MFDS

The complete guide to South Korea's Digital Medical Products Act — product categories (digital medical devices, digital-convergence pharmaceuticals, digital health-support devices), MFDS classification, approval pathways, AI/ML requirements, cybersecurity obligations, QMS, and labeling requirements.

How South Korea procures and reimburses medical devices through the National Health Insurance Service (NHIS) — including MFDS approval, HIRA reimbursement listing, NECA health technology assessment, the new Immediate Market Entry pathway, pricing and payment mechanisms, and strategies for foreign manufacturers entering Korea's $7.5 billion medical device market.

Everything foreign manufacturers need to know about Korea Good Manufacturing Practice (KGMP) certification in 2026 — including MFDS requirements, application process, document checklist, audit types, costs, timeline, and how to prepare for the updated 2026 GMP regulations.