The data provided show that a total of 160 investigational medical devices were approved in 2024. Monthly approvals ranged from 20 in January to six in August, with 19 approvals in March and 18 in June. After dipping to six in August, monthly approvals returned to double digits for the remainder of the year. Variations in timing may reflect submission schedules, review durations and the complexity of different device types.
Software-Based Devices and Top Categories
Software‑based devices dominated the approval list. The table below highlights the leading categories.
| Item | Number of approvals | |
| Cognitive therapy software | 11 | |
| Bio‑material for tissue repair | 6 | |
| Biosignal analysis software | 6 | |
| Brain imaging detection/diagnostic software | 5 | |
| Electrocardiogram analysis software | 5 | |
| Brain‑stimulating device for psychotherapy | 5 | |
Other approved devices included pulmonary disease risk‑assessment software, gastric cancer imaging diagnostic support systems, continuous glucose monitoring systems and silicone‑gel breast implants. Software‑based products accounted for more than half of all approvals, underscoring the rise of digital health technology in device development.
Regulatory Landscape and Outlook
Digital health products can be updated via software, which makes post‑market surveillance and cybersecurity essential. Korea’s Digital Medical Products Act (effective January 2025) establishes a comprehensive framework for digital therapeutics and AI‑based medical devices, and MFDS is continually refining cybersecurity and AI guidance. The 2024 approval report offers an analytical breakdown of approvals by device type and signals future regulatory directions.
Globally, authorities are strengthening digital‑health regulation. The U.S. FDA introduced the cycle‑by‑cycle approach for SaMD updates, and the EU’s Medical Device Regulation and upcoming AI Act emphasize cybersecurity and clinical evidence for SaMD. Korean developers must align their trial design and quality systems with these international benchmarks to remain competitive.
Implications for Biomedical Stakeholders
Approvals of investigational medical devices reflect domestic innovation capacity. Digital therapeutics addressing neurological, cardiovascular and mental‑health indications meet growing societal needs and will likely continue to drive clinical trial activity. International sponsors considering Korea can benefit from high‑quality infrastructure, rapid participant recruitment and regulatory support. Domestic firms should focus on competitive niches such as cognitive‑therapy software and biosignal analysis software while adhering to MFDS guidelines to facilitate global trials and technology transfer.
Our firm provides comprehensive support for MFDS IND strategy, clinical‑trial design and regulatory consulting. If you are preparing an investigational medical device trial, request a quote for customized assistance. Subscribe to our newsletter to receive regular updates on digital health and medical device approval trends. We welcome engagement from biomedical professionals worldwide.
