MFDS medical device approvals February 2026

Overview

In February 2026, Korea’s Ministry of Food and Drug Safety (MFDS) approved 6 medical device clinical trial plans. The month’s portfolio is notable for combining a high share of exploratory studies with multiple evidence-strengthening design elements—including randomization, blinding (participant and/or assessor), sham controls, multicenter execution, and even a non-inferiority confirmatory framework.

Approved studies broadly fall into the following categories:

• Neuromuscular electrical stimulation (NMES) for functional improvement in sarcopenia
• IVUS imaging catheter assessment vs. pathology for tumor invasion depth in upper tract urothelial carcinoma (UTUC)
• CGM accuracy validation in adults with diabetes who are on (or initiating) maintenance hemodialysis
• Electrosurgical device for temporary improvement of mild–moderate bilateral cheek wrinkles
• Anti-adhesion barrier coating (Guardix SG) after lobectomy in lung cancer patients
• Tissue repair biomaterial device comparison for crow’s feet wrinkles, using an active-controlled, non-inferiority confirmatory design

February 2026 Approval Highlights (Key Summary)

• Total approvals: 6
• Device diversity: all 6 approvals represent different device categories (no single platform dominance)
• Representative indications / areas:
  • Rehabilitation / aging-related (sarcopenia)
  • Oncology (UTUC imaging assessment; post-lobectomy adhesion prevention)
  • Metabolic monitoring (CGM in hemodialysis + diabetes)
  • Aesthetic dermatology (cheek wrinkles; crow’s feet)
• Clinical design signals:
  • Frequent use of randomization + blinding + sham/no-treatment controls → stronger bias control
  • Presence of multicenter + non-inferiority (confirmatory) design → regulatory-grade evidence generation
• Full dataset:
  • The full February 2026 MFDS medical device IND list is available for download on our website

Approvals by Device Category (What Was Approved)

February approvals can be organized into the following six device groups:

1. Electromyograph (EMG) System

• Evaluates whether neuromuscular electrical stimulation improves lower-limb strength and physical performance (walking speed, balance, sit-to-stand) in sarcopenia
• Single-center, randomized, double-blind, sham-stimulation controlled, exploratory

2. Central Circulatory Intravascular Ultrasound (IVUS) Catheter

• In UTUC, assesses tumor invasion depth by comparing OptiCross™ HD Coronary Imaging catheter images with pathological findings
• Prospective, single-center, investigator-initiated, exploratory

3. Personal Continuous Glucose Monitoring (CGM) System

• Validates accuracy of a CGM-based monitoring method in adults with diabetes who are receiving or initiating maintenance hemodialysis
• Multicenter, open-label, investigator-initiated, exploratory

4. General-Purpose Electrosurgical Unit (ESU)

• Assesses efficacy and safety for temporary improvement of mild–moderate bilateral cheek wrinkles
• Prospective, single-center, randomized, participant–assessor blinded, sham-device controlled, exploratory

5. Anti-Adhesion Barrier Coating Material (Guardix SG)

• In lung cancer patients undergoing lobectomy, evaluates anti-adhesion effect and safety after applying Guardix SG
• Single-blind, prospective, single-center, randomized, no-treatment controlled, superiority, investigator-initiated, exploratory

6. Biomaterial for Tissue Repair (Device Category)

• Compares CGAR002 (investigational device) vs. Rejuran (active comparator) for temporary improvement of bilateral crow’s feet wrinkles
• Multicenter, randomized, parallel-group, participant- and assessor-blinded, active-controlled, non-inferiority, confirmatory

February is not an “aesthetic-only” month. Approvals are distributed across rehabilitation/aging, oncology-related diagnosis and perioperative care, metabolic monitoring, and aesthetic dermatology—showing Korea’s capacity to support a broad medical device trial portfolio.

At the same time, several studies adopt sham controls + blinding + randomization, reflecting a clear push toward bias-controlled, evidence-driven trial designs in devices. The inclusion of a multicenter, non-inferiority confirmatory trial further signals movement beyond exploratory validation into submission-ready comparative evidence.

Notable Trial Design Signals

1. Active use of sham controls
   → A practical solution in device trials where placebo control is challenging, enabling clearer separation of treatment effect from bias.
2. Investigator-initiated exploratory studies (IITs)
   → Supports fast early evidence generation and a smoother path to later confirmatory expansion.
3. Emergence of multicenter + non-inferiority confirmatory framing
   → Indicates intent to generate evidence that is directly comparable to standard/competitor products—often essential for regulatory and market positioning.
4. Execution in operationally complex populations (hemodialysis, post-lobectomy)
   → Demonstrates Korea’s operational maturity for higher-burden settings and post-op outcome measurement.

Conclusion

MFDS approved 6 medical device clinical trial plans in February 2026, an increase from January’s 4. More importantly, February’s portfolio shows a clear emphasis on stronger evidence designs—including randomization, blinding, sham/no-treatment controls, and the inclusion of a multicenter, non-inferiority confirmatory trial. With approvals spanning rehabilitation, oncology, metabolic monitoring, and aesthetics, Korea continues to demonstrate a broad and scalable environment for medical device clinical development.

Planning a medical device clinical trial in Korea? From MFDS submission strategy and protocol design to site start-up and patient operations—we provide practical, execution-focused support to help you generate fast, credible evidence.