On 26 January 2026, the Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) launched the new fast‑track market‑access system for innovative Medical Devices: “Market Immediate Entry Medical Technology.” 

The reform, preceded by a pilot phase completed in 2025, entered into force on 26 January following amendments to the “Regulation on the Evaluation of New Medical Technologies” and the “Rules on the Authorization, Notification and Review of Medical Devices”.

The pathway allows innovative Medical Devices that have passed an internationally‑level clinical evaluation by MFDS to enter the market and be used by healthcare institutions immediately after approval, without the need for a separate New Medical Technology (NMT) assessment. In particular, the product gains direct access to clinical use right after MFDS authorization.

Reduced approval timelines

Thanks to this system, the time to enter the South Korean healthcare system is drastically shortened, dropping from a maximum of 490 days to 80–140 days. This accelerated route is reserved for devices that meet specific innovation criteria and have already undergone reinforced clinical evaluation during the MFDS authorization phase.

Scope and categories

The regulatory framework applies to 199 device categories, with a particular focus on advanced technologies:

  • 113 digital devices, including Software as a Medical Device (SaMD) based on Artificial Intelligence.
  • 83 in‑vitro diagnostic reagents;
  • robotic devices, such as automated surgical systems, assistive and orthopedic robots, and powered exoskeletons.

Regulatory references and updates

The reform has been implemented through coordinated amendments to two sets of rules:

  • Amendments to the Rules on the Evaluation of New Medical Technologies (NMT), under MOHW, which define as “immediate‑entry medical technologies” those devices that have passed reinforced clinical evaluation during MFDS authorization as innovative medical technologies.
  • Amendments to the Rules on the Authorization, Notification and Review of Medical Devices, which set out the criteria for clinical evaluation, requiring complete data including institutional trials, scientific literature and real‑world data (Real‑World Data).

Asia’s push toward innovation

With the new “Market Immediate Entry Medical Technology” system, South Korea aims to accelerate patient access to innovative technologies.

The introduction of this fast‑track pathway reflects a broader trend of Asian countries investing decisively in MedTech. Alongside Korean reforms, China is also implementing strong support policies for advanced devices, with targeted incentives for integrating artificial intelligence and digitalization into diagnostic processes.

This combination of new regulatory frameworks and technological support is positioning Asian countries as a preferred launch market for next‑generation medical technologies.

>>>Complife supports international manufacturers in seizing new opportunities for access to the South Korean market, through strategic‑regulatory consulting and international registration services.

SOURCE: https://www.mohw.go.kr/board.es?mid=a10503010200&bid=0027&act=view&list_no=1488836&tag=&nPage=1