MISSION-DRIVEN
Local Authorized Representative
The import representation service is an essential element for foreign medical device manufacturers to meet the regulatory requirements of specific countries and smoothly launch their products in the market. In particular, communication with regulatory authorities plays a crucial role, from product approval to post-market management, and a trusted local representative in Korea is needed to fulfill this role.
The import representative acts as a bridge between the manufacturer and the regulatory authorities, handling tasks such as document submission, regulatory compliance review, and supporting the approval process. After market launch, they also manage product-related filings and post-market surveillance, efficiently handling all regulatory requirements.
Through this service, manufacturers can save time and resources, overcome the complexities of local regulations, and launch their products more effectively. The local representative is a key partner that helps manufacturers build trust in the market by ensuring compliance with local laws and minimizing legal risks.
