法律新聞 - 醫療
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特定醫療器材之標籤、說明書或包裝應加註警語及注意事項(Warnings and Precautions Required on the Labels, Instructions or Packaging of Specific Medical Devices)
衛生福利部於 2021 年 4 月 6 日公告訂定特定醫療器材之標籤、說明書或包裝應加註警語及注意事項,自 2021 年 5 月 1 日生效,規定以下 12 項特定醫療器材,應於標籤、說明書或包裝加註警語及注意事項:
1 衛生棉條
2 與人體接觸,含天然橡膠製成乳膠之醫療器材
3 隱形眼鏡
4 含 Persulfate 成分之假牙清潔劑(清潔錠)
5 冷熱凝膠敷包(Hot/Cold Gel Pack)
6 可移動式牙科 X 光機
7 高 DEHP(塑化劑)暴露風險之 PVC 材質醫療器材
8 動力式熱敷墊(Powered heating pad)
9 未滅菌傳導膠
10 經陰道網膜修補術治療骨盆腔臟器脫垂之手術網片(Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair)
11 成份為 70-90% 酒精者之「一般醫療器械用消毒劑」
12 玻尿酸皮下植入劑

報告人:王惠玲顧問/張晏溥

The Ministry of Health and Welfare announced the Warnings and Precautions Required on the Labels, Instructions or Packaging of Specific Medical Devices on 6 April 2021, which will become effective from 1 May 2021. The Regulation stipulates that the following 12 categories of medical devices shall contain warnings and precautions on the labels, instructions or packaging:
(1) Tampon.
(2) Medical devices in contact with human body which contain latex made of natural rubber.
(3) Contact lens.
(4) Denture cleaner (or cleaning tablet) with persulfate.
(5) Hot/Cold Gel Pack.
(6) Portable dental X-ray machine
(7) PVC medical devices with high DEHP (a plasticizer) exposure risk.
(8) Powered heating pad.
(9) Non-sterile conductive gel.
(10) Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair.
(11) Disinfectant for general medical equipment with 70-90% ethanol.
(12) Hyaluronic acid subcutaneous implant.

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:16/99
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