[筆記] 韓國Mobile Medical App Safety Guidance

這個審查指引中文跟英文都有好幾個寫法，這是我自己的英文翻譯：

Mobile Medical App Safety Guideline

在新竹生物醫學園區的網頁則是使用「醫療行動裝置應用程式(Medical Mobile App)審查指引」這個名稱，本文如下：

韓國MFDS已於2013/12/26發布「醫療行動裝置應用程式(Medical Mobile App)審查指引」，未來與健康照護相關的行動裝置應用程式在韓國會被歸類於醫療器材管理，並須符合韓國當地的醫療器材法規。
註: 美國FDA甫於2013/9/25發布「Mobile Medical Applications-Guidance for Industry and Food and Drug Administration Staff」此份關於醫療行動裝置應用程式的審查指引，韓國在國際法規調和與進展方面十分迅速。

韓文本文：
모바일 의료용 앱 안전관리 지침
(直譯：Mobile 醫療用 App 安全管理指南)

原始頁面連結，點選"모바일 의료용 앱 안전관리 지침.pdf [size : 695567 Byte]"

即可看到完整內容～～～

關鍵字： KFDA, MFDS, Mobile Medical App guidance, Guideline

KFDA Guidance on Mobile App for Medical Use
http://koreaniplaw.blogspot.tw/2014/02/kfda-guidance-on-mobile-app-for-medical.html

Korean government pushes for regulatory reform in mobile medical device sector
http://www.lexology.com/library/detail.aspx?g=7be1d36c-6e85-4433-94f6-30f62ab14b09

The MFDS issued the safety guidelines for mobile medical applications
http://www.lexology.com/library/detail.aspx?g=b6d64779-7bfa-4a19-94d9-7bb78787c43e


KFDA [MFDS]
Pending Changes
Review of Technical Documents by Third Parties
Present
In Feb. 2011, KFDA outsourced 100 different types of class II devices for third-party review.
Technical documents of all other class II, III and IV devices are reviewed by KFDA
Future
Additional 300 items to be outsourced by KFDA for third-party review by the end of 2011.
All class II devices to be outsources for technical documents reviews eventually