Korea’s medical device industry and biopharmaceutical ecosystem are facing a major paradigm shift starting in 2026. The Ministry of Food and Drug Safety (MFDS) has fully implemented the ‘Digital Medical Products Act (DMPA)’ and the completely revised ‘Regulations on Approval, Notification, and Review of Medical Devices (Notice 2026-6)’ to support the rapid commercialization of innovative medical technologies and achieve global regulatory harmonization. This reorganization of the regulatory infrastructure requires fundamental changes in how Clinical Trials are designed and conducted for advanced complex products, such as Software as a Medical Device (SaMD), In Vitro Diagnostics (IVD), and Artificial Intelligence (AI)-based diagnostic support solutions.
The new regulatory framework elevates the Safety and Efficacy Review (SER) requirements to align with International Medical Device Regulators Forum (IMDRF) standards. Meanwhile, it establishes an ‘Immediate Market Entry’ pathway for devices meeting specific criteria, allowing them to be introduced into clinical practice immediately after the conclusion of Clinical Trials by deferring the Health Technology Assessment (HTA). This report analyzes the status of key medical device Clinical Trials approved by the MFDS during September 2026 and provides an in-depth review of the clinical value of each study alongside the shifting 2026 regulatory landscape.
Status of Key Medical Device Clinical Trials Approved by MFDS in September 2026
During September 2026 (2026-09-01 ~ 2026-09-30), the MFDS approved crucial Clinical Trials across various fields, including neuroscience, non-invasive vital sign monitoring, and tissue repair. These products directly target unmet medical needs in their respective fields, sharing a common goal of demonstrating both innovation and safety through rigorous Clinical Trial Protocols.
Check the Medical Device MFDS Approval Status (2026-09-01~2026-09-30)
Table 1: Key Medical Device Clinical Trials Approved by MFDS in September 2026
|
NO |
Product Name |
Clinical Trial Title |
Approval Date |
|
1 |
Cortical electrode |
A prospective, single-center, non-randomized, open-label, single-arm investigator-led exploratory Clinical Trial to evaluate the safety and performance (signal acquisition) of high-density ECoG electrodes (cortical electrodes) in patients with drug-resistant focal epilepsy. |
2026-09-16 |
|
2 |
Device for testing internal functions (EDL Doctor Terrapay) |
A multi-center, open-label, single-arm, prospective confirmatory Clinical Trial to evaluate the performance and safety of the PPG-based non-invasive medical device ‘EDL Doctor Terrapay’ in confirming blood glucose levels and trends. |
2026-09-17 |
|
3 |
Brain electrical stimulator for psychotherapy (YMS-201B) |
A randomized, double-blind, placebo-controlled, parallel-design, investigator-initiated exploratory Clinical Trial to obtain preliminary clinical evaluation data on the effects of gamma-tACS (YMS-201B) on cognitive function improvement in patients with amnestic mild cognitive impairment. |
2026-09-21 |
|
4 |
Biomaterials for tissue repair (RBMD-404-01) |
A multicenter, randomized, evaluator-subject-blind, active-control, paired, non-inferiority, confirmatory Clinical Trial to evaluate the efficacy and safety of RBMD-404-01 for the temporary improvement of crowding lines (crow’s feet) compared to a control device (Rejuran HB plus®). |
2026-09-29 |
The data presented in the table above shows that sponsors are employing differentiated Clinical Trials strategies tailored to the characteristics of their products. The following section analyzes the technological mechanisms of each approved product and the validity of the Clinical Trial designs intended to prove them.
In-depth Analysis of Technological Mechanisms and Clinical Trial Designs
High-Density Cortical Electrode for Epilepsy Network Mapping
Drug-resistant focal epilepsy is a severe disease accounting for about 30% of all epilepsy patients. Because it does not respond to anti-seizure medications, surgical resection of the epileptogenic zone or the implantation of cranial nerve stimulators is essential. In this process, intracranial EEG measurements using cortical electrodes (ECoG) are performed to accurately map the origin of seizures and the cerebral cortex network.
The exploratory Clinical Trial of the high-density ECoG electrode, approved on September 16, aims to improve the accuracy of epilepsy surgery by maximizing resolution and signal acquisition performance. Traditional ECoG electrodes have struggled to capture minute EEG signals due to limitations in spatial resolution and impedance issues. Furthermore, studies on channel selection models based on genetic algorithms have pointed out that a significant number of implanted electrodes (e.g., 32 channels) are often classified as noise and excluded from analysis.
This Clinical Trial verifies the performance of acquiring spatiotemporal high-frequency oscillations (HFOs) and epileptiform waveforms through a high-density array (HD ECoG) ranging from 64 to 128 channels. If this prospective, single-arm Clinical Trial yields successful data, it will serve as a milestone for subsequent Clinical Trials aimed at applying next-generation hardware technologies, such as the biodegradable polyurethane (PPU)-based brain-adhesive molybdenum (Mo) biosensors recently developed by leading Korean researchers.
Breaking the Limitations of PPG-based Non-invasive Glucose Monitors (EDL Doctor Terrapay)
The confirmatory Clinical Trial of ‘EDL Doctor Terrapay’, approved on September 17, explores the commercial viability of Non-Invasive Glucose Monitoring (NIGM) technology, which is highly anticipated by the global diabetes management market. Developed by Software Convergence Institute Co., Ltd. (SCI), this device estimates blood glucose levels by analyzing hemodynamic signals collected via photoplethysmography (PPG) sensors using an AI-based machine learning model.
In 2024, the US FDA issued a safety communication strongly warning that non-invasive glucose devices in the form of smartwatches or smart rings have not yet been medically verified, and that inaccurate measurements could lead to incorrect insulin administration. Indeed, numerous studies have shown that optical-based non-invasive devices struggle with accuracy, failing to meet the international standard ISO 15197:2013 (over 95% agreement within ±15 mg/dL for glucose <100 mg/dL, and ±15% for ≥100 mg/dL), and exhibiting errors in the clinical risk zones (Zone C or worse) in Consensus Error Grid analyses.
However, the approval of this confirmatory Clinical Trial indicates that the MFDS positively evaluated the clinical potential of this technology. Recent advanced PPG models have incorporated individual biometric parameters, such as fingertip thickness, skin condition, and Body Mass Index (BMI), as correction variables. This has led to encouraging research results, lowering the Mean Absolute Relative Deviation (MARD) to 8.8% and placing 100% of measurements in the safe zones (Zone A and Zone B) of the Consensus Error Grid. Therefore, this study will be a crucial confirmatory Clinical Trial evaluating whether such advanced AI algorithms can consistently guarantee in vitro diagnostic device-level accuracy in real-world settings.
Randomized Placebo-Controlled Clinical Trial of Gamma-tACS Neuromodulation (YMS-201B)
The Clinical Trial for Ybrain’s YMS-201B, approved on September 21, is an exploratory Clinical Trial verifying the cognitive improvement effects of gamma-band transcranial alternating current stimulation (gamma-tACS) in patients with amnestic mild cognitive impairment (aMCI).
Neural oscillatory networks essential for maintaining normal brain function, particularly gamma-band synchronization in the 30-80Hz range, show a distinct decline in patients with Alzheimer’s disease (AD) and mild cognitive impairment. The YMS-201B operates on the principle of non-invasively applying alternating current to the scalp to resynchronize (entrainment) the rhythms of the brain’s neural network, thereby inducing synaptic plasticity.
Notably, the strict adoption of a randomized, double-blind, placebo-controlled design in this Clinical Trial serves as an exemplary model for Clinical Trials involving neuropsychiatric disorders. In the field of neuromodulation and electroceuticals, the placebo effect—arising from the patient’s and evaluator’s awareness of the stimulation—greatly impacts the results. Thus, only a sophisticated Clinical Trial Protocol that sets a sham stimulation as a control group and maintains blinding can isolate the true physiological efficacy of the therapeutic device. The MFDS has recently refined Clinical Trials guidelines related to Digital Therapeutics (DTx), and the results of this exploratory Clinical Trial will provide the essential dataset (e.g., effect size calculation and optimal stimulation parameters establishment) required to design large-scale confirmatory Clinical Trials for this class of devices.
Paired Non-inferiority Clinical Trial for Tissue Repair Biomaterials (RBMD-404-01)
The confirmatory Clinical Trial for RBMD-404-01, approved on September 29, demonstrates advanced Clinical Trials methodologies in the aesthetic medical device sector. This study aims to verify non-inferiority against an active control group, the previously approved Rejuran HB plus®, for the improvement of crow’s feet.
One of the greatest hurdles in Clinical Trials for tissue repair biomaterials is that inter-subject variability—such as individual skin thickness, degree of aging, and anatomical structure—interferes with result interpretation. To control for this, the Clinical Trial introduced a ‘paired design’. This approach establishes a perfect self-control environment by randomly injecting the investigational device and the control device into the left and right sides of each subject’s face, respectively.
Such a design can statistically reduce the total sample size required for Clinical Trials, shortening R&D costs and time. At the same time, it is the most intuitive and scientific Clinical Trial strategy to prove that a newly developed biomaterial performs equally to or better than existing dominant products in the market.
2026 Regulatory Framework Reorganization: The Impact of Notice 2026-6 and DMPA on Clinical Trials
For the advanced technology-based medical devices analyzed above to successfully settle into clinical practice, a clear understanding of Korea’s macro-regulatory changes implemented in January 2026 is essential. Through the ‘Amendment of the Regulations on Approval, Notification, and Review of Medical Devices (Notice 2026-6)’ and the ‘Digital Medical Products Act (DMPA)’, the MFDS unified device classification standards with the IMDRF system and established flexible yet strict evaluation criteria for clinical evidence.
Table 2: Major Changes in the Clinical Trials Review System Following the Implementation of MFDS Notice 2026-6
|
Regulatory Category |
Previous Framework |
Updated Framework (Notice 2026-6 & DMPA) |
Impact on Clinical Trials |
|
Scope of Acceptable Clinical Data |
Centered on domestic confirmatory Clinical Trials |
Comprehensively accepts MFDS-designated Clinical Trials, OECD-notarized clinical data, SCI/SCIE published literature, and RWE-based Clinical Evaluation Reports (CER) |
Facilitates bridging and cross-approval of global Clinical Trials data; reduces the burden of duplicate Clinical Trials on sponsors. |
|
Digital Health & SaMD |
Relied on case-by-case authoritative interpretation |
Established official definition of SaMD; mandated cybersecurity and risk management plans based on DMPA |
Mandatory submission of control documents for network security and cloud data integrity during AI software Clinical Trials |
|
Product Grouping & Equivalence |
High room for reviewer discretion |
Codified strict bundling and ‘same product group’ criteria for software versions and components |
Simple changes skip Clinical Trials; clear criteria for additional Clinical Trials are provided when core algorithms are altered. |
|
Expedited Review Pathway |
Complex HTA procedures accompanied even after innovative device designation |
Operates a 240-day approval target and ‘Immediate Market Entry’ pathway for specific indications |
Commercialization possible within 80-140 days after Clinical Trials end. However, it requires a significantly higher statistical and clinical burden of proof in the initial Clinical Trial Protocol. |
Innovative Expansion of the Acceptable Scope of Clinical Trial Data
The most crucial change in Notice 2026-6 is the extensive diversification of clinical data formats accepted during the ‘Safety and Efficacy Review (SER)’. Previously, prospective Clinical Trials conducted domestically formed the backbone. Now, overseas Clinical Trials data deemed compliant with Korea’s GCP (Good Clinical Practice) standards, data reviewed in OECD member countries, and research results published in credible medical journals (SCI/SCIE) are recognized as equivalent clinical evidence.
Furthermore, the utilization of retrospective observational studies and Clinical Evaluation Reports (CER) based on Real-World Data (RWD) and Real-World Evidence (RWE) has been officially expanded. This means that if substantial equivalence to a predicate device is proven, companies do not need to unreasonably repeat costly and time-consuming prospective Clinical Trials. Instead, they can pave the way for approval using only retrospective literature reviews and post-market surveillance data.
Digital Medical Products Act (DMPA) and Cybersecurity-Centric Clinical Trials
The Digital Medical Products Act (DMPA) and the AI Basic Act, which came into effect in January 2026, added a new hurdle called ‘cybersecurity’ to the design of Clinical Trials for digital medical devices. In conjunction with Notice 2026-6, all medical devices utilizing wired/wireless communication functions or cloud infrastructure (e.g., the aforementioned non-invasive glucose monitor or remote data-collecting ECoG) must include a cybersecurity risk assessment, threat model, and vulnerability management plan in their regulatory submission documents.
In the process of conducting Clinical Trials themselves, preserving patient data integrity and deploying hacking defense systems have emerged as critical pillars of GCP requirements. This emphasizes that Contract Research Organizations (CROs) and Clinical Trial Management System (CTMS) providers must adhere to international security standards (such as ISO 27001) and maximize real-time audit trail functions to mitigate sponsors’ regulatory risks.
The ‘Immediate Market Entry’ Pathway and the Paradox of Clinical Trials Advancement
The ‘Market Immediate Entry Medical Technology’ system, implemented in January 2026 to facilitate the early market entry of innovative medical technologies, acts as a double-edged sword for Clinical Trials strategies. For 199 designated items—including AI-based SaMD, digital therapeutics, and certain in vitro diagnostics—devices can be prescribed to patients in medical institutions as non-reimbursed items for up to three years immediately upon MFDS approval. The commercialization period, which previously suffered delays of up to 490 days through HIRA and NECA, has been drastically cut to 80-140 days.
Paradoxically, to enjoy the benefits of this early market entry, the burden of proof regarding efficacy and safety required during the Clinical Trials phase for initial approval has become much heavier. In exchange for temporarily deferring a separate clinical Health Technology Assessment (HTA), regulatory authorities demand robust data that perfectly proves the product’s clinical benefit-to-risk ratio during the initial Clinical Trials phase. To gain the strategic advantage of rapid revenue generation, sponsors must design much more meticulous Clinical Trial Protocols from the planning stage, increasing statistical power and diversifying exploratory endpoints.
Infrastructure Convergence: Incheon Bio Cluster and Next-Generation Clinical Trials Infrastructure
Korea’s infrastructure supporting the Clinical Trials ecosystem is also advancing. The bio-cluster centered around Songdo, Incheon, is establishing itself as a global research hub for cell and gene therapies and advanced complex medical devices, driven by large-scale production facility expansions by major CDMO companies like Samsung Biologics, SK Bioscience, and Lotte Biologics.
This expansion of physical infrastructure synergizes with the evolution of advanced CTMS (Clinical Trial Management System) solutions. Recently, Korea’s excellent Clinical Trials infrastructure introduced the HL7 FHIR (Fast Healthcare Interoperability Resources) standard, reaching the level of automatically extracting information from hospitals’ Electronic Health Record (EHR) systems directly into Clinical Trials Electronic Data Capture (EDC) platforms. This environment accelerates patient enrollment requirements and can reduce the overall duration of Clinical Trials execution by 6 to 18 months. The combination of an outstanding investigator pool and a high-density hospital infrastructure makes Korea’s Clinical Trials environment an optimal testbed for multinational Clinical Trials by global sponsors.
Strategic Recommendations for Sponsors in 2026
Synthesizing this analysis, domestic and foreign biopharmaceutical and MedTech sponsors should establish the following Clinical Trials optimization strategies:
- Early Regulatory Pathway Mapping and Active Use of Pre-Submission Consulting: As product grouping and equivalence criteria have become clearer under Notice 2026-6, sponsors should thoroughly explore the feasibility of using literature-based CER before blindly initiating prospective Clinical Trials. If new Clinical Trials are unavoidable, it is essential to utilize the MFDS’s pre-consultation system to establish the regulatory conformity of the Clinical Trial Protocol in advance.
- Phased Introduction of RWE-based Decentralized Clinical Trials (DCT): Post-market Clinical Trials for wearable devices or digital healthcare devices must be specialized for Real-World Data (RWD) collection. A system architecture must be secured that refines patients’ real-life data into Clinical Trials data by equipping cloud-integrated CTMS and remote monitoring systems.
- Integrated Management of Cybersecurity and QMS: Even minor software updates or algorithm changes in devices require strict change management based on ‘same product group’ criteria. Throughout the execution of Clinical Trials and the post-market phase, sponsors must continuously update cybersecurity threat models and proactively meet ISO 13485-based KGMP requirements.
The medical device approval status and the latest regulatory infrastructure as of September 2026 clearly demonstrate that Korea is leaping beyond a mere adopter of medical technology to become a standard-setting leader presenting innovative Clinical Trials methodologies to the global market. Amidst an inherently uncertain regulatory environment, only companies equipped with rigorous validation logic and agile Clinical Trials strategies will seize dominance in the next-generation global biohealth ecosystem.
[Global Medical Device Clinical & Regulatory Strategy Consulting]
In the highly restructured Korean regulatory environment of 2026, our expert group proposes optimal Clinical Trials designs and regulatory pathways to minimize the uncertainties facing your innovative products and assist in successful commercialization.
- Request a Quote: Apply now for a quote on customized Clinical Trials protocol design and regulatory strategy consulting that reflects Notice 2026-6 and Immediate Market Entry requirements.
- Subscribe to Newsletter: Be the first to receive the latest MFDS guideline changes, major global Clinical Trials case studies, and in-depth regulatory analysis reports delivered straight to your inbox every month.
(If you leave your contact information via the ‘Contact Us’ or ‘Subscribe’ button on our website, our dedicated experts will reply promptly.)