Bringing a Medical Device to Korea: A Practical Guide to Approval, Reimbursement and Distribution

Korea is a sizable and import-friendly market for medical devices. In 2025, the domestic market reached KRW 11.9 trillion (about US$8.4 billion), up 12.6%, and imports supplied 60.3% of it. Korea imported US$5.04 billion of medical devices, and US$2.40 billion, or 47.7%, came from the United States, more than from any other country.

Getting a device to Korean patients, however, involves several institutions working on separate timelines: the Ministry of Food and Drug Safety (MFDS) for market authorization, the Health Insurance Review and Assessment Service (HIRA) and the Ministry of Health and Welfare (MOHW) for reimbursement, and hospitals and distributors for sales. This guide brings together official statistics, the current rules and practical points for foreign manufacturers planning their entry.

1. Read the market numbers

According to MFDS, Korea produced KRW 12.4 trillion of medical devices in 2025 and exported US$5.37 billion, so the market is not only an import market. Korean makers are strong in categories such as dental implants and ultrasound imaging. Imports, on the other hand, are spread widely. The ten largest imported items, including disposable electrosurgical electrodes, soft contact lenses, CT and MRI systems, dialysis filters, drug-eluting stents and surgical robots, together make up only 18.1% of imports.

The US is followed by Germany (15.0%), Japan (7.1%) and China (5.7%) as sources of imports. The US Commercial Service notes that US companies face price competition from lower-cost products in consumables and mid-range devices, while high-tech devices with no direct competitor have strong potential. It also notes that hospital demand slowed during the trainee doctors' walkout from February 2024 to September 2025, and expects moderate growth in 2026.

2. Start with the device class

Korea classifies medical devices into four classes by intended use and potential risk, in a system MFDS describes as harmonized with international (GHTF/IMDRF) rules. The class determines the pathway:

Class 1 devices are notified to the National Institute of Medical Device Safety Information (NIDS). Most Class 2 devices are certified by NIDS after an MFDS-designated body reviews the technical documents. Class 3 and 4 devices, and some Class 2 devices such as those requiring clinical data, need MFDS approval.

Most imported products take the lighter routes. Of the 3,823 filings for imported products in 2025, 75.6% were Class 1 notifications, 19.7% Class 2 and 4.7% Class 3 or 4. For approvals, the official application form sets a statutory processing period of 65 days where technical documents are reviewed and 80 days where clinical data are reviewed. These clocks stop while the applicant responds to requests for additional information, so elapsed time is usually longer.

Licenses are valid for five years and must be renewed. In September 2026, the government also proposed rule changes that would consolidate the Class 2 review and certification steps at NIDS. These are a proposal, not yet in force.

3. Decide who holds the license

A foreign manufacturer cannot hold a Korean device license directly. The Korean importer holds an import business license and the product licenses, and the US Commercial Service advises that foreign companies need a local importer or representative with an address in Korea to handle regulatory compliance and pre-market approval.

This makes the choice of license holder a business decision as well as a regulatory one. If the license sits with a distributor and the relationship changes later, the product's registration is tied to that partner. A common approach is to keep the license with a Korean subsidiary or an independent license-holding representative, separate from the commercial distributor. Procedures for changing the license holder should be confirmed with MFDS or a regulatory specialist before signing distribution agreements.

4. Prepare for the quality system audit (KGMP)

Before a license is granted, the manufacturer's quality management system must conform to Korea's manufacturing and quality management standard (KGMP). Conformity certificates are valid for three years, and MFDS has the authority to inspect overseas manufacturing sites.

For companies already in the Medical Device Single Audit Program (MDSAP), there is a practical option. Since December 19, 2023, MDSAP audit reports can be used for a desktop review in place of an on-site KGMP audit for initial, additional and change audits, according to regulatory consultancy summaries of the MFDS notice; renewal audits remain on-site. This applies to the quality system audit only. We are not aware of a general route by which an FDA clearance or CE marking replaces the Korean product review.

5. Reimbursement: a separate clock

Korea has a single national health insurer, so for most hospital products, reimbursement shapes demand as much as approval does. After the MFDS license, the steps typically run as follows:

HIRA checks whether the device or procedure is already covered, within 30 days (extendable once by 30 days). If the technology is new, it goes through a new health technology assessment, which MOHW decides with the support of the National Evidence-based Healthcare Collaborating Agency (NECA). The result is due within 250 days, or 140 days for diagnostic and genetic tests. For a treatment material, the coverage application is filed within 30 days of the license, and the coverage and price decision is due within 100 days.

The government describes the full sequential path as taking up to 490 days. Some materials are listed with their own ceiling price, while others are treated as part of a procedure fee. A product can also be sold as non-reimbursed, paid by the patient. According to the US Commercial Service, pricing looks at the prices of similar products, and higher reimbursement requires evidence of long-term cost-effectiveness.

6. Faster routes for innovative devices

Korea has introduced several routes to shorten this path.

Innovative medical device designation, available since 2020, offers priority and staged review. MFDS has designated 133 devices, 45 of them in 2025, and 62 designated products have reached approval. Designation assesses innovation and feasibility; safety and efficacy are still reviewed at approval.

Since October 2022, designated innovative devices in areas such as AI and digital health can have MFDS review, the HIRA coverage check and NECA's assessment run in parallel rather than in sequence.

Since January 26, 2026, the "market immediate-entry" scheme has allowed devices on a published list of 199 items, mostly digital devices and in vitro diagnostic reagents, plus robotic surgical systems and powered exoskeletons, to be used clinically as non-reimbursed for up to three years before the new health technology assessment, if they meet set conditions. The government estimates that entry time can fall from up to 490 days to as little as 80 days. The scheme is new, and its effect in practice is not yet known; views also differ on the balance between faster access and pre-market evaluation.

Digital devices have their own framework. The Digital Medical Products Act took effect in January 2025, cybersecurity is a required review item, and MFDS issued guidelines for generative AI medical devices in January 2025. In 2025, MFDS approved or certified 153 AI-based devices, 34 of them imported.

7. Distribution and hospitals

Most foreign manufacturers sell through local distributors. The US Commercial Service recommends one reliable exclusive distributor, or a master distributor with regional sub-dealers, rather than several overlapping partners. Demand for high-end equipment is concentrated in general and university hospitals. Korea currently has 47 designated tertiary hospitals, and the next designation results are expected in December 2026. Many hospitals buy treatment materials through purchasing agents, which is another link to understand in the supply chain.

8. After launch: ongoing compliance

Compliance continues after the first sale. Labels must be in Korean and carry the license holder, country of manufacture and a unique device identifier (UDI). Suppliers report monthly what they supplied, to whom and in what quantity, through MFDS's integrated system, including unit prices for supplies to medical institutions. Advertising in specified media needs prior review by a self-regulatory body, and licenses must be renewed every five years.

On trade, the Korea–US Free Trade Agreement (KORUS), in force since 2012, provided for Korean tariffs on US medical equipment to be eliminated within ten years, and the US Commercial Service reports that most qualifying devices now enter duty-free, subject to rules of origin.

For meeting partners, KIMES, Korea's main medical device trade show, is scheduled for March 18–21, 2027 at COEX in Seoul, according to the US Commercial Service.

What this means for foreign device companies: a practical checklist

Confirm your class first. It determines the pathway, the documents and the timeline.

Choose the license holder deliberately. Decide whether the license sits with a subsidiary, an independent representative or your distributor before you sign.

Use your MDSAP report. If you have one, it can replace many on-site KGMP audits with a desktop review.

Plan reimbursement early. Map the MFDS, HIRA and NECA steps in one plan, and check whether innovative device designation or the immediate-entry list applies.

Bring cost evidence. Comparator prices and cost-effectiveness data matter, especially for premium products.

Pick one distributor. Clear territory, targets and terms make the relationship easier to manage.

Prepare for life after launch. Budget for Korean labeling, UDI, monthly supply reporting, advertising review and five-year renewals.

The bottom line

Korea's device market relies on imports and on US products in particular, but entry depends on two separate processes, approval and reimbursement, and on choosing the right local partners. Companies that plan both clocks together, and decide early who holds their license, avoid the most common delays.

GlobalRika works in Seoul with foreign healthcare and technology companies entering Korea: helping them understand the path to market, find and meet distributors, hospitals and corporate partners, and prepare materials in Korean. If you are looking at the Korean market, we would be glad to talk. Contact us at info@globalrika.com.

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About the data

Market figures are from MFDS's 2025 production, export and import results, published in May 2026, converted at the 2025 average rate of KRW 1,421.97 per US dollar. Filing figures are from MFDS's 2025 approval report (April 2026). Statutory periods are from the Medical Device Act enforcement rule forms and the national health insurance and new health technology assessment rules in force in October 2026; actual timelines vary. This article is general information, not regulatory or legal advice. Requirements change, so confirm details with MFDS, HIRA or a qualified regulatory specialist.

Sources

• Ministry of Food and Drug Safety, 2025 medical device production, export and import results (May 28, 2026)

• Ministry of Food and Drug Safety, 2025 approval trends for drugs, quasi-drugs and medical devices (April 30, 2026); innovative medical device designations in 2025 (January 29, 2026); AI medical device cybersecurity (May 27, 2026)

• Ministry of Food and Drug Safety, English regulatory overview; Medical Device Act and enforcement rule, application form No. 3

• Medical Times, proposed Class 2 review changes (September 17, 2026) and five-year license renewal (February 3, 2026)

• Emergo by UL, MFDS acceptance of MDSAP reports (March 2024)

• Rules on National Health Insurance benefit standards (in force April 15, 2026); Rules on new health technology assessment (in force January 26, 2026)

• Shin & Kim, market immediate-entry medical technology (February 11, 2026); Money Today (January 26, 2026); Medifonews, integrated review for innovative devices (2022)

• MFDS presentation to IMDRF on the Digital Medical Products Act (March 2025); Shin & Kim, generative AI medical device guideline (2025)

• US International Trade Administration, South Korea Country Commercial Guide: Medical Equipment and Devices; Healthcare Resource Guide: South Korea; South Korea medical devices market intelligence (December 3, 2025)

• USTR, KORUS FTA pharmaceutical and medical device provisions

• Medical Times and Money Today, tertiary hospital designation (2026); Dailypharm and Kukinews, medical device supply reporting (2019, 2022)