The official signing ceremony for the Memorandum of Understanding (MoU) with the Korea Total Healthcare Ecosystem Association (KOTHEA) was held on May 15, 2026, at the Ente Certificazione Macchine (ECM) headquarters in Valsamoggia (Bologna). The agreement marks the beginning of a collaboration aimed at facilitating access for Korean companies to the European medical device market.

A BRIDGE TO EUROPE FOR DIGITAL HEALTHCARE

The core objective of this partnership is to support Korean digital companies—particularly those focused on Software as a Medical Device (SaMD) and Artificial Intelligence (AI)-based diagnostic solutions—through the process of obtaining CE certification under the MDR regulation.

The agreement outlines four key areas of cooperation:

• Industrial Networking: Promoting business opportunities between Korean manufacturers and the ECM network.

• Information Exchange: Continuous updates on European regulatory requirements.

• Certification Support: Creating direct channels to reduce uncertainty for manufacturers.

• Capacity Building: Organizing educational seminars and workshops.

ROLES AND RESPONSABILITIES

Under the terms of the agreement, KOTHEA will act as a liaison, selecting top-tier companies from the Korean digital healthcare sector and ensuring they submit the necessary information in compliance with global standards and certification requirements. ECM, for its part, will provide its technical expertise to guarantee efficient and fair conformity assessments.

A CEREMONY OF INTERNATIONAL PRESTIGE

The event was attended by a high-profile panel of international authorities and guests – including the Consul General of the Republic of Korea in Milan, Choi Taeho; the top leadership of KOTHEA, with President Kijoon Shim, Secretary General Heekyung Jung, and Director General of Global Expansion Projects Seongjun Lim; the President of the Emilia-Romagna Regional Assembly, Maurizio Fabbri; Gianluca Baldoni (Emilia-Romagna Region – Attractiveness, Internationalization, and Research Department); Metropolitan Delegate Councillor Paolo Crescimbeni; and the Mayor of Valsamoggia, Milena Zanna, along with Deputy Mayor Federica Govoni – who highlighted the strategic relevance of the agreement and the central role of the Emilia region in the global biomedical landscape.

The day concluded with a fruitful networking session aimed at fostering direct dialogue among corporate delegations, institutional representatives, and industry professionals, officially laying the groundwork for future technological and commercial developments in the field of digital health.

STAY TUNED!

In the coming weeks, we will publish further content related to this extraordinary event and the evolution of this new international collaboration.