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.

Apply for Membership

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

KAMDA members work through each of them in the U.S. and share what they have learned with Korean companies coming next.

FDA Clearance

Regulatory strategy, submissions and approval case studies.
Reimbursement

How a cleared device gets paid for in the U.S. insurance system.
Lab Route (CLIA and LDT)

Offering a test through a CLIA-certified U.S. laboratory.
Partners and Acquisitions

Buying or partnering with a U.S. company to reach the market.
Risk, IP and Compliance

Contracts, liability and intellectual property once you sell here.

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.