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/935
標題: Committee on Technical Barriers to Trade - Notification - Republic of Korea - In-vitro diagnostic medical devices
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-體外診斷醫療器材

【原文】

In-Vitro Diagnostic Medical Devices; Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, and certified reference materials (excl. compound diagnostic reagents designed to be administered to the patient, blood-grouping reagents, animal blood prepared for therapeutic, prophylactic or diagnostic uses and vaccines, toxins, cultures of micro-organisms and similar products) (HS 3822); Instruments and apparatus for physical or chemical analysis, or for measuring or checking viscosity, porosity, expansion, surface tension or the like, or for measuring or checking quantities of heat, sound or light, n.e.s (HS 902780)

產品內容說明: 【中文】

韓國食品藥品安全部提案修正"體外診斷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IVD 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 In-Vitro Diagnostic Medical Devices Good Manufacturing Practices". The main changes proposed are:

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

G/TBT/N/KOR/935 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/935 Committee on Technical Barriers to Trade - Notification - Republic of Korea - In-vitro diagnostic medical devices 2020/11/17下載文件