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:
- UDI (Unique Device Identification) of each model
- Basic information of the model
- Information on the manufacturer and importer
- 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.