The Notice 2026-63 exemption
Notice 2026-63 (effective Aug 31, 2026): earn a post-market study exemption for new and orphan devices with overseas evidence.
Free field guide · PDF
South Korea MFDS: Clinical Evidence2026 Field Guide
The Notice 2026-63 exemption, the immediate-entry pathway, and the investigation rules — with the MFDS practice you need.
- Notice live
- Aug 2026
- Categories
- 199
- Early entry
- 3 yrs
Sourced from verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — verified 2026 publications.
The immediate-entry pathway
199 eligible categories (113 digital + 83 IVD): enhanced clinical evaluation data buys up to 3 years of non-reimbursed market entry.
The investigation rules
Annual status reports, the 20-day completion report, 3-year data retention, and the pseudonymized-data rule.
Sources & scope
- youtube.com (Pure Global), MFDS Notice 2026-63 post-market study exemption (2026).
- shinkim.com, MoHW/MFDS Immediate Market Entry Pathway (Jan 25, 2026).
- mfds.go.kr, Enforcement Rule of the Medical Devices Act.
This guide is market-access intelligence, not regulatory or legal advice. MFDS clinical requirements, notice criteria, and nHTA rules change — professional review is required before business use.
Market Access Strategy Session
Korea on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your MFDS route — Notice 2026-63 exemption, immediate-entry eligibility, and evidence strategy.
Professional review is required before business use.
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