ITA CODE:  PR MED 

Overview 

(Total market size = (total local production + imports) - exports) 
Units: $ millions 
Source: MFDS (Ministry of Food and Drug Safety) 

Since the outbreak of COVID-19 in 2020, there are a few important changes in the landscape of Korean medical device market.  

According to the Ministry of Food and Drug Safety (MFDS), the amount of import rose at 20 percent in 2021, contributing the record-breaking expansion of size for the medical device market in Korea. The US medical device has been ranked in the first place over the past four years in the Korean import market, with its market share steadily maintained between 40 to 50 percent.  

In recent years. however, the share of Chinese medical device grew rapidly. Its share in the medical device import market increased from 7.8 percent in 2020 to 12.3 percent in 2021. China entered the third place with a narrow margin behind Germany, which decreased from 17.4 percent in 2020 to 14.8 percent in 2021.  

The total production and export amount by local manufacturers in 2021 also increased over 30 percent, recording $11.3 billion and $ 8.6 billion in USD respectively. The MFDS views this increase was brought by the surge in the export of diagnostic kits for COVID-19 in 2021.  

The total market size for medical device in Korea unprecedentedly decreased with -3.5 percent growth rate in 2020. However, Korea recovered from its impact relatively in a fast manner and its total market size reached the record-breaking amount of $7.9 billion in USD in 2021. 

Sub-Sector Best Prospects 

• Multifocal intraocular lens.
• Charged-particle accelerator for therapy.
• Soft contact lenses.
• Hemofilter for artificial kidney.
• Coronary artery stent.
• CT systems.
• MRI devices.
• Disposable dialyzer.
• Reagents for clinical Immunochemistry.
• Internal knee prosthesis.
• Sight corrective ophthalmic lenses.

Regulatory Environment   

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

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 Ministry of Food and Drug Safety (MFDS) 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 Korea include reimbursement pricing governed by the National Health Insurance (NHI), the new healthcare technology assessment system for medical devices, and the new 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).   

Opportunities 

Unlike other advanced economies in the world, doctor-to-patient tele-health service is banned in Korea. Despite this market challenge, there are recently some positive signs that the door to tele-health service in Korea may open in the future.  

Since the outbreak of COVID-19 in 2020, the doctor-to-patient tele-health services have been temporarily allowed to support those who wish to minimize the exposure of in-person medical treatment. This temporary measure has allowed Korean patients to see first-hand the benefit of tele-health service. Experts believe this will provide momentum to Korean government’s efforts to convince the major opponents, including the Korean Medical Association, of the long-term value of telemedicine.  

In addition, Korean government has moved to deregulate tele-health services by designating a regulation-free special zone in Wonju city (70 miles from Seoul). Since 2021, the Korean government is allowing tele-health services for patients who have difficulties accessing regular medical services.  

Korean government has attempted to amend the existing law for the past several years. Currently only tele-monitoring medical device is allowed for sales since it does not involve doctor-to-patient medical treatment process. 

Resources 

Trade Shows 

• Korea International Medical & Hospital Equipment Show (KIMES).
• BIO Korea International Convention.
• Korea Hospital Fair.

 Key Contacts  

• Ministry of Health and Welfare (MoHW).
• Ministry of Food and Drug Safety (MFDS).
• Health Insurance Review and Assessment Service (HIRA).
• Korea Medical Devices Industry Association (KMDIA).
• National Evidence-based Healthcare Collaborating Agency (NECA).

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