“Understanding Regulations Is the First Step to Exporting”: Wonju Medical Device Industry Promotion Agency Holds Seminar on Overseas Expansion

【Financial News, Wonju = Reporter Kim Gi-seop】Support measures to expand domestic medical device companies’ export opportunities—from solutions for overcoming stringent U.S. and European certification barriers to a platform connecting them with 30,000 overseas buyer records—were introduced at a medical device exhibition in Busan.
According to the Wonju Medical Device Industry Promotion Agency on the 23rd, it held two seminars that day to support overseas regulatory approvals and entry into global markets at the 14th Busan International Medical Equipment Exhibition (KIMES BUSAN 2026), held at BEXCO.
In the morning, it held the KIMES BUSAN Overseas Certification Seminar with the Korea Medical Devices Industry Cooperative. Participating companies shared strategies for responding to overseas regulations they must navigate in the export process, including the U.S. Food and Drug Administration (FDA)’s Quality Management System Regulation (QMSR) and certifications from the International Organization for Standardization (ISO).
The seminar was organized as part of the Medical Device International Certification Support Center project, supported by the Ministry of Health and Welfare and overseen by the Korea Health Industry Development Institute. The agency has been responsible for the project from June 2022 through December this year, supporting the provision of overseas certification information, consultations and consulting, and training specialists in regulatory approvals. It also provides overseas certification information through an online platform dedicated to the project and operates a training academy.
The K-Medical Industry Global Market Entry Support Seminar, held in the afternoon, covered the European Medical Device Regulation (MDR) and strategies for addressing clinical evaluations. It also introduced ways to prepare for audits under the Medical Device Single Audit Program (MDSAP), along with commonly cited cases of nonconformity.
At the seminar, the agency also presented the main features of G2M, a global market information and buyer-matching platform, and how to use it. By 2028, the agency plans to add 30,000 records of overseas buyer information, along with market trends in 30 countries, to the platform, and to enhance its AI-based market information analysis and buyer-matching functions.
The afternoon seminar was part of the K-Medical Industry Global Market Entry Support Platform Establishment Project, into which the Ministry of Trade, Industry and Energy is investing a total of 23.2 billion won from 2024 to 2028. Participants in the project include the agency, the Korea Trade-Investment Promotion Agency (KOTRA), the Korea Medical Devices Industry Cooperative, and the Yonsei University Industry-Academic Cooperation Foundation.
Kim Young-sung, head of the Wonju Medical Device Industry Promotion Agency, said, “Accurately understanding the different certification standards in each country, such as the FDA’s quality management regulations and the European Medical Device Regulation, is the starting point for entering overseas markets.” The agency head added, “Through support that extends from certification consultations and training specialists in regulatory approvals to identifying buyers using G2M, we will help domestic companies take their place on a broader export stage.”

[email protected] Kim Gi-seop Reporter