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WTO notification · TBT

South KoreaProposed measure, not in force yet

Medical equipment, Laboratory medicine – South Korea

Official title

Proposed enactment of the 'Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices'

South Korea notified this proposed TBT measure to the WTO on 18 June 2026. The comment period closed on 17 August 2026.

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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, not in force yet
Objectives
  • Cost saving and productivity enhancement
  • Other
Area
TBT: Technical product rulesTechnical barriers to trade
Notification type
Regular notification
Document symbol
G/TBT/N/KOR/1354
ICS classification
  • 11.040 Medical equipment
  • 11.100.10 In vitro diagnostic test systems

Key dates

Distributed by the WTO
Comment deadline
Closed on 17 August 2026
Proposed adoption
To be determined
Proposed entry into force
To be determined

How to comment

The comment period closed on 17 August 2026. You can still raise concerns about the measure with your country's WTO TBT enquiry point, quoting the document symbol G/TBT/N/KOR/1354; it can take them up with South Korea.

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

What the notification says

The Ministry of Food and Drug Safety of the Republic of Korea intends to enact the 'Regulation on Standards and Methods for Performance Evaluation of In Vitro Diagnostic Medical Devices' to provide detailed matters necessary for the implementation of the performance evaluation system, as delegated under Article 17-3 of the 'In Vitro Diagnostic Medical Devices Act' and Article 38-2 of the 'Enforcement Rule of the In Vitro Diagnostic Medical Devices Act' to include the following: A. Provide definitions for terms used in this Regulation for the performance evaluation of in vitro diagnostic medical devices. B. Establish standards and methods for performance evaluation by applying the standards and specifications prescribed under Article 19 of the Medical Devices Act, Korean Industrial Standards (KS), international standards such as ISO/IEC, and the test specifications established at the time of the permit or certification of the in vitro diagnostic medical device. C. Specify evaluation items to which the standards and methods for performance evaluation shall be applied.

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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