The Ministry of Food and Drug Safety (MFDS) plans to make multiple amendments to the country's Medical Device Act during 2022 and expand its list of eligible devices for electronic indications for use.
Important amendments to the Medical Device Act
MFDS introduced three major amendments to South Korea medical device regulations next year:
· Sealing of medical devices: Devices that are inserted into the human body or that can deteriorate or degrade
once opened must be sealed. Starting from 21 January2022, such devices with open or unsealed packages cannot
be sold in the South Korean market.
· Violation fines: Starting from 21 January 2022, fines for violations of the Medical Device Act will be adjusted.
· Insurance: Adjusted requirements for certain device manufacturers to purchase insurance will take effect on 21
July 2022 to offset losses caused by the use of this device, which caused by serious injury or death of patients.
Extending qualification for electronic indications for use (IFU)
MFDS also has added up to its list of devices for which manufacturers may give IFU data through electronic form such as webpage. They have included 203 devices to the list, which suggests there are presently 2142 qualified devices for electronic IFU.
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