South Korea has emerged as a strategic market for global medical device manufacturers. Governed by the Ministry of Food and Drug Safety (MFDS), the country has a structured regulatory framework that requires manufacturers to navigate a range of compliance and registration procedures. Understanding the official MFDS fees—including those related to clinical trials, KGMP audits, and device approvals—is critical for effective budgeting and regulatory planning in 2025. 

This guide outlines the latest medical device registration fees in South Korea, based exclusively on MFDS regulations and notifications, to help manufacturers, importers, and authorized representatives make informed decisions. 

South Korean Medical Device Approval Fees

1. Fee Structure Source 

The Regulation on Fees for Pharmaceutical Approval, etc. (MFDS Notification No. 202246, effective June 27, 2022) remains the authoritative source and applies to medical device processes in 2025. 

2. Key Medical Device Fees 

A. Clinical Trial 

• Review fee for clinical trial data: ₩1,488,000 

• Technical-document review fee: ₩624,000 

• Total combined: ₩2,112,000  

B. KGMP Certification Audit 

• KGMP certification carries variable costs, based on audit scope. Third-party auditors typically charge USD 4,000–6,000 for on-site audits; renewals or document audits fall around USD 1,000–1,500. 

3. Fees for “Newly Developed Medical Devices” 

• A special fee framework applies to “newly developed” devices. 

• Integrated review fee raised from ≈₩1.49M to ≈₩9.84M to account for bundled technical and clinical data inspections. 

• Preliminary-review fee may be up to 50 % discounted for eligible applicants. 

4. Refundable/Discountable Fees 

• Up to 80 % refund available for withdrawn or invalid early reviews. 

• Newly developed devices qualifying under the scheme see preliminary review fees offset against final application fees and may receive up to a 50 % discount on the scheduled fee. 

Summary of 2025 Medical Device Fees 

Practical Guidance 

• Clinical trial filings will cost ~₩2.1 M for combined reviews. 

• KGMP audits are contractor driven and fall in USD — expect ~$4–6K first time, $1–1.5K for renewals. 

• For innovative “newly developed” devices, budget ~₩9.8 M, but pursue preliminary review discounts or fee offsets. 

• If you withdraw early or qualify for discount schemes, you may reclaim up to 80 %, saving significant cost. 

How OMC Medical Can Help 

South Korea’s MFDS registration system involves detailed procedures, language-specific documentation, and strict timelines. OMC Medical supports medical device manufacturers by providing: 

• Regulatory strategy and classification guidance 

• MFDS product registration and technical documentation support 

• Clinical trial and KGMP coordination with authorized auditors 

• Local representation in Korea through our Seoul office 

• Ongoing compliance support and post-market updates 

Whether you’re registering a Class II device or submitting a clinical trial dossier for a Class IV product, our experienced team ensures accurate filings and minimized delays—so you can focus on getting your product to market. 

Conclusion

The medical device registration process in South Korea is fee-based and strictly regulated. In 2025, manufacturers should plan for the following: 

• Base clinical trial + technical review fee: ₩2.1 million 

• KGMP audit costs: USD 4,000+ 

• Innovative product evaluations: ₩9.8 million (with potential discounts) 

To avoid delays or unnecessary costs, always consult the latest MFDS regulations and coordinate with your Korean Authorized Representative or local agent. 

All fees mentioned are based on the most recent MFDS publications available as of 2025. However, these are subject to revision by MFDS at any time.