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國.家藥品監(jiān)督管理局《醫(yī)療器械不良事件監(jiān)測和再評價管理辦法（修正案草案）》（征求意見稿）公開征求

發(fā)布日期：2021-11-29 11:21:10瀏覽量：1742

為貫徹《醫(yī)療器械監(jiān)督管理條例》（國務(wù)院令第739號），進(jìn)一步規(guī)范醫(yī)療器械不良事件監(jiān)測和再評價管理工作，我們起草了《醫(yī)療器械不良事件監(jiān)測和再評價管理辦法（修正案草案）》（征求意見稿），現(xiàn)向社會公開征求意見。公眾可通過以下途徑和方式提出反饋意見：

1.登錄中華人民共和國司法部中國政府法制信息網(wǎng)（http://www.moj.gov.cn、http://www.chinalaw.gov.cn）,進(jìn)入首頁主菜單的“立法意見征集”欄目提出意見。

2.電子郵箱qxjgsjcc@163.com。發(fā)送郵件時，請在郵件主題處注明“醫(yī)療器械不良事件監(jiān)測和再評價管理辦法（修正案草案）”。

3.通信地址：國.家藥品監(jiān)督管理局醫(yī)療器械監(jiān)督管理司（北京市西城區(qū)展覽路北露園1號），郵政編碼100037，并請在信封上注明“醫(yī)療器械不良事件監(jiān)測和再評價管理辦法（修正案草案）”字樣。

意見反饋截止時間為2021年12月22日。

國.家藥品監(jiān)督管理局

2021年11月23日

《醫(yī)療器械不良事件監(jiān)測和再評價管理辦法（修正案草案）》（征求意見稿）.docx

《醫(yī)療器械不良事件監(jiān)測和再評價管理辦法（修正案草案）》起草說明.docx

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