South Korea
South Korea Market Overview
South Korea is recognized for its advanced technology and innovative industry, making it a significant player in the global medical device and healthcare industry. The country offers a dynamic market environment for medical devices and diagnostics, driven by high healthcare standards and an aging population.
Market Size and Growth
In 2024, the projected revenue in the medical devices market in South Korea is expected to reach USD 7.08 billion. Among the various segments, the largest is cardiology devices, with a projected market volume of USD 1.01 billion in 2024. Looking ahead, the revenue is anticipated to demonstrate an annual growth rate (CAGR 2024-2029) of 7.72%, leading to a market volume of USD 10.27 billion by 2029. In a global comparison, the United States is expected to generate the highest revenue, amounting to USD 179.80 billion in 2024. South Korea’s market growth is driven by a strong healthcare infrastructure and a focus on technological innovation.
Customer Preferences
South Korean consumers have shown a growing preference for technologically advanced medical devices. They are willing to invest in devices offering innovative features, such as remote monitoring capabilities and artificial intelligence. This preference is driven by the country’s high smartphone penetration rate and the increasing popularity of wearable devices. Additionally, South Korean consumers value convenience and ease of use, which has led to a rise in demand for portable and user-friendly medical devices.
Trends in the Market
Increasing Number of Manufacturers: Alongside the growing domestic market, the number of medical device manufacturers has also been steadily increasing over the past decade.
COVID-19 Impact: The onset of the COVID-19 pandemic led to a rise in domestic and international demand for various medical devices.
Innovation and Advanced Technologies: Customer preferences in South Korea have been shifting towards more advanced and innovative medical technologies. This has led to a surge in demand for medical technologies such as robotic surgery systems, advanced imaging devices, and telemedicine solutions.
Our Services
Navigating the regulatory landscape in South Korea can be complex. Our team offers specialized services to help you succeed in this market:
We assist with the complete registration process for medical devices and in-vitro diagnostics (IVDs) with the Ministry of Food and Drug Safety (MFDS), including device classification into Class I, Class II, III, IV with or without Substantial Equivalent (S.E.), and streamlining Pre-Market Notification (PMN) and Pre-Market Approval (PMA). Our support extends to obtaining Korean Good Manufacturing Practice (KGMP) certification, facilitating local clinical trials in qualified clinical centers, and appointing a Korean License Holder (KLH) to fulfill local regulatory requirements. Additionally, we manage post-market surveillance activities such as sales data record-keeping and adverse event reporting to maintain compliance with MFDS regulations. Partner with us to ensure your medical devices meet South Korea’s regulatory standards and successfully penetrate the market.
Our Expertise
Our team of subject matter experts cover your complete product life cycle needs across key geographies from preclinical discovery, product design and validation documentation, QMS regulatory affairs, clinical research, QMS/GMP and cybersecurity etc. We are here to accelerate your key countries market access with one-stop solution.
