韓國技術性法規通知文件(TBT通知文件)

發出會員國: 韓國KO
文件編號: G/TBT/N/KOR/934
標題: Committee on Technical Barriers to Trade - Notification - Republic of Korea - Medical device
文件通知日期: 2020/11/17
評論截止日期: 2021/01/15
產品內容: 【中文】

韓國   通知-醫療器材

【原文】

Medical Device

產品內容說明: 【中文】

韓國食品藥品安全部提案修正"醫療器材優良製造作業標準"。主要修訂如下:

對於僅需進行文件審查的GMP審核,有2個新增文件需要提交。

【原文】

Ministry of Food and Drug Safety of Republic of Korea is proposing to amend the "Standards of Medical Device Good Manufacturing Practices".

The main changes proposed are:

For GMP audits that are subject to documentation review only, there are two additional documents that are required to be submitted.

G/TBT/N/KOR/934 的所有原始文件:
序號文件編號文件標題通知日期下載文件(另開視窗)
1 G/TBT/N/KOR/934 Committee on Technical Barriers to Trade - Notification - Republic of Korea - Medical device 2020/11/17下載文件