireland, Sweden and Japan will be inspected. Both active and non-active medical devices will be inspected, including, but not limited to, X-ray imaging systems, magnetic resonance imaging systems, vascular stents, artificial lenses and in vitro diagnostic reagents.

Oversea GMP inspections are clearly becoming a growing trend with CFDA. If this trend continues, these inspections will be more than likely carried out on a regular basis, with more manufactures and wider varieties of medical devices involved.

Authors:

Dr. Jiechen Yin joined NAMSA China in June 2016 as Medical Writer, responsible for composing Clinical Evaluation Reports (CERs) and other essential documents. Dr. Yin has 8 years of R&D experience in the field of medical device in academia, and worked as a Collaboration Scientist and Product Manager in Siemens Healthcare. She received her Ph.D. degree in Biomedical Engineering from University of California, Irvine.