KAMDA, Korean American Medical Devices Association
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501(c)(3) nonprofit · founded March 11, 2025

Korean device makers, entering the U.S. together

Founded by six Korean-American device and diagnostics companies already operating here, KAMDA shares what U.S. entry takes: FDA clearance, reimbursement, lab routes, partners.

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About twenty KAMDA founding members and guests posed in two rows at Access Bio Inc., New Jersey.
Founding meeting, Access Bio Inc., New Jersey. March 11, 2025.

Five barriers on the road to U.S. customers

The 2025 conference was built around them, in this order. Each had its own session, led by people who work on it in the U.S.

  1. FDA clearance

    Regulatory strategy, submissions and approval case studies.

    • Session FDA Trends & Global Regulation Insights Haja Sittana El Mubarak, Ph.D., Wasela Diagnostics
    • Session FDA Approval Strategies and Success Cases ByungSik Chang, Ph.D., Nano-Ditech
    • Session FDA Preparation and Approval Strategy (CRO) JungYoup Han, Ph.D., Target Health

  2. Reimbursement

    How a cleared device gets paid for in the U.S. insurance system.

    • Session Understanding the U.S. Healthcare Insurance System (Reimbursement system) MinSoo Seo, Taewoong Medical USA

  3. Lab route (CLIA and LDT)

    Offering a test through a CLIA-certified U.S. laboratory.

    • Session Market Entry Strategy for the U.S. (Applications of LDT and CLIA Lab) JungHee Cho, Ph.D., LabG USA

  4. Partners and acquisitions

    Buying or partnering with a U.S. company to reach the market.

    • Session Market Entry Strategy for the U.S. (Case Studies of U.S. Local Company Acquisitions) Curie Choi, Immunostics

  5. Risk, IP and compliance

    Contracts, liability and intellectual property once you sell here.

    • Session Appropriate Risk Allocation in the FDA World Sung Park, Reed Smith
    • Session Understanding IP and Compliance Eunjean Je, Morgan, Lewis & Bockius

October 23, 2025 · Reed Smith LLP, New York

The 1st KAMDA Conference

“Facing the Real Barriers: Korean Medical Device Companies' Strategic Entry into the U.S.”

  1. 9:30 AMRegistration and networking
  2. 10:30 AMWelcome and congratulatory remarks: Consulate General of Korea in New York, KHIDI, KOSME, Korea Venture Investment Corp.
  3. 11:00 AMOpening plenary and keynote: MARA Nanotech, Access Bio
  4. 1:00 PMSession I: Strategies and FDA Considerations for U.S. Market Entry
  5. 2:50 PMSession II: U.S. Market Entry Strategy and Insights
  6. 5:30 PMPanel: U.S. Market Entry and Medical Device Market Strategy
  7. 6:40 PMDinner and networking
Download the 2025 program Full program and speakers
KAMDA leadership in discussion around a conference table at the Consulate General of Korea in New York, with the Korean flag behind them.
Consulate General of the Republic of Korea in New York. June 11, 2025.

Working with Korea's institutions in the U.S.

  • Consulate General of the Republic of Korea in New YorkLeadership meetings with Consul General Kim Ui-hwan on April 22 and June 11, 2025; congratulatory remarks at the 2025 conference.
  • Korea Health Industry Development Institute (KHIDI)Boston office at the founding and the 2025 conference; KHIDI USA announced the conference.
  • Korea SMEs and Startups Agency (KOSME)New York Global Business Center at the founding and the 2025 conference.
  • Korea Venture Investment Corp.New York office gave a congratulatory remark at the 2025 conference.
  • Korea IVD association (KIVDA)Circulated the 2025 conference notice to its members.

Membership

Two ways to join

Applications are reviewed by KAMDA. Payment instructions are sent after review.

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Founded on March 11, 2025 by

Supported the 2025 conference

  • Consulate General of the Republic of Korea in New York
  • KOSME (Korea SMEs and Startups Agency)
  • KHIDI (Korea Health Industry Development Institute)
  • Reed Smith
  • Bank of Hope

Covered by

The 2026 conference date has not been announced

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