MFDS
5 articles
Why FDA or CE Clearances Fail to Register Aesthetic Devices in China, Korea, and Brazil
A deep regulatory analysis of aesthetic device classification and registration pathway divergence across the US, EU, China, South Korea, and Brazil, mapping sequencing strategies and all-in costs.
South Korea MFDS Registry: Risk Class, Imports, and Sponsor Concentration
A data-driven analysis of South Korea's MFDS medical device registry. Explore risk class distributions, import vs. domestic splits, and leading sponsors.
South Korea Digital Medical Products Act (DMPA): Complete Compliance Guide (2026)
Guide to South Korea's Digital Medical Products Act, covering DMPA categories, MFDS classification, approval pathways, AI/ML requirements, cybersecurity, QMS, and labeling.
South Korea Medical Device Procurement Guide 2026: NHIS, MFDS & HTA
Guide to South Korea medical device procurement and reimbursement, covering MFDS approval, HIRA listing, NECA HTA, Immediate Market Entry, pricing, and foreign manufacturer strategy.
KGMP Certification for Foreign Manufacturers: 2026 Requirements and Process
Guide to KGMP certification for foreign medical device manufacturers, covering MFDS requirements, document preparation, audit types, costs, timelines, and 2026 GMP updates.