法律新聞 - 醫療
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醫療器材標示規定(Labeling Rules under Medical Devices Act)
衛生福利部(衛福部)於 2021 年 4 月 28 日發布有關醫療器材標籤、說明書或包裝之規定。茲說明重點如下:
(一)除衛生套、衛生棉塞、乳膠病患檢查手套、滅菌類、植入類及體外診斷試劑之醫療器材外,其餘醫療器材得僅刊載製造日期,免刊載有效期間或保存期限。
(二)植入式金屬材質醫療器材符合下列條件者,得僅刊載製造日期,免刊載有效期間或保存期限:
1. 使用前滅菌。
2. 不具分解特性。
3. 非積層製造。
4. 無表面塗覆物質。
(三)單獨之軟體類醫療器材已標示軟體版本資訊者,得免刊載製造日期及有效期間,或保存期限。
(四)使用人力及重力以外能源之醫療器材,其製造日期得僅刊載年、月。

報告人:劉康身律師/陳威達律師

On 28 April 2021, the Ministry of Health and Welfare (MOHW) issued a ruling with respect to the labelling, user guide or packaging of medical device. We summarize below:
(1) Except for the medical devices, such as condom, tampon, latex exam gloves, sterilization, implantation and In Vitro Diagnostic reagent, other medical devices may only label the date of manufacture, and validity or storage period are not required to be labeled.
(2) If the implantable medical device with metal material comply with the following requirements, it may only label the date of manufacture, and validity or storage period are not required to be labeled:
(a) Sterilizing prior to use;
(b) No decomposition nature;
(c) No additive manufacturing; and
(d) No coating material on the surface.
(3) The stand-alone software medical device which has been labeled with the version information of software is not required to label the date of manufacture and validity period, or storage period.
(4) The medical devices using energy other than manpower and gravity may only label “year” and “month” for the date of manufacture.

Reported by: Kang-Shen Liu / Will Chen

惇安法令雙週刊 第 368 期

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