Navigating Medical Device Regulations: U.S. and South Korea Market Entry Strategies

Event Details

The U.S. and South Korea are both major players in the global medical device industry, offering lucrative opportunities for companies seeking international expansion. Understanding the regulatory landscapes of both countries is crucial for companies aiming to enter and succeed in these markets.

Led by AGG Food & Drug chair Alan Minsk and Barun Law attorneys Eun-jin Jang and Grace Koh, this webinar provides comprehensive perspectives on medical device market entry — guiding U.S. companies through South Korea’s regulatory frameworks, while also offering insights for Korean companies looking to expand into the U.S. from an FDA perspective. The session will also cover approval pathways, FDA-compliance requirements, and strategic considerations for navigating both markets.

Key Topics Covered:

• South Korean and U.S. medical device regulatory overview
• Considerations for successful market entry, including recommendations to maximize success and minimize risk

Key Takeaways:

• A dual-market perspective on regulatory and compliance requirements in both South Korea and the U.S.
• Practical strategies for obtaining approvals and market access
• A roadmap for successfully expanding medical device businesses across both markets

Credits: 1 hour of CLE credit is pending approval by the State Bar of Georgia

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Register

The webinar will be held on two dates:

April 29, 2025 | 12-1 p.m. Eastern Daylight Time
(April 30, 2025 | 1-2 a.m. Korean Standard Time)
Click Here to Register

April 30, 2025 | 12-1 p.m. Korean Standard Time
(April 29, 2025 | 11 p.m. – 12 a.m. Eastern Daylight Time)
Click Here to Register