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第一筆上一筆下一筆最末筆筆數:10/99
醫療器材回收處理辦法(Regulations for Medical Device Recall)
衛生福利部於 2021 年 4 月 28 日發布醫療器材回收處理辦法,重點如下:
(一)回收作業分級及完成期限之規定。
(二)醫療器材許可證所有人或登錄者應建立醫療器材回收作業程序及其程序內容之規定。
(三)醫療器材許可證所有人或登錄者執行醫療器材回收作業,應限期通知直接銷售對象,並就通知內容為記錄及保存。
(四)醫療器材許可證所有人或登錄者執行醫療器材回收作業,應製作回收作業計畫書,及計畫書內容與限期陳報主管機關之規定。
(五)回收醫療器材應予識別、標示及分別存放。
(六)執行回收成果報告書應記載內容及限期陳報主管機關。
(七)地方主管機關應確認回收醫療器材最終處置方式及結果。

報告人:劉康身律師/魏心純

On 28 April 2021, the MOHW announced the Regulations for Medical Device Recall. We summarize below:
(1) To provide the classification and time limit to complete recall.
(2) To demand medical device license owners or registrants to establish the medical device recall operation protocol with the required details.
(3) To demand medical device license owners or registrants who recall the medical devices to notify the direct purchasers and keep records of such notifications.
(4) To demand medical device license owners or registrants who recall medical devices to produce recall operation proposals specifying the required particulars and to report the same to the competent authority within the required time frame.
(5) Medical device to be identified, marked and stored separately after recall.
(6) To provide the contents of the report on recall operation which shall be provided to the competent authority within time limit.
(7) Regional competent authority shall confirm the final methods to dispose of the medical device and the end result.

Reported by: Kang-Shen Liu / Hazel Wei

惇安法令雙週刊 第 368 期

第一筆上一筆下一筆最末筆筆數:10/99
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