法律新聞 - 醫療
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第一筆上一筆下一筆最末筆筆數:13/99
醫療器材分類分級管理辦法(Regulations for Governing Classification of Medical Device)
衛生福利部於 2021 年 4 月 26 日發布醫療器材分類分級管理辦法(本辦法)之規定,重點如下:
(一)醫療器材應就其功能、用途、使用方法及工作原理,視其應用科別予以分類。
(二)醫療器材由低風險至高風險分為第一等級至第三等級。
(三)規定醫療器材分類分級之品項,以及相關特殊情形之分級判定原則。
(四)針對未列入本辦法附表之醫療器材分類分級品項,規定該等醫療器材之分級。

報告人:劉康身律師/陳威達律師

On 26 April 2021, the MOHW announced the Regulations for Governing Classification of Medical Device (Regulations). We summarize below.
(1) The medical device shall be classified according to its application category in terms of its function, purpose, use method and working principle.
(2) The medical device is classified into three levels from low-risk to high-risk.
(3) To provide items for classification of the medical device, and classification and determination principles applicable in unique scenarios.
(4) For the medical device not included in the items for classification of the medical device in the table attached to the Regulation, the Regulation sets out the classification for such device.

Reported by: Kang-Shen Liu / Will Chen

惇安法令雙週刊 第 367 期

第一筆上一筆下一筆最末筆筆數:13/99
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