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义齿是医疗机构里比较常见的医疗器械,患者普遍信任医疗机构,很少关注义齿是否有注册证,而有些医疗机构却将索证制度流于形式。一起企业伪造《医疗器械注册证》、医疗机构误用无证器械案件,敲响了加强医疗器械管理的警钟,对食品药品稽查工作也具有借鉴意义。伪造的《医疗器械注册证》北京市西城区食品药品监督管理局执法人员在监督检查时,发现某医疗机构使用的医疗器械“固定义齿”、“活动义齿”是从A医疗器械生产企业购进的。该医疗机构提供这两种医疗器械的《医
Denture is a relatively common medical device in medical institutions. Patients generally trust medical institutions, and there is little concern about whether dentures have a registration certificate. However, some medical institutions have formalized the certification system. A company forged “medical device registration certificate”, medical institutions misuse of undocumented device cases, sounded the alarm to strengthen the management of medical devices, food and drug inspection work also has reference. Forged “Medical Device Registration Card” Xicheng District, Beijing Food and Drug Administration law enforcement officers in the supervision and inspection, found that a medical device used in medical equipment “fixed denture ”, “Denture ” is from the A medical device Production companies purchased. The medical facility provides medical treatment for both types of medical devices