South Korea Country Commercial Guide
Learn about the market conditions, opportunities, regulations, and business conditions in South Korea, prepared by at U.S. Embassies worldwide by Commerce Department, State Department and other U.S. agencies’ professionals.
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Medical Equipment and Devices
Last published date:

Overview

Table: Medical Device Market Size
(Units: $ millions)

 2021202220232024
Total Local Production 11,25612,1868,6638,389
Total Exports8,6297,8755,1845,264
Total Imports5,3534,8884,7344,616
Imports from the US2,2142,2412,2132,123
Total Market Size7,9809,1988,2137,741

Source: Ministry of Food and Drug Safety

Despite the slowdown in the overall medical device market between 2021 and 2024, South Korea remains an attractive market for U.S. medical device companies. In 2024, imports from the United States accounted for 27.4% of the total Korean medical device market, reflecting the country’s continued reliance on advanced foreign technologies. This creates significant opportunities for U.S. companies, particularly in high-tech devices and niche market products.

The decline in Korea’s overall medical device production and exports during this period was largely attributable to the normalization of global demand for COVID-19 diagnostic products rather than broad weakness across the industry. Korea’s in vitro diagnostic (IVD) medical device industry experienced rapid growth from 2020 to 2022 following a surge in global demand for COVID-19 diagnostic kits, leading Korea’s medical device exports to exceed imports for the first time in 2020. Following the end of the pandemic, global demand for COVID-19 diagnostic testing declined by an estimated 70–90% from peak levels, resulting in a sharp contraction in Korea’s IVD-related production and exports beginning in 2023. Nevertheless, South Korea remains a global leader in diagnostic reagents, including high-risk pathogen immunoassays, genetic testing reagents, and immunoassay reagents for HIV, HBV, HCV, and HTLV.

Additionally, several non-IVD sectors—including digital health, dental, imaging, and beauty devices—continued to experience steady growth, with dental implants showing particularly strong increases in both domestic market share and exports. Although Korea’s total medical device market size declined from $8.2 billion in 2023 to $7.7 billion in 2024, total exports slightly increased from $5.18 billion to $5.26 billion during the same period, indicating continued strength in export-oriented medical device sectors outside of IVD products. This trend highlights South Korea’s strong manufacturing and export competitiveness across multiple medical device categories.

Between 2023 and 2024, the Korean medical device market demand decreased, primarily due to domestic factors. Hospital budgets were constrained amid the doctors’ strike that lasted until September 2025, which temporarily disrupted routine care and surgeries and reduced procurement of medical devices. In addition, broader economic pressures and cautious healthcare spending contributed to weaker domestic demand. However, industry experts expect the Korean medical device market to gradually recover beginning in 2026.

Sub-sector Best Prospects

  • Multifocal intraocular lens.
  • Soft contact lenses
  • Coronary artery stent. 
  • Disposable hand-controlled electrosurgical electrodes
  • CT systems.
  • Eyeglass lenses
  • MRI devices.
  • Hemodialysis machine and filter
  • Colonoscope
  • Esophagogastroduodenoscope (EGD)   
  • Internal knee prosthesis

Regulatory Environment

U.S. medical device manufacturers entering Korea must navigate the country’s pricing and reimbursement policies, which are closely tied to national healthcare cost containment. Importing devices requires appointing a local importer or representative with a physical address in Korea to manage regulatory compliance and pre-market approvals. Companies must submit safety and efficacy testing reports as mandated by the Ministry of Food and Drug Safety (MFDS), ensure compliance with Korean Good Manufacturing Practice (GMP) standards, and participate actively in pricing negotiations with the Health Insurance Review and Assessment Service (HIRA).

Coverage under the national health insurance system requires a new medical technology assessment or reimbursement determination, which involves demonstrating the clinical necessity and cost-effectiveness of the product. Even after approval, National Health Insurance Service (NHIS) and HIRA price negotiations take into account reference pricing, prices of similar products, and projected market share, making careful pricing strategy and market analysis essential.

Another key consideration for the Korean medical device market includes compliance with the medical device license renewal system, which requires manufacturers and importers to renew approvals, certifications, or notifications every five years, effective in 2025.

Awareness of these Korean policies, systems and early preparation are essential for successful market entry.

Opportunities

The United States is South Korea’s most prominent foreign supplier of medical devices by dollar value, with Germany, Japan, and China following. Korean companies generally manufacture less advanced or mid-range medical devices; therefore, Korea depends on the United States, Europe, and Japan to supply high-tech medical devices.  Conversely, China supplies low-end medical devices and economical consumables in Korea, making it difficult for U.S. companies to compete with Korean and Chinese companies in mid-range to low-end segments due to higher prices. Additionally, South Korea’s pricing program requires companies to justify higher reimbursement rates for medical devices by proving long-term cost-effectiveness. As a result, premium U.S. products, which tend to be priced higher than those of competitors, often face challenges entering the Korean market. Nevertheless, high-tech U.S. medical devices with no direct competition have strong market potential in Korea.

As Korea establishes itself as a leading exporter of medical devices, the Korean government is actively supporting domestic companies in their efforts to expand into the global markets. This growing international focus creates valuable opportunities for U.S. healthcare consulting firms to provide expertise in clinical research, product registration, medical device licensing, market access, and commercialization, facilitating Korean companies’ entry into the U.S. and other global markets. 

Unlike other advanced economies, Korea lags in telehealth adoption due to the lack of a legal framework, largely influenced by opposition from medical doctors and civic groups. Under the current Medical Services Act, “Remote Medical Treatment” is only permitted among healthcare professionals, thus prohibiting direct patient-doctor consultations via ICT tools. However, in response to limited healthcare access during emergency situations, temporary allowances for teleconsultations between patients and doctors were made during the COVID-19 pandemic (2020–2023) and again in February 2024 amid the doctors’ strike, which ultimately ended in September 2025. Currently, the Korean government is making efforts to legalize it through an amendment to the Medical Service Act, which is scheduled to take effect in December 2026.  However, the legislation mainly provides a legal foundation for pilot projects that had previously operated in a regulatory gray area. Even after December 2026, telehealth services may continue to be limited to pilot projects until detailed enforcement decrees, regulations, and reimbursement policies are established. Industry experts anticipate opportunities for remote patient monitoring manufacturers and digital therapeutics providers once the regulatory framework is fully implemented.

In addition, the demand for medical AI is expected to grow, as evidenced by the recent AIRIS meeting hosted by the Korean MFDS in September 2025, which brought together global regulatory authorities to discuss AI in healthcare. The administration’s goal of making Korea one of the top three AI nations further supports the outlook for AI-driven healthcare technologies.

Therefore, it is important for U.S. companies to closely monitor legislative and regulatory developments in Korea to quickly adapt their market entry strategies and capitalize on emerging opportunities in both telehealth and medical AI.

Resources

Trade Shows

  • Korean International Medical & Hospital Equipment Show (KIMES)
    March 18~21, 2027
    COEX
  • BIO Korea International Convention
    Spring 2027
    COEX
  • K-Hospital Fair 
    Aug 19~21, 2026
    COEX
  • Bioplus Interphex Korea (BIX)
    October 28-30, 2026
    COEX

Key Contacts

 

Local Contact

U.S. Commercial Service Korea    
U.S. Embassy Seoul
188 Sejong-daero, Jongro-gu
Seoul 03141, Korea
Tel: 82-2-397-4535
office.seoul@trade.gov
https://www.trade.gov/south-korea

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