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国外医疗器械产品进入中国市场,必须通过国家医药管理局办理市场准入注册。未获得注册证的产品,不得以任何方式在中国销售。为依法加强医疗器械的行政监督管理工作,特在《中国医疗器械杂志》上专栏公布已获市场准入注册的国外医疗器械产品清单,供各医院和医疗器械购销单位
Foreign medical device products entering the Chinese market must go through market access registration through the State Drug Administration. Products that have not obtained a registration certificate must not be sold in China in any way. In order to strengthen the administrative supervision and management of medical devices in accordance with the law, a list of foreign medical device products registered for market access has been published in the column of “China Medical Device Magazine” for use by hospitals and medical equipment purchase and sales units.