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Notification Detail :: G/TBT/N/KOR/1149
Main Data
Notification No.
Notification Type
Notifying Member
Date of Notification
Final Date for Comments
Days to Final Date
Title
Amendments to the Standards of in vitro diagnostic Medical Device Good Manufacturing Practices
Objective
Protection of human health or safety (TBT)
Product Covered
in vitro diagnostic medical device
Document Notification
Link to ePing
HSCODE
ICSCODE
Keywords
Specific Regions
Additional Data
Description
The proposed amendment to the Standards of in vitro diagnostic Medical Device Good Manufacturing Practices is as follows:_x000D_ 1) Complete transfer of KGMP audit authority to Korean private conformity assessment bodies for export-only in vitro diagnostic medical devices_x000D_ 2) Modification of required dossier for documentation review _x000D_ 3) Clarification of the KGMP audit procedure_x000D_ 4) Exemption of location change audit for in vitro diagnostic software manufacturers _x000D_ 5) Improvement of required dossier for in vitro diagnostic software manufacturers
Notified Document
1:
File here
Link to Notification
EN:
File here
FR:
File here
ES:
File here
Status Active
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Inactive
Comment
No
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