In order to gradually set up and improve the medical device recall system compliant with China’s actual supervision situation, the Provisions for Medical Device Recall (interim) was promulgated recently and shall go into effect as of July 1, 2011.

　　The Provisions, comprising of 38 articles in six chapters, provides specific regulations to the administration of medical device recall from the aspects of the supervision system for medical device recall, the classification and categories of recall and the legal liabilities. The characteristics of the Provisions include: 1) gearing to international conventions in core issues; 2) borrowing the drug recall system to establish the medical device recall system from the aspects of the content framework, the supervision system, the classification and categories of recall and relevant legal liabilities; and 3) defining special regulations in consideration of the characteristics of medial device supervision.