During November 2025 the Korean Ministry of Food and Drug Safety (MFDS) issued just four approvals for investigational medical device trials, but each case provides a valuable glimpse into the direction of Korea’s medtech innovation. This article uses MFDS IND approvals as the main keyword, examining the purpose of each trial, its design, and domestic and global trends. The focus on digital therapeutics for rehabilitation and non‑invasive neurostimulation underscores the potential impact of these approvals on the future medical device market.
Bioprosthetic Tricuspid Valve – A New Hope for Patients with Severe Regurgitation
The first approval on 14 November covers a clinical trial applying percutaneous caval valve implantation (CAVI) for patients with severe tricuspid regurgitation who are not eligible for open‑heart surgery. Tricuspid regurgitation results when the valve between the right atrium and right ventricle fails to close properly, causing reverse blood flow that can lead to heart failure, liver enlargement and ascites. Traditional treatment involves open‑chest surgery to insert a prosthetic valve, a high‑risk procedure for elderly patients.
This study uses a catheter‑based approach, placing the PULSTA valve in the vena cava without opening the heart. The device, made from biocompatible materials such as polyurethane and nitinol, is anchored in the vena cava to reduce regurgitation. The exploratory, single‑arm, multi‑center trial plans to enroll at least 30 patients and follow them for 12 months. Endpoints include quality of life, exercise capacity and hemodynamic parameters. Global demand for non‑surgical options in structural heart disease is rising and the trial may pave the way for a larger pivotal study and strengthen domestic capabilities in a field long dominated by imports.
Rehabilitation Software – Expanding Digital Therapeutics for Orthopedic Patients
The second approval, also granted on 14 November, concerns a pivotal trial of Exercite Rehab, a digital therapeutic designed to shorten recovery time and improve functional mobility after hip or knee replacement surgery. Many patients find it difficult to attend frequent physical therapy sessions due to travel and cost; remote programs can fill that gap.
Exercise Rehab delivers rehabilitation via smartphone or tablet. Artificial‑intelligence algorithms analyze patient movement through motion sensors and cameras and adjust exercise intensity and posture in real time. Gamified interfaces, points and social competition encourage adherence. The randomized, open‑label study will compare the software‑based program to standard physical therapy.
The trial will collect data on pain reduction, range of motion, patient satisfaction and other metrics to validate clinical efficacy. Digital therapeutics are gaining attention because they help optimize hospital resources and empower patients to manage their care. Global markets have already approved products for respiratory disease, diabetes and mental health, and Korea has introduced new guidelines and regulatory support for digital medical devices. Given that 10 of the 16 device trials approved by MFDS in the first half of this year were digital, the November approval signals continued regulatory interest in digital health.
Facial Tissue Fixation Thread – Comparing Safety and Efficacy in Aesthetic Medicine
The third approval, dated 11 November, focuses on a new facial tissue fixation thread called miniting for improving the depth of nasolabial folds. Unlike the widely marketed MINT Lift®, miniting uses a novel barbed structure and biocompatible materials to grip subcutaneous tissue and fascia more securely. The multicenter, randomized, participant‑ and assessor‑blinded, active‑controlled trial will enroll more than 200 participants and assess both non‑inferiority and superiority against the comparator.
Thread‑lifting procedures are popular among patients in their 30s to 50s because they avoid large incisions and require only local anesthesia. However, edema, infection and asymmetrical have been reported, highlighting the need for product‑specific safety data. Miniting’s patented serrated design aims to increase tissue anchoring while reducing pain during insertion. Outcome measures include wrinkle depth reduction, patient satisfaction and adverse event rates over a 12‑month follow‑up. Positive results could open overseas markets for a home‑grown device and strengthen Korea’s position in the global aesthetic market.
Neurostimulation Device for Psychotherapy – A Non‑Invasive Approach to Cognitive Improvement
The fourth approved study, on 10 November, explores a device that combines galvanic vestibular stimulation (GVS) with transcranial direct current stimulation (tDCS) to enhance cognitive function in patients with mild cognitive impairment and early dementia. GVS applies electrical stimulation behind the ears to activate the vestibular nerves, while tDCS delivers a low current to the cerebral cortex through the skull to modulate neuronal excitability and plasticity.
Non‑invasive brain stimulation is gaining attention for conditions that respond poorly to pharmacotherapy. Internationally it has been trialled for depression, Parkinson’s disease, chronic pain and fibromyalgia, and some devices have US FDA clearance for home use. The Korean study will assess whether simultaneous vestibular and cortical stimulation can improve balance and spatial cognition. Although the sample size is small, the protocol includes cognitive assessments as well as biomarkers such as EEG and functional MRI. Success could lead to multimodal strategies that complement drug therapy and set a new standard in dementia care.
The MFDS IND System and Policy Trends
Korea’s IND system for medical devices mirrors the US FDA process by assessing safety and scientific validity before clinical trials begin. Unlike drugs, devices must be evaluated for mechanical and software reliability, user training requirements and other factors. Introduced in 2002, the system has seen steady growth and reportedly approved more than 700 trials in 2022. Recent legislation – including the Medical Device Act and the Digital Healthcare Products Act – has created a more systematic environment for trials, and local governments and hospitals are using regulatory sandboxes to support device testing.
Regulators have also established consultation programs and guidelines that help startups and mid‑size firms design trials that meet international standards. This has encouraged multinational companies to consider Korea as a clinical trial hub. Although no foreign‑sponsored trials were approved in November, global interest is expected to rebound as economic conditions improve and trade agreements evolve.
Outlook and Conclusions
The November approvals show that cutting‑edge technologies such as digital therapeutics and bioprosthetic implants are rapidly entering clinical practice. Personalized treatments and non‑invasive modalities will likely improve quality of life and therapeutic efficiency. Hospitals and companies must rigorously analyze trial data to demonstrate safety and efficacy, while regulators should foster innovation and maintain robust oversight.
At the same time, pharmaceutical and biotech professionals need to monitor MFDS developments closely. Requirements for digital therapeutics, data security, privacy and telemedicine policies directly influence trial design and business models. Conducting successful trials in Korea enhances credibility for global market entry and foreign investment. Firms should establish dedicated teams to track regulatory updates, cultivate international partnerships and manage clinical data proactively.
Finally, the November approvals offer insight not only for device developers but also for investors and academia. When trial results are published, sharing lessons learned can strengthen the entire industry’s capability. We hope this article aids your strategic planning. The blend of policy change and technological progress seen in November 2025 underlines the potential of Korea’s medical device sector and is likely to spur greater collaboration between domestic and international trials.
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