TBT BSN | Notification

Notification Detail :: G/TBT/N/KOR/1216

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

Proposed partial amendments to the ”Regulation on In Vitro Diagnostic Medical Device Approval/Report/Review, etc.”;

Objective

Protection of human health or safety (TBT)

Product Covered

In Vitro Diagnostic Medical Devices

Document Notification

Link to ePing

HSCODE

ICSCODE

11.100.10 - In vitro diagnostic test systems

Keywords

Human health

Specific Regions

Description

The proposed amendments to the ”Regulation on In Vitro Diagnostic Medical Device Approval/Report/Review, etc.” are as follows:   _x000D_
A.  Allow occasional reporting of minor matters of  in vitro diagnostic medical devices and extend the quarterly reporting period._x000D_
B.  After changing  in vitro diagnostic medical devices, it was not possible to manufacture (import) the existing devices, but if the change was not due to side effects, manufacture (import) of the existing devices  is allowed for six (6) months.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/KOR/1216

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