MFDS medical device approvals June 2025

Introduction

The MFDS clinical trial approvals in June 2025 provide valuable insight for domestic and international pharmaceutical and biotech professionals. During this one‑month period, Korea’s Ministry of Food and Drug Safety approved 14 investigational medical devices spanning AI‑based vital‑sign analysis software, novel vascular catheters, lasers, ultrasound devices and digital therapeutics. This article introduces the approved products and examines the MFDS review process and recent policy changes that may affect future submissions.

MFDS approval process for medical devices

Before a company can manufacture or import a medical device in Korea, the MFDS requires a dossier of technical documents covering performance, safety and intended use. Class I and II devices are typically certified by the Medical Device Information & Technology Assistance Center or the National Institute of Medical Device Safety Information, while Class III and IV devices require direct MFDS approval. However, certain Class I/II devices—those requiring clinical trial data, involving digital healthcare (e.g., telemedicine systems), lacking clear nomenclature or combining pharmaceuticals—must also undergo MFDS approval. Devices are stratified into four risk classes, and higher‑risk products face more rigorous review and external expert consultation.

Summary of devices approved in June 2025

The 14 approvals highlight the diversity of Korea’s med‑tech pipeline. Key products include:

1. Vital‑PICASO vital‑sign analysis software: AI software that analyzes ward patients’ vital signs (SBP, DBP, HR, RR, BT, SpO₂) to predict cardiac arrest, hypotension or hypoxemia within 24 hours. These retrospective, single‑arm, superiority trials assess its clinical utility.
2. GENOSS® SCB balloon‑expandable coronary angioplasty catheter: A multicenter, randomized, active‑controlled, non‑inferiority trial compares late lumen loss in de novo coronary lesions (2.25–2.75 mm vessels) against Sequent® Please NEO.
3. HIPLA tissue reconstruction material: A 52‑week, multicenter, double‑blind trial evaluates the temporary improvement of moderate to deep nasolabial folds and safety profile.
4. MINT Lift FINE+ vs. CGAG001 facial suspension threads:  A multicenter, randomized, participant‑ and assessor‑blinded trial compares the non‑inferiority of these devices for reducing bilateral nasolabial wrinkles.
5. Picocare Majesty™ Nd:YAG laser:  A single‑arm exploratory study examines the therapeutic efficacy and safety of a 532 nm Nd:YAG picosecond laser for facial pigmented lesions.
6. Focused ultrasound stimulation system (NS‑US200):  An exploratory study injects SonoVue and targets the left dorsolateral prefrontal cortex to evaluate blood–brain barrier opening and safety in Alzheimer’s disease patients.
7. Medical laser irradiation device: A controlled, evaluator‑blinded, randomized trial explores safety and short‑term pain control in idiopathic Parkinson’s patients with chronic nonspecific low back pain.
8. 4DEYE DTx musculoskeletal rehabilitation software:  A single‑center, prospective, superiority trial assesses pain reduction in chronic knee‑pain patients using a digital therapeutic.
9. Angiomics ER cardiovascular imaging and diagnostic‑aid software: A single‑arm, retrospective study evaluates the software’s ability to detect ≥50% stenosis in major coronary arteries using curved MPR images.
10. CartiFix surgical product:  A multicenter, evaluator‑blinded exploratory trial with a four‑year follow‑up determines the evaluation method and initial safety of injecting CartiFix following microfracture surgery for knee cartilage lesions.
11. RBMD‑404‑01 tissue‑regeneration biomaterial: A randomized, assessor‑ and subject‑blinded, parallel‑design exploratory trial evaluates efficacy and safety for bilateral crow’s feet.

1. Soricle physical‑therapy device:  A prospective, randomized, double‑blind, sham‑controlled trial investigates the efficacy and safety of a non‑pharmacological device for chronic insomnia.

Full English titles and details of these trials are available in the attached Excel file. The translated sheet lists each device, clinical trial title and approval date for ease of reference.

Regulatory updates and implications

In June 2025 the MFDS released the fourth revision of its pre‑consultation guideline for innovative products, explicitly including digital medical devices. Software as a medical device (SaMD), AI‑based diagnostics and mobile health applications are now eligible for early dialogue with regulators. This change follows enactment of the Digital Medical Products Act and demonstrates Korea’s commitment to integrating digital health into its regulatory framework. By engaging in pre‑consultation, developers can obtain non‑binding regulatory feedback, clarify device classification and streamline subsequent submissions.

The MFDS also emphasizes the submission of clinical trial data when a device’s intended use, mechanism of action or raw materials differ from existing products. External experts participate in the review of higher‑risk or novel devices to ensure safety and effectiveness. For companies developing AI‑driven or combination devices, early alignment with these requirements can reduce approval timelines and enhance global competitiveness.

Industry outlook

June’s approvals illustrate the convergence of traditional medical devices and digital therapeutics. AI‑enabled monitoring software, musculoskeletal rehabilitation apps and non‑drug devices for insomnia reflect Korea’s growing emphasis on digital health innovation. At the same time, interventional tools such as coronary catheters and focused ultrasound systems indicate ongoing investment in high‑risk, high‑impact therapies. As Korea positions itself as a global hub for med‑tech innovation, domestic and foreign companies should track MFDS approval trends and leverage the pre‑consultation program as a strategic resource.

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