A draft amendment to the Korea Medical Device Act was announced on November 30th that includes operating “A Management System for Controlling Medical Device Information (herein under MCMI)” that covers information on overall life cycle of the medical devices from manufacturing to end-use.
The draft amendment mandates for medical device manufacturers and importers to attach a product label onto the product with stating UDI (Unique Device Identification) and to keep MCMI to the latest.
When this draft is enacted and applied to real life, manufacturers and importers must input the information listed below to MCMI before product release to the customers.
- UDI of each model
- Basic information of the model
- Information on the manufacturer and importer
- Miscellaneous information required by applicable MFDS notification
Changes occurred in the information must be reported within 10 days.
In case where a new UDI is allocated, that information must be reported as well.
Manufacturers and importers must update MCMI information to the latest and archive for 3 (three) years from the date of ceasing product sale.
Application schedules are as follows:
- Class 4 medical device : July 1st 2019
- Class 3 medical device : July 1st 2020
- Class 2 medical device : July 1st 2021
- Class 1 medical device : July 1st 2022
If a manufacturer or importer does not abide by this rule, an applicable administrative sanction will be followed.