Korea MFDS Supplies Medical Devices for Emergency

The Ministry of Food and Drug Safety in South Korea announced on December 21st that it has designated a total of 18 medical devices, including artificial blood vessels and vascular stents, to help treat rare and incurable diseases from last year to the present.

“Medical Devices Supply System for Rare disease that requires an emergency license(System)” is a system where a medical device that is needed for treatment or surgery of rare and incurable patients is not licensed and available in Korea, the government would grant a license and supply them directly.

A total of 1,645 products have been supplied to 42 medical institutions since 2019 under the System.

The Ministry of Food and Drug Safety stated in its press release that “We have discussed with the Ministry of Health and Welfare and the Health Insurance Review and Assessment Service to list seven of the 18 rare and urgent medical devices as targets for medical care benefits.”

“In the future, we will continue to communicate with related institutions such as related academic societies, associations, and patient organizations so that rare and incurable diseases can receive necessary medical devices at a timely time and make more efforts to guarantee treatment opportunities for rare and incurable patients through rapid and stable supply,” it said.


Categories: Clinical