A new era of international cooperation in the digital health sector begins. During the official ceremony held at our HQ in Valsamoggia, the Korea Interministerial Healthcare Association (KOTHEA) and the European Notified Body ECM signed a crucial Memorandum of Understanding (MoU). The agreement aims to facilitate the access of Korean medical technologies into the European market.

The President of KOTHEA, Shim Ki-jun, expressed his enthusiasm through a video message, as he was unable to attend in person. In his greeting, Shim thanked the leadership of ECM for organizing an event that marks a strategic turning point for the entire global healthcare ecosystem.

OVERCOMING THE REGULATORY CHALLENGES OF CE CERTIFICATION

Europe represents the beating heart of the medical device industry, but the current regulatory landscape imposes stringent standards. In this context, the partnership with ECM proves to be strategic.

“At a time when the requirements for European CE certification are becoming increasingly complex, collaborating with an organism of the highest competence like ECM is providential news for Korean companies.” — Shim Ki-jun, KOTHEA President.

The association’s objective is to support innovative Korean digital healthcare companies in overcoming entry barriers to the EU market.

FROM THE SIGNING TO RESULTS: A GLOBAL GROWTH MODEL

In the intentions of the signatories, this MoU will not remain a mere formal promise on paper. The agreement is conceived as a solid operational bridge to transfer Korean technological excellence for the benefit of the health and quality of life of European citizens.

The next steps will involve close collaboration on the ground, led by KOTHEA’s Secretary General, Jung Hee-kyung, who attended the event in Italy. The two institutions will work synergistically to build a successful model for medical innovation and global cooperation.