ITA CODE: PR MED
Overview
Medical Device Market Size
(Units: $ millions)
| 2019 | 2020 | 2021 | 2022 |
Total Local Production | 6,244 | 8,589 | 11,257 | 12,186 |
Total Exports | 3,710 | 6,637 | 8,629 | 7,878 |
Total Imports | 4,160 | 4,430 | 5,353 | 4,890 |
Imports from the US | 1,939 | 1,894 | 2,214 | 2,241 |
Total Market Size | 6,694 | 6,382 | 7,981 | 9,198 |
Source: Ministry of Food and Drug Safety
Since the outbreak of COVID-19 in 2020, there have been substantial changes in the Korean medical device market. Before the pandemic, Korea was an import-driven country for medical devices but became an export- driven country in 2020 due to the surge in the export of diagnostic kits for COVID-19. Additionally, the value of medical device imports rose by 20 percent in 2021, contributing to the record-breaking expansion of the domestic medical device market. U.S. medical devices are ranked first in the Korean import market, with market share steadily maintained between 40 to 50 percent. Korea’s imports of Chinese-made medical devices increased between 2020 and 2021 from $346 million to $658 million, increasing its market share from 7.8 percent in 2020 to 12.3 percent in 2021. The leading item imported from China in 2021 was specimen collection tools valued at $407 million, a market that China dominates with a 99 percent market share in Korea. However, the demand for such tools peaked in 2021 and fell dramatically in 2022 as Korea passed the peak of the pandemic. As a result, Chinese medical devices saw their market share in Korea decline to 7.9 percent in 2022 at $386 million. While total imports decreased from $5.4 billion in 2021 to $4.9 billion in 2022, the total Korean medical device market grew from $8.0 billion in 2021 to $9.2 billion in 2022 as domestic products gained market share.
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 the Korean government’s pricing and reimbursement policies as the country grapples with cost containment for its national healthcare system.
The import of medical devices requires the assignment of an importer or representative based in South Korea to manage medical device approvals and 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 must 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 Service (NHIS), a new healthcare technology assessment system for medical devices, and a new regulation requiring devices to be registered every five years, which takes effect in 2025.
As stipulated under the KORUS FTA, U.S. medical device and pharmaceutical companies can request a review of government pricing and maximum reimbursement determinations for their 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
In general, Korea is a prime destination for U.S. medical device companies manufacturing high-end medical devices. Korean companies make comparatively lower-end or mid-range medical devices, therefore depend on the United States, Europe, and Japan to supply high-end medical devices. China, on the other hand, supplies low-end medical devices and economical consumables in Korea, so U.S. companies cannot compete with Korean and Chinese companies in mid-range to low-end segments because of high prices.
As Korea becomes a leading exporter of medical devices, the Korean government is also trying to support domestic medical device companies interested in expanding to the global market. In June 2023, President Yoon Suk-Yeol highlighted ways to export more Korean biotechnologies to the global market at the Fifth Export Strategy Meeting. As Korean companies look to sell to the international markets, there are business opportunities for U.S. healthcare consulting firms to help Korean companies with clinical research, product registration, medical device licensing, and market access.
Unlike other advanced economies, doctor-to-patient telehealth service is banned in Korea. During the COVID-19 pandemic, doctor-to-patient telehealth services had been temporarily allowed to minimize the spread of infections, but this ended on May 31, 2023. The full legalization of telemedicine is unlikely in the short term due to stakeholder and political opposition. However, more industry experts are recognizing the benefits of telemedicine and agree that it is an irreversible trend worldwide. In response, the Korean government launched a telemedicine pilot program in June 2023 exclusively for second-visit patients who suffer from infectious diseases or reside on remote islands, older adults who cannot visit health facilities, and people with disabilities. The adoption of telemedicine in Korea could represent new opportunities for the U.S. medical device industry in the next few years.
Resources
Trade Shows
Korean International Medical & Hospital Equipment Show (KIMES)
https://kimes.kr/eng/
March 14~17, 2023
COEX Hall A, B, C, D
BIO Korea International Convention
https://www.biokorea.org/index.asp?pLn=Eng
May 10~12, 2023
COEX Hall C
K-Hospital Fair
https://en.khospital.org/
Sep 14~16, 2023
COEX Hall C, D
Key Contacts
· Ministry of Health and Welfare (MoHW) - https://www.mohw.go.kr/eng/
· Ministry of Food and Drug Safety (MFDS) - https://www.mfds.go.kr/eng/index.do
· National Health Insurance Service (NHIS) - https://www.nhis.or.kr/english/index.do
· Health Insurance Review and Assessment Service (HIRA) - https://www.hira.or.kr/eng/main.do
· National Evidence-based Healthcare Collaborating Agency (NECA) - https://www.neca.re.kr/eng/index.do
· Korea Medical Devices Industry Association (KMDIA) - https://www.kmdia.or.kr
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