South Korea

A data-driven analysis of South Korea's MFDS medical device registry. Explore risk class distributions, import vs. domestic splits, and leading sponsors.

Compare medical device registration across APAC markets — China, Japan, South Korea, Australia, Singapore, India, ASEAN — including timelines, fees, reliance pathways, and strategic entry order.

When device modifications require new regulatory submissions in the US, EU, Korea, Japan, and China — FDA special 510(k), PMA supplements, EU MDR significant changes, and Asian pathways.

KIMES 2026 exhibitor analysis: 977 companies, 78% Korean, surgical devices lead at 259 exhibitors, 94% export-ready. China tops international pavilion with 81 companies.

Korea MFDS data shows 13,117 licence holders manage 273,672 registrations. Top 20 holders control 14.4%. US firms dominate Class III/IV imports at 30.4%.

See where CE marking supports device approvals across 25+ markets, including full reliance, abridged review, evidence acceptance, and remaining local steps.

Guide to South Korea's Digital Medical Products Act, covering DMPA categories, MFDS classification, approval pathways, AI/ML requirements, cybersecurity, QMS, and labeling.

Benchmark medical device regulatory consulting rates by region and consultant tier, with cost drivers and budgeting guidance for registration projects in major markets.

Guide to South Korea medical device procurement and reimbursement, covering MFDS approval, HIRA listing, NECA HTA, Immediate Market Entry, pricing, and foreign manufacturer strategy.

Guide to KGMP certification for foreign medical device manufacturers, covering MFDS requirements, document preparation, audit types, costs, timelines, and 2026 GMP updates.

Navigate South Korea's medical device regulatory system — MFDS classification, KGMP, approval pathways, clinical requirements, and practical market entry guidance.