Lower the threshold for entry into the new medical device market..."Used immediately" for three years as non-payment.

2024.11.21 PM 03:16
New medical devices approved by the Ministry of Food and Drug Safety will open the way for them to enter the market immediately without going through new medical technology evaluation.

The Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and the Office for Government Policy Coordination announced the establishment of a "medical technology that can enter the market immediately" system after discussions with related ministers.

Currently, new medical devices need up to 490 days to enter the market because they need to go through approval from the Ministry of Food and Drug Safety and evaluation of new medical technologies.

However, if the entry system is introduced immediately in the second half of next year, it will be able to be used in the medical field as a non-payment for three years if only the existing technology is confirmed after approval from the Ministry of Food and Drug Safety.

If companies want, they can check whether they have existing technology at the same time as the permit process, so they can enter the market within 80 days at the earliest.

The government said it will immediately monitor the side effects of entry devices and exit them when problems arise, and apply health insurance benefits by evaluating the necessary and costly items for patients three years ago.



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