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

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.