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WTO notification · TBT

South KoreaProposed measure, open for comments

Laboratory medicine – South Korea

Official title

Proposed partial amendments to the Regulation on the Permission, Notification, Review, Etc. of In Vitro Diagnostic Medical Devices

South Korea notified this proposed TBT measure to the WTO on 2 November 2026. Comments are open until 1 January 2027.

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Source: WTO ePing (opens in a new tab). Summaries by Expodite, which is independent of the WTO.

Published here:

At a glance

Products

In Vitro Diagnostic Medical Devices

Notifying member
South Korea(Korea, Republic of)
Status
Proposed measure, open for comments
Objectives
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/KOR/1386
ICS classification
  • 11.100.10 In vitro diagnostic test systems
Keywords
Human health

Key dates

Distributed by the WTO
Comment deadline
Open until 1 January 2027
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

Comments on a notification go from government to government. If this measure affects your exports, send your comments to your country's WTO TBT enquiry point before 1 January 2027, quoting the document symbol G/TBT/N/KOR/1386 and how the measure affects your products. Your enquiry point forwards them to South Korea.

Find your country's enquiry point on WTO ePing (opens in a new tab)

What the notification says

The proposed amendments to the Regulation on the Permission, Notification, Review, Etc. of In Vitro Diagnostic Medical Devices are as follows: A. Exemption from raw material declaration requirements in manufacturing (import) notifications for in vitro diagnostic equipment B. Relaxation of requirements for clinical performance study data for IVD approval C. Elimination of notarization requirements for translations of documents in foreign languages other than English D. Expansion of the scope of exemption from sales business notification for in vitro diagnostic medical devices in response to public health crisis E. Expedited review for re-applications of IVD approval

Sources

Expodite writes its summary from the official record. The notification and the documents it notifies are on the WTO's own websites.

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