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2014年6月1日,新修订的《医疗器械监督管理条例》颁布实施,对医疗器械召回提出新要求。国家食品药品监督管理总局组织对原《医疗器械召回管理办法(试行)》进行了修改,形成《医疗器械召回管理办法》(以下简称《办法》),2017年1月5日,《办法》经国家食品药品监督管理总局局务会议审议通过,自2017年5月1日起施行。本次修改主要涉及以下内容:一是落实医疗器械召回的责任主体。明确境内医疗器械产品注册人或者备案人、进口医疗器械的境外制造厂商在中国境内指定的代理人是实施医疗器械召回的责任主体。二是明确存在缺陷的医疗器械产品范围。
On June 1, 2014, the newly revised “Regulations on the Supervision and Management of Medical Devices” promulgated and implemented new requirements for the recall of medical devices. The State Food and Drug Administration organized an amendment to the “Measures for the Management of Medical Device Recall (Trial)” to form the “Administrative Measures for Recall of Medical Devices” (hereinafter referred to as “Measures”). On January 5, 2017, the “Measures” The State Food and Drug Administration Bureau meeting was reviewed and approved and will come into effect on May 1, 2017. This revision mainly involves the following: First, the responsibility for implementing the recall of medical devices. The agents designated by the overseas manufacturers of medical device products or the record holders and imported medical device manufacturers in China are responsible for the recall of medical devices. The second is to define the scope of defective medical device products.