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國.家藥品監督管理局《醫療器械不良事件監測和再評價(jià)管理辦法(修正案草案)》(征求意見(jiàn)稿) 公開(kāi)征求
發(fā)布日期:2021-11-29 11:21:10瀏覽量:1411

為貫徹《醫療器械監督管理條例》(國務(wù)院令第739號),進(jìn)一步規范醫療器械不良事件監測和再評價(jià)管理工作,我們起草了《醫療器械不良事件監測和再評價(jià)管理辦法(修正案草案)》(征求意見(jiàn)稿),現向社會(huì )公開(kāi)征求意見(jiàn)。公眾可通過(guò)以下途徑和方式提出反饋意見(jiàn):

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(yè)主菜單的“立法意見(jiàn)征集”欄目提出意見(jiàn)。

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

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

意見(jiàn)反饋截止時(shí)間為2021年12月22日。

國.家藥品監督管理局

2021年11月23日

《醫療器械不良事件監測和再評價(jià)管理辦法(修正案草案)》(征求意見(jiàn)稿).docx

《醫療器械不良事件監測和再評價(jià)管理辦法(修正案草案)》起草說(shuō)明.docx

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