ARTICLE SUMMARY:
Each month in Global Spotlight we provide market access facts from the country featured on the cover of Market Pathways' print issue. In January, it was South Korea.
Regulation
Review Agency: Ministry of Food and Drug Safety (Cheongju headquarters pictured above)
Point of Interest: South Korea’s approach to generating and regulating COVID-19 tests is a model to emulate for future emergencies, according to a 2021 report by US FDA. Instead of relying on “all-comers” strategy for emergency authorized tests, which overwhelmed FDA, “South Korea developed a coordinated, nationwide testing program that relied upon a few dozen authorized tests manufactured in high volumes through public-private partnerships,” the report observed.
What’s New: The National Assembly is considering the Digital Medical Products Act to streamline the regulatory framework for digital devices, including AI-driven software.
Reimbursement
Decision Makers:
- Health Insurance Review and Assessment Service: Reviews and recommends coverage and pricing
- National Evidence-Based Healthcare Collaborating Agency (NECA): Performs health technology assessments for innovative
- Ministry of Health and Welfare: Finalizes reimbursement decision for the National Health Insurance Service
Point of Interest: Over the past decade, South Korea has instituted a series of streamlining market access procedures for innovative medtech, including conditional approvals and simultaneous health technology assessment/coverage reviews.
More Resources
- Some of our information is drawn from the International Trade Administration’s Healthcare Technologies Resource Guide on South Korea
- Jeong-Rim Lee, from the Ministry of Food and Drug Safety, presented “Regulatory Updates on Medical Devices in the Republic of Korea” during the September 2023 International Medical Device Regulators Forum meeting in Berlin
- NECA and MOHW published an informative guide several years ago on the “New Health Technology Assessment System of South Korea”
