Insights
Regulation Update | Announcement on Electronic Instructions Replacing Traditional Chinese Instructions for Medical Devices
電子化說明書取代中文說明書之醫療器材品項公告
📌 公告日期：2023年3月29日
📌 根據法條：醫療器材管理法第33條第一項第十款及第二項
📌 公告內容：
電子化說明書定義：
內建於醫療器材（例如：Help系統）
由醫療器材商或製造業者提供的可攜式電子儲存裝置（如：光碟、隨身碟）
透過醫療器材商或製造業者的網站取得
適用電子化說明書的醫療器材品項：
由醫事人員使用的醫療器材
通訊交易通路銷售的醫療器材軟體
電子化說明書取代紙本說明書的醫療器材的標籤或包裝應加註事項：
「本產品提供電子化說明書，如需紙本說明書，請與醫療器材商聯繫」
醫療器材商的聯繫資訊（如：電話、電郵）
若透過網路取得電子化說明書，則應刊登其連結路徑（如：網址、QR code）
[Regulation Update]
Announcement on Electronic Instructions Replacing Traditional Chinese Instructions for Medical Devices
📌 Announcement Date: March 29, 2023
📌 Based on: Medical Device Management Law, Article 33, Paragraph 1, Subparagraph 10 and Paragraph 2
📌 Content of the Announcement:
Definition of Electronic Instructions:
Built into the medical device (e.g., Help system)
Provided by medical device dealers or manufacturers in portable electronic storage devices (such as CDs, flash drives)
Obtained through the website of medical device dealers or manufacturers
Types of Medical Devices Applicable for Electronic Instructions:
Medical devices used by medical personnel
Medical device software sold through telecommunication channels
Labeling or Packaging Requirements for Medical Devices Using Electronic Instructions Instead of Paper Instructions:
A note stating, "This product comes with electronic instructions. If you need a paper version, please contact the medical device dealer."
Contact information of the medical device dealer (e.g., phone, email)
If electronic instructions are obtained via the internet, the link path should be provided (e.g., URL, QR code).