The MFDS regulation was amended to add the new requirement for medical industry to purchase medical device liability insurance policy and to report the policy details to the MFDS.
This regulation went into effect as of July 21st 2022 and is applicable to all medical devices implanted to the human body over 30 days.
The coverage must be as follows:
- For a death: minimum 150 million KRW
- For a stress disorder: minimum 150 million KRW
- For an injury: minimum 30 million KRW
- Annual aggregate: minimum 300 million KRW (recommended)
The policy should specify the product/model name and the covered region (South Korea) as well.
In case where a medical device manufactured by an overseas manufacturer was already registered with the MFDS and a policy fulfilling the requirement was purchased by the manufacturer, a copy of the insurance policy must be uploaded to the MFDS e-system by August 20th 2022.
When an imported medical device is to be registered in future, such a policy must be uploaded to the MFDS system 3 days before importation.
If the regulation is not abided by, an administrative sanction (sale suspension) is subject to be imposed.