South Korea Diagnostic and Monitoring Devices Market Size and Forecast by Offering, Technology, Clinical Application, Distribution Channel, and End User: 2019-2033

---

Industry Assessment Overview

Industry Findings: Rapid regulatory and care-delivery shifts are realigning how devices reach end users — particularly via telemedicine and AI-enabled imaging. The emergency expansion to permit telemedicine more broadly (Feb-2024) accelerated payers’ and hospitals’ willingness to integrate remote monitoring devices into care pathways, increasing demand for validated home-monitoring kits and secure connectivity solutions across clinical networks.

Industry Progression: Regulators have followed with tightened quality and manufacturing rules: the MFDS consolidated K-GMP and device quality notices (Apr-2025) to raise manufacturing and post-market requirements for devices and IVDs. That Apr-2025 update increases audit expectations and pushes vendors to demonstrate stronger quality systems and local manufacturing credentials, reshaping supplier selection for Korean hospitals and exporters.

Industry Player Insights: South Korea’s market transformation is influenced by Samsung Medison, Seegene, Lunit, and GE HealthCare etc. Local champions are scaling capability: Samsung Medison’s strategic acquisition of Sonio (May-2024) deepened AI ultrasound capability while Seegene’s 2024 partnerships and expanded MFDS approvals (2024 filings) strengthened domestic molecular testing supply — these moves give Korean providers faster access to AI-enabled imaging and locally approved molecular assays, shaping procurement towards integrated, home-care ready solutions.