Korea Announces Plans for Unique Device Identification (UDI) Requirements Starting in 2019

2022 Update on UDI Implementation in Korea

UDI has now been fully implemented with all classes of medical devices requiring a Unique Device Identifier. 

Please contact Asia Actual today if you have questions about UDI or the registration process in Korea.

Korea Medical Device UDI Requirements

The Korean Ministry of Food and Drug Safety (MFDS) published a draft amendment to the Medical Device Act that mandates a new Management System for Controlling Medical Device Information (MCMI) to record information on the overall life cycle of the medical devices from manufacturing to end-use.

When implemented, manufacturers or importers must input the following information into the MCMI prior to product release into the Korean market:

  1. UDI (Unique Device Identification) of each model
  2. Basic information of the model
  3. Information on the manufacturer and importer
  4. Miscellaneous information required by applicable MFDS notification

Implementation deadlines are assigned by risk classification starting with high-risk Class 4 devices on January 1, 2019; followed by Class 3 device on January 1, 2020; Class 2 device on January 1, 2021; and finally Class 1 devices on January 1, 2022.

Manufacturers or importers are responsible to keep MCMI information up to date for three years from the date of ceasing product sales in Korea.

Contact Asia Actual to register medical devices in Korea with consideration of UDI requirements.

Sarah Baik

“Manufacturers must now have a UDI on all of their products sold in Korea. UDI is usually a bar code or QR code with numbers associated with the UDI-Device Identifier (UDI-DI) and UDI-Production Identifier (UDI-PI).”

Sarah Baik
GM, Korea
Asia Actual

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