MFDS Updates Class II Notification Rules — Effective July 2026

What Changed

MFDS Notice 2026-31 (의료기기 제2등급 신고 절차 개선안) introduces three significant changes:

Change 1: Streamlined Notification for Low-Risk Class II

Previously: All Class II devices required full registration (허가) with technical dossier review.

Effective July 2026: Low-risk Class II devices in defined categories can use streamlined notification:

• Reduced documentation requirements
• Faster review (30–45 days vs 60–90 days)
• Lower MFDS fees (~₩1.5M vs ₩4M+)
• KGMP still required

Change 2: Class I/II Boundary Clarification

The notice clarifies devices that previously sat ambiguously between Class I and Class II:

• Specific intended use language now drives classification
• Borderline devices have clearer classification guidance
• MFDS pre-submission consultation for borderline cases recommended

Change 3: Updated Korean Medical Device Classification Code

40+ classification codes updated:

• New categories for digital health and AI devices
• Updated codes for IVD devices
• Removed redundant codes
• Clarified codes for combination devices

Affected Device Categories

Streamlined Class II notification eligibility:

Category	Example Devices
Simple monitoring devices	Manual sphygmomanometers, glucose meters (basic)
Basic surgical instruments (powered, low-risk)	Some powered handheld instruments
External electrical stimulators (low-risk)	Some TENS devices
Diagnostic ultrasound accessories	Some probes and accessories
Selected dental devices	Some restorative materials

Full list available in MFDS Notice 2026-31 Appendix.

Streamlined Notification Process

For eligible Class II devices:

Documentation Required

• Korean STED (abbreviated format, ~60–80 pages vs 150+)
• KGMP certificate
• Korean labeling
• Clinical equivalence statement (vs full clinical evaluation)
• KLH information

Submission

• Filing via KLH through MFDS electronic portal
• Reduced MFDS fees (~₩1.5M, $1,100)
• Review timeline: 30–45 days

Approval

• KMD number issued
• Subject to surveillance audit (same as full registration)
• Same post-market obligations

Comparison: Full Class II Registration vs Streamlined

Aspect	Full Registration (허가)	Streamlined Notification
Eligible devices	All Class II	Specific low-risk categories
Documentation	Full Korean STED	Abbreviated Korean STED
MFDS fees	₩4M+ ($3K+)	~₩1.5M ($1.1K)
Review timeline	60–90 days	30–45 days
KGMP required	Yes	Yes
Clinical evaluation	Full	Equivalence statement
Post-market obligations	Full	Full

Who Benefits

Manufacturers benefiting most from streamlined notification:

• Foreign manufacturers with low-risk Class II devices
• Manufacturers with existing CE Mark or FDA 510(k) for substantially equivalent devices
• Manufacturers with constrained budgets seeking faster Korean entry
• Class II portfolio holders (multiple products gain efficiency)

Who Doesn't Benefit

Streamlined notification not applicable to:

• Class III/IV devices
• Class II devices in higher-risk categories
• Novel devices without clear equivalence
• Devices with significant Korean-specific clinical considerations

Strategic Implications

For Pending Submissions (Pre-July 2026)

• Submissions filed before July 2026: full registration process
• Consider delaying submission until after July 2026 if device eligible for streamlined
• Cost-benefit analysis: filing date vs reduced cost

For New Submissions (Post-July 2026)

• Assess streamlined eligibility for each device
• Strategic mix of full registration (premium devices) and streamlined (low-risk)
• Faster market entry for streamlined-eligible portfolio

For Existing Approvals

• No retroactive impact
• Changes to existing licenses: existing change notification rules apply

What to Do — 3 Actions

Action 1: Assess Portfolio Eligibility (June 2026)

• Review portfolio against Notice 2026-31 streamlined eligibility list
• Identify devices eligible for streamlined notification
• Plan submission strategy for new products

Action 2: Pre-Submission Consultation (June–July 2026)

For borderline cases:

• MFDS pre-submission consultation
• Confirm classification
• Confirm streamlined eligibility

Action 3: Update Submission Templates (June 2026)

• Develop abbreviated Korean STED template for streamlined submissions
• Train regulatory team on streamlined process
• Adjust pricing models for clients

Cost Impact

For eligible Class II devices:

Cost Component	Full Registration	Streamlined
MFDS fees	$3K–$6K	~$1.1K
Documentation prep	$25K–$50K	$15K–$30K
Translation	$8K–$15K	$5K–$10K
Total Per Device	$36K–$71K	$21K–$41K

Approximately 40–50% cost reduction for eligible devices.

Frequently Asked Questions

Q: How do we know if our device qualifies for streamlined notification?

A: Reference Notice 2026-31 Appendix or consult MFDS pre-submission consultation. Leanabl can provide eligibility assessment.

Q: Can we use streamlined for devices we previously approved through full registration?

A: No retroactive changes. Existing licenses remain under their original approval. Future submissions for new products can use streamlined if eligible.

Q: Does streamlined notification have lower post-market burden?

A: No. Post-market obligations (vigilance, change notifications, renewals) same as full registration.

Q: Is KGMP still required for streamlined?

A: Yes. KGMP requirement unchanged for Class II regardless of submission pathway.

Q: How does Leanabl help with the new rules?

A: Leanabl's Korea Class I Express Registration service is expanding to cover streamlined Class II notification (post-July 2026). Korea Medical Device Registration handles full registration.

How Leanabl Helps

• Korea Class I Express Registration — fast-track pathway (Class I + eligible streamlined Class II)
• Korea Medical Device Registration — full registration
• Regulatory Pathway Strategy — eligibility assessment

Contact Leanabl for Class II strategy.

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Last updated: 2026-05-08.