The Global Gateway: Simultaneous US & Korea Launch

Challenge

A US-based cardiovascular device manufacturer wanted to enter the lucrative South Korean market but was blocked by complex local regulations, including KGMP certification, mandatory in-country testing, and the requirement for a local license holder.

Solution

Leanabl acted as the official Importer and Korea License Holder, creating a seamless regulatory bridge. We managed the on-site KGMP audit of their US facility, coordinated the required local performance testing, and handled all customs clearance and lot release activities.

Outcome

The product was successfully launched in major Seoul hospitals within 6 months of project initiation. By using Leanabl as an independent representative, the client maintained full commercial flexibility to work with multiple distributors, a strategy that ran parallel to their successful EU expansion.