法律新聞 - 醫療
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醫療器材標籤應刊載單一識別碼規定(Unique Device Identifier Labeling Requirement on Labels of Medical Devices)
衛生福利部於 2021 年 4 月 6 日公告訂定醫療器材標籤應刊載單一識別碼規定,自 2021 年 5 月 1 日生效。要點簡述如下:
(一)第二等級及第三等級醫療器材之單一包裝或器材本體上,應標示單一識別碼(Unique Device Identifier, UDI);如單一包裝或器材體積過小,應標示於最小販售包裝上。
(二)前揭醫材符合下列條件之一者,免予標示 UDI:
1 客製化醫療器材。
2 外銷專用醫療器材。
3 醫療器材組合包及體外診斷醫療器材內,僅供單次使用,且非單獨使用及販售之非植入式醫療器材組件。
(三)醫療器材許可證所有人或登錄者,應將單一識別碼之產品對應資訊,登載至本部建置之醫療器材單一識別系統資訊管理平臺(UDI Database, UDID)
(四)適用期程:
1 2021 年 6 月 1 日起製造之國產及輸入第三等級植入式醫療器材。
2 2022 年 6 月 1 日起製造之國產及輸入第三等級非植入式醫療器材。
3 2023 年 6 月 1 日起製造之國產及輸入第二等級醫療器材。

報告人:王惠玲顧問/張晏溥

The Ministry of Health and Welfare (MOHW) announced the Regulation of the Unique Device Identifier Labeling Requirement on Labels of Medical Devices on 6 April 2021, which will become effective as of 1 May 2021. The Regulation is summarized below:
(1) The single package or device body of the class II or class III medical devices shall be labeled with a Unique Device Identifier (UDI); in the case where the single package or the device is too small, it shall be labeled on the smallest retail package.
(2) The aforementioned medical devices that meet one of the following conditions are exempt from labeling UDI:
(a) Customized medical devices;
(b) The medical devices dedicated to exporting; and
(c) The medical device components in combination package of medical devices and in vitro diagnostic medical devices, wherein the medical device components are non-implantable components which are for single use only, and not for stand-alone use and sale.
(3) The owner or registrant of the medical device license shall upload the product corresponding information of the UDI to the Unique Device Identifier Database (UDI Database, UDID) of Medical Device established by MOHW.
(4) Applicable schedule:
(a) Domestic and imported class III implantable medical devices manufactured from 1 June 2021.
(b) Domestic and imported class III non-implantable medical devices manufactured from 1 June 2022.
(c) Domestic and imported class II medical devices manufactured from 1 June 2023.

Reported by: Jolene Wang / Yenpu Chang

惇安法令雙週刊 第 366 期

第一筆上一筆下一筆最末筆筆數:15/99
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