Jun 23, 2011
China’s State Food and Drug Administration (SFDA) will implement new medical device recall regulations on July 1.
The Provisions for Medical Device Recall (interim) include 38 articles covering the supervisory system for device recalls, classification and categories of recalls as well as legal liability issues. The provisions are intended to hew closely to international conventions regarding core issues, and incorporate procedures already put in place for China’s drug recall system. Also included in the provisions are more specialized regulations to better target issues surrounding medical devices.
Update 12/20/2011: According to Emergo Group sources in Beijing, the waiver policy was instituted by the Beijing FDA (BFDA) rather than the SFDA. Furthermore, the policy applies only to domestic medical devices in China, not imports.
China’s State Food and Drug Administration (SFDA) strengthened its efforts to protect human health and safety via regulation of medical device recalls.
Recent regulations implemented by China’s State Food and Drug Administration (SFDA) now allow una