Define Your Exact Route to the Korean Market.
A wrong classification delays your launch by years.
South Korea’s Ministry of Food and Drug Safety (MFDS) operates on a unique regulatory framework. A Class II device in Europe or the US might be classified as a Class III or even a novel device in Korea. Going in blind—without a verified predicate device or a clear understanding of the MFDS, NECA (Health Technology Assessment), and HIRA (Reimbursement) sequence—leads to rejected applications, wasted budgets, and paralyzed launch plans.
Precise MFDS Classification
Determining the exact product code and regulatory class specific to South Korea. as needed, submitting the official classification request to MFDS.
Predicate Device Identification
Searching and analyzing locally approved equivalent devices to justify your regulatory route.
Multi-Agency Sequencing
Structuring the critical timeline between MFDS/NIDS (Safety/Efficacy clearance), NECA (New Health Technology Assessment), and HIRA (Insurance Reimbursement).
The Executive Masterplan
You receive a concise, actionable "Regulatory Pathway Report" designed for immediate C-suite review and budget approval. Includes: Confirmed regulatory class, valid predicates, required clinical data, step-by-step timeline, and transparent budget estimation.
Proven Execution Across Modalities.
Dental Innovation
Complete regulatory pathway for a major US orthodontic brand.
Vision Care
New Product Development & entry strategy for a top contact lens maker.
Digital Health
Fast-tracked software validation requirements for a diagnostic AI.
Total predictability for your decision and plan.
Eliminate hidden costs and regulatory surprises. By defining the exact scope of work upfront with an independent consultancy, your leadership team gains the clarity needed to approve budgets and forecast Korean revenue with confidence.
Speak with a Strategy Director TodayFrequently Asked Questions
Answers to common market entry questions.