MFDS

[2026-01-27]Korea Launches Fast-Track System for Innovative Medical Devices, Reducing Entry to 80 Days

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The Ministry of Health and Welfare and the MFDS will implement the ‘Immediate Market Entry Medical Technology’ system from June 26, exempting innovative devices with international clinical evaluation from new technology assessment.
This reform shortens the entry period for medical devices from up to 490 days to as little as 80 days, covering 199 items including 113 digital devices.
Safety measures and controls against non-reimbursed overuse are included, aiming to boost industry innovation and accelerate adoption of advanced technologies.

[2026-01-26]Innovative Medical Devices to Enter Market in Just 80 Days

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The Ministry of Health and Welfare and the Ministry of Food and Drug Safety will implement the Immediate Market Entry Medical Technology system from January 26, 2026.
With this system, medical devices that pass international-level clinical evaluations can enter the market in as little as 80 days without separate new technology assessments.
Patient safety and non-reimbursement management will be strengthened, covering 199 items including digital medical devices.

[2026-01-18]KFDA to Release Tobacco Harmful Substance Test Results in October

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The Korea Food and Drug Administration (KFDA) will disclose the results of tobacco harmful substance tests in October.
Manufacturers and importers must submit test results by the end of this month, following the Tobacco Harmful Substance Management Act enacted in November 2023.
KFDA aims to enhance public health and promote a smoke-free environment by strengthening scientific disclosure and testing systems.

[2026-01-15]Nationwide Expansion of Meal Management Centers and Nutrition Labeling for Chicken

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The government will expand integrated meal management support centers to all 228 cities, counties, and districts to enhance hygiene and nutrition for vulnerable groups, including the elderly and disabled.
This year, nutrition labeling will be extended to chicken, and a pilot project for ‘Healthy Food Stores’ will be launched at 300 convenience stores nationwide.
The Ministry of Food and Drug Safety aims to strengthen evidence-based nutrition information to create a healthier dietary environment for all citizens.