法律新聞 - 醫療
  • 社群分享
第一筆上一筆下一筆最末筆筆數:12/99
醫療器材管理法施行細則(Enforcement Rules of Medical Devices Act)
衛生福利部於 2021 年 4 月 26 日公告訂定「醫療器材管理法施行細則」,自 2021 年 5 月 1 日施行。要點簡述如下:
(一)非屬醫療器材廣告情形及衛教宣導要件規定。
(二)醫療器材管理法中所稱「混入或附著影響品質之異物」、「製造、包裝、貼標、最終驗放」及「維修」之定義。
(三)醫療器材商登記相關事項規定。
(四)醫療器材管理法規定之應聘僱醫療器材技術人員之販賣業者範圍。
(五)中央主管機關對醫療器材商辦理查驗登記或登錄時所檢附之相關資料,得公開之範圍及方式規定。
(六)醫療器材管理法「最小販售包裝」定義,以及醫療器材標籤、說明書或包裝所為之刊載之方式及內容規定。
(七)「必要醫療器材」之醫療器材商通報內容規定、醫療器材商主動通報並採取矯正預防措施之方式、內容規定。
(八)醫療器材商申請刊播醫療器材廣告應繳交文件、廣告應包含事項、不予核准內容及核准有效期間之展延等規定。
(九)醫療器材違規案件檢舉程序、獎勵要件方式及對檢舉人安全保護之規定。

報告人:王惠玲顧問/張晏溥

On 26 April 2021, the MOHW announced the "Enforcement Rules of Medical Devices Act" (Rules), which became effective as of May 1, 2021. The Rules are summarized below:
(1) To provide the conditions where it is not deemed as an advertisement for a medical device, and the requirements for a health education advocacy;
(2) To define the terms "Foreign objects that affect product quality are mixed or packed", "manufacturing, packaging, labeling, or final inspection and release", and "repair" mentioned in the Medical Devices Act;
(3) To provide the provisions and requirements for registration of a medical device firm;
(4) To define the scope of vendors who shall employ medical device technicians as stipulated in the Medical Devices Act;
(5) To specify, for the competent authority, the scope and method of the disclosure of relevant information as submitted by medical device firms for its registration or its application for a medical device permission;
(6) To define "the smallest packaging unit for sale" mentioned in the Medical Devices Act, and to provide the methods and contents of the labels, instructions or packaging of medical devices;
(7) Regarding "Essential Medical Devices", to provide the content for submission of a general report by a medical device firm, and the method and contents of a report to be initiatively submitted, and the correction and prevention measures to be taken by a medical device firm;
(8) To specify the documents to be submitted by a medical device firm for applying for a medical device advertisement, the contents to be required in the advertisement, the contents which are not allowed to be included in the advertisement, and the extension of the period of the approval.
(9) To provide the procedures for reporting violations with respect to medical devices, rewards and protection measures for whistleblowers.

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:12/99
返回功能列