South Korea - Amendment of “Placement and Management of Unique Device Identifiers on Medical Devices”

Business description

​South Korea Ministry of Food and Drug Safety is amending the “Placement and Management of Unique Device Identifiers on Medical Devices” as stated below:

The revision of the Notifications intended that license holders for manufacturing or importing medical devices shall place UDIs in human readable formats when they apply UDIs to medical devices using data matrix barcode on the package label or device itself.

Proposed date of adoption: To be determined
Proposed date of entry into force: To be determined

Countries:
South Korea
Technical aspects:
Labeling and Packaging
Business fields:
P.05 Medical
Regions:
Asia

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South Korea - Amendment of “Placement and Management of Unique Device Identifiers on Medical Devices”