Changing Medical Device Recall Procedures in China

On June 16, 2011, the Chinese State Food and Drug Administration (SFDA) announced that the new interim “Provisions for Medical Device Recall” would go into effect on July 1, 2011. These interim provisions aim to gradually set up and improve the medical device recall system.

The Provisions for Medical Device Recall (interim) are comprised of 38 articles in six chapters and provide specific regulations for administration of medical device recalls. The Provisions detail everything from the aspects of the supervision system for medical device recalls to the classification & categories of recall and the legal liabilities. The characteristics of the interim recall Provisions include (translated to English from Chinese): “1) gearing to international conventions in core issues; 2) borrowing the drug recall system to establish the medical device recall system in the aspects of the content framework, the supervision system, the classification & categories of recall and relevant legal liabilities; and 3) defining special regulations in consideration of the characteristics of medical device supervision”.