Complete MFDS Fee Structure 2026: Registration, KGMP, and Annual Costs

MFDS Official Fees by Pathway

All fees are MFDS government fees only. Consulting, documentation, KGMP, and KLH services are separate.

Class I Notification (신고)

Fee Type	Amount (KRW)	USD Equivalent
Initial notification	₩300,000	~$220
Change notification	₩150,000	~$110
Notification renewal	₩300,000	~$220

Class II Registration (허가)

Fee Type	Amount (KRW)	USD Equivalent
Initial registration (standard)	₩4,000,000	~$3,000
Initial registration (extended review)	₩8,000,000	~$6,000
Change registration (major)	₩2,000,000	~$1,500
Change registration (minor)	₩500,000	~$370
Renewal	₩2,000,000	~$1,500

Class III–IV Registration (허가)

Fee Type	Amount (KRW)	USD Equivalent
Initial registration	₩12,000,000–₩20,000,000	~$9,000–$15,000
Change registration	₩3,000,000–₩6,000,000	~$2,200–$4,500
Renewal	₩6,000,000	~$4,500

KGMP Inspection Fees

KGMP inspection fees vary by inspection scope and site complexity.

Inspection Type	Amount (KRW)	USD Equivalent
Initial KGMP (single product line)	₩8,000,000–₩15,000,000	~$6,000–$11,000
Initial KGMP (multiple product lines)	₩15,000,000–₩30,000,000	~$11,000–$22,000
Surveillance audit (annual)	₩5,000,000	~$3,700
Renewal inspection (every 3 years)	₩8,000,000–₩12,000,000	~$6,000–$9,000

Note: For foreign manufacturer sites, add travel expenses for MFDS inspectors (~$5K–$10K).

Total Program Cost (Foreign Manufacturer)

Cost Component	Class I	Class II	Class III/IV
MFDS official fees	$220–$440	$3K–$6K	$9K–$15K
KGMP inspection (if required)	N/A	$11K–$22K	$11K–$30K
Documentation preparation (consulting)	$3K–$8K	$15K–$40K	$40K–$80K
KLH setup	$2K–$5K	$2K–$5K	$2K–$5K
Translation (Korean)	$2K–$5K	$5K–$15K	$10K–$25K
Clinical evidence preparation	N/A	$5K–$20K	$20K–$60K
Total Program Cost	$7K–$18K	$40K–$110K	$90K–$200K

Annual Maintenance Costs

After initial registration, ongoing costs:

Annual Cost	Range
KLH service fee	$8K–$25K
License renewal (amortized, every 3 years)	$1K–$5K
Change notifications (typical)	$2K–$10K
Vigilance reporting setup	$3K–$8K (initial)
KGMP surveillance audit	$3K–$7K
Annual total	$15K–$50K

Cost Breakdown Examples

Example 1: Foreign Class I IVD Manufacturer

• Device: Manual blood glucose test strip (Class I IVD)
• Total program cost: $9K
  • MFDS official fee: $220
  • Documentation: $4K
  • KLH setup: $3K
  • Translation: $1.5K
• Time to market: 6 weeks

Example 2: Foreign Class II Surgical Device Manufacturer

• Device: Powered surgical handpiece (Class II)
• Total program cost: $78K
  • MFDS official fee: $4K
  • KGMP inspection: $15K
  • Documentation: $30K
  • KLH setup: $4K
  • Translation: $10K
  • Clinical evaluation: $15K
• Time to market: 6 months

Example 3: Foreign Class III AI/ML Medical Device

• Device: AI-assisted radiology software (Class III)
• Total program cost: $165K
  • MFDS official fee: $12K
  • KGMP inspection: $20K
  • Documentation: $60K
  • KLH setup: $5K
  • Translation: $18K
  • Clinical evaluation + Korean clinical study: $50K
• Time to market: 10 months

Where Manufacturers Overspend

Common cost-inflation patterns from foreign manufacturer experience:

Inflation Source	Typical Excess
Translating full CE Annex II instead of reformatting to MFDS STED	$5K–$15K
Conducting redundant clinical study when literature evidence suffices	$20K–$80K
Using distributor-bundled KLH with high commercial margin	$10K–$30K/year
KGMP gap remediation after failed inspection (vs. pre-audit)	$20K–$50K
Pursuing Class II registration when Class I is appropriate	$40K–$100K

Where Manufacturers Underspend (Then Pay Later)

Common under-investment patterns that cost more downstream:

Under-investment	Eventual Cost
Skipping pre-submission review	1–2 deficiency notice rounds: $10K–$30K + 60–120 days
KGMP without gap analysis	Failed inspection re-audit: $20K–$40K + 4–6 months
Distributor-KLH without exit clause	License transfer at distributor change: $30K–$60K + 4–6 months
Minimal post-market vigilance setup	MFDS audit findings or recall: $50K–$500K+

How to Estimate Your Total Cost

Use this decision tree:

1. Determine class (Class I, II, III, IV) → see total program ranges above
2. Add KGMP: Required for Class II+, add $15K–$22K
3. Add clinical evidence: Add 5–60K depending on existing data
4. Add translation: Estimate 10–20% of documentation cost
5. Annual maintenance: Plan $15K–$50K/year

Frequently Asked Questions

Q: Are MFDS fees negotiable?

A: No. Official fees are statutory and not negotiable. Consulting and KLH fees vary by provider.

Q: Does Leanabl provide fixed-fee proposals?

A: Yes for most programs. Leanabl prices fixed-fee where the path is known (Class I notifications, well-defined Class II registrations). For Class III/IV or unclear scope, we provide named risks with cost ceilings.

Q: What if MFDS issues a deficiency notice — do we pay more fees?

A: No additional MFDS official fees for deficiency responses. However, consulting costs to respond typically run $5K–$15K per deficiency round.

Q: When do we pay MFDS fees — upfront or after approval?

A: Upfront, at submission. MFDS fees are non-refundable even if approval is denied.

Q: How much should we budget for unexpected costs?

A: Add 15–25% contingency to total program cost. Most overruns trace to clinical evidence gaps or KGMP inspection findings.

How Leanabl Helps

• Korea Total Access Program — fixed-fee end-to-end market entry
• Regulatory Pathway Strategy — cost optimization
• KGMP Certification — KGMP without gap remediation overruns

Contact Leanabl for a fixed-fee scoping proposal.

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Last updated: 2026-05-15.