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央广网讯浙江温州检验检疫局瑞安办对一批进口无证医疗器械产品实施了监督销毁处理,该批进口医疗器械产品是一次性注射器和注射针头,数量为4000个和2000个,来自伊朗,主要用于包装设备试机使用。根据我国《医疗器械监督管理条例》的规定,该批产品属于注册管理的第三类医疗器械产品,进口时应提供国外生产商在我国注册的《医疗器械注册证》。温州检验检疫局瑞安办检验监管人员实施现场检验时,企业未能提供该进口医疗器械许
Central News Agency, Wenzhou, Zhejiang Inspection and Quarantine Rui An Office of a number of imported undocumented medical device products to implement the supervision and destruction of the batch of imported medical device products are disposable syringes and needles, the number of 4000 and 2000 from Iran , Mainly used for packaging equipment test machine. According to China’s “Regulations on the Supervision and Administration of Medical Devices,” the batch of products belong to the third category of medical device products under registration and should be provided with the “Medical Device Registration Card” registered by foreign manufacturers in China. Wenzhou Inspection and Quarantine Ruian Office of the inspection and supervision staff to implement on-site inspection, the company failed to provide the imported medical equipment Xu