Insights

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：

1. 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

1. 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

1. 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:

1. 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

1. Types of Medical Devices Applicable for Electronic Instructions:

• Medical devices used by medical personnel

• Medical device software sold through telecommunication channels

1. 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).