Medical device companies blacklisted in China

The State Food and Drug Administration (SFDA) of China has blacklisted 13 companies manufacturing unapproved medical devices. SFDA ran a spot check of 17 provinces, including Beijing, Shanghai, Guangdong, and others.

The unapproved medical devices included single-use transfusion machines, metal bone and joint implants, and endoscopic devices. For five companies, 80 percent of photonic cosmetic machines were unqualified, while over 40 percent of high frequency electric knives in general were unapproved. Over 10 percent of the medical devices checked were unqualified.

The companies will be subject to fines or complete shut down if they do not change their manufacturing methods and improve their quality control.

Starting in September 2007, China has launched a six-month project to inspect medical device licenses and make sure that all information submitted during the registration process is accurate. The SFDA will blacklist and publicly expose any companies supplying false information.

SFDA is also planning to improve its recall system for medical devices. SFDA has already implemented a recall system for drugs.