Korea - Medical Equipment and DevicesKorea - Medical Equipment and Devices

ITA CODE:  PR MED

Overview

Medical Device Market Overview - By Year                                                          Unit: $1 million

Source: MFDS (Ministry of Food and Drug Safety), the Bank of Korea
Note: Market size = Production - Exports + Imports
According to the Ministry of Food and Drug Safety (MFDS), the market size for the medical device sector in South Korea has doubled since 2010. Ranked 9^th in the world in 2018, Korea’s market reached approximately $6.2 billion in 2018 and imports from the U.S. increased from 0.9 billion in 2010 to $1.8 billion in 2018.
To successfully identify business opportunities, it is essential to take a closer look into the unique aspects of Korea’s medical device market. The ratio of local production to imports has been steady at less than 40 percent over the past decade. In addition, nearly 80 percent of South Korean medical device manufacturers are small- and medium-sized enterprises (SMEs) with less than $1 million in revenue. South Korea’s medical devices are classified into the four categorical levels according to the product’s purpose and the degree of potential risk. As of 2018, over 65 percent of Korean medical device manufacturers are producing relatively low-risk medical devices (level 1 and 2).
In other words, South Korean companies make comparatively lower-end (mid-technology) medical devices. Therefore, market demand for high-end medical devices relies on imports. Among the list of importing countries in 2018, the U.S. consists of nearly half (47 percent) of total imports, followed by Germany (17 percent), and Japan (10 percent).
The List of Top 5 Imports for Medical Device Products - By Year
Unit: $1 thousand

Source: MFDS (Ministry of Food and Drug Safety)

Sub-Sector Best Prospects

• Soft contact lenses

• Intravascular catheters

• Dialyzers for hemodialysis

• IVD reagents for clinical immunochemistry

• Knee joint prostheses

• MRI devices

• CT systems

• Sight corrective ophthalmic lenses

• Staples for internal use (non-absorbent)

• Analyzing products

Regulatory Environment

The importation of medical devices requires the assignment of an importer or representative based in South Korea to manage medical device approvals and to ensure regulatory compliance. As part of pre-market approval requirements, the Government of Korea requires testing reports on safety and efficacy. In addition to medical device approvals, companies need to negotiate pricing terms with the Korean Health Insurance Review and Assessment Service (HIRA).
Current issues facing the medical device industry in South Korea include reimbursement pricing governed by the National Health Insurance (NHI), the new healthcare technology assessment system for medical devices, and the recently passed regulation requiring devices to be registered every 5 years, which takes effect in 2025.   
With the implementation of the KORUS FTA, U.S. medical device and pharmaceutical companies can now request a review of government pricing and maximum reimbursement determinations for its products through an Independent Review Process. Established to regulate medical devices and drug prices, this review process is independent of the Ministry of Health and Welfare (MoHW), the National Health Insurance Service (NHIS), and the Health Insurance Review and Assessment Service (HIRA). 

U.S. medical device manufacturers should follow Korean government pricing and reimbursement policies as the country grapples with cost containment under its national healthcare system.

Opportunities

An opportunity to highlight the potential for U.S. companies is via clinical trials in Korea. South Korea is interested in developing a more robust clinical trial environment for medical devices and pharmaceuticals. U.S. companies that require clinical trials for their medical devices and are interested in accessing Korea’s excellent hospital networks and physicians can contact the Medical Device Policy Division of the Ministry of Food and Drug Safety through their local importer.   
According to the Report on the Prospect of Advanced Medical Devices by MFDS (Ministry of Food and Drug Safety), another opportunity to consider is the emerging market of Artificial Intelligence-based (AI) medical device software.
The market size for AI-based medical device software was approximately $41 million in 2018 and approximately $55.5 million in 2019, with an annual average growth rate of nearly 45 percent. It is expected to record approximately $244.5 million in 2023.

Resources

Trade Shows
Korea International Medical and Hospital Equipment Show 2021:
http://www.kimes.kr/eng/
March 18 - 21, 2021 / COEX, SEOUL KOREA

Key Contacts
Ministry of Health and Welfare (MoHW) – www.mw.go.kr
Ministry of Food and Drug Safety (MFDS) –  www.mfds.go.kr
Health Insurance Review and Assessment Service (HIRA) -  www.hira.or.kr  
National Evidence-based Healthcare Collaborating Agency (NECA):  http://neca.re.kr/eng/  

Local Contact
Mr. Joonho Yoon
Commercial Specialist
U.S. Commercial Service, Korea
U.S. Embassy Seoul
188 Sejong-daero, Jongno-gu
Seoul 03141, Korea
Tel:  82-2-397-4439
E-mail:  Joonho.Yoon@trade.gov
http://www.export.gov/southkorea