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第一筆上一筆下一筆最末筆筆數:11/99
醫療器材來源流向資料建立及管理辦法(Regulation of Establishment and Management of Medical Devices' Source and Flow Data)
衛生福利部於 2021 年 4 月 20 日公告訂定「醫療器材來源流向資料建立及管理辦法」,自 2021 年 5 月 1 日施行。要點簡述如下:
(一)醫療器材許可證所有人或登錄者及醫療器材販賣業者,應建立及保存產品來源及流向資料,其範圍及方式之規定。
(二)醫事機構就其使用之醫療器材,應建立及保存產品來源資料範圍與方式,及病人資訊之規定。
(三)醫療器材來源及流向資料申報期限及申報方式之規定。
(四)產品識別資訊內容之規定。
(五)依前述第(三)點規定申報之醫療器材,其屬應刊載單一識別碼者,其申報之產品資訊,應以單一識別碼代之。
(六)醫療器材來源及流向資料保存期限之規定。

報告人:王惠玲顧問/張晏溥

On 20 April 2021, the Ministry of Health and Welfare (MOHW) announced the "Regulation of Establishment and Management of Medical Devices' Source and Flow Data" (Regulations), which became effective as of May 1, 2021. The Regulations are summarized below:
(1) To define the scope and methods for an owner or a registrant of medical device permission, and a firm selling medical devices to establish and maintain the data regarding products' source and flow;
(2) To define the scope and methods for a medical institution to establish and maintain the data regarding products' sources and patients' information with respect to the medical devices as used;
(3) To set time limits and methods for submitting a report on medical devices' source and flow;
(4) To specify the contents of product identification information;
(5) To require the product identification information to be replaced by a Unique Device Identifier (UDI) for a medical device that is required to be labelled by a Unique Device Identifier (UDI) code in accordance with the above mentioned Item (3); and
(6) To set a period of the maintenance for the data on medical devices' source and flow.

Reported by: Jolene Wang / Yenpu Chang

惇安法令雙週刊 第 367 期

第一筆上一筆下一筆最末筆筆數:11/99
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