AABB Signs MOU With Korea Testing and Research Institute

Last week, AABB signed a landmark memorandum of understanding (MOU) with leaders from the Korea Testing and Research Institute (KTR), part of the South Korean Ministry of Industry. Under the terms of the MOU, KTR and AABB are pledging to “foster economic growth in the fields of testing and certification” and to support advancements “in the fields of in vitro diagnostics and laboratory support equipment.” 

The MOU sets the stage for critical collaboration and potential future projects between AABB and KTR. Of note, AABB will now serve as the primary third-party reviewer for KTR’s submission of eligible medical devices as part of the FDA’s 510(k) process. This will allow for a more streamlined submission and approval process and will assist in the timely review and approval of medical devices   so that they can receive marketing clearance for the United States sooner.   

AABB is proud to be part of this historic initiative and welcomes the opportunity to work with colleagues in South Korea on advancing the blood and biotherapies field. AABB was pleased to participate in a signing ceremony last week with leaders from KTR, including Kim Hyun Cheol, president of KTR; Kim Jin Tai, KTR’s general director of global business; Jeong Chang Seok, KTR’s director of global cooperation; and Kim Tae Gun, KTR’s director secretary. At the ceremony, AABB was represented by Debra BenAvram, CEO; Michael Grogan, COO; Christine Bales, vice president of consulting and global services; and Melanie Sloan, senior director of accreditation and quality. 

“AABB is honored to collaborate with KTR to support Korean medical device manufacturers seeking to enter the U.S. market,” BenAvram said. “This new partnership will help to ensure the quality and safety of new products used in the treatment of patients and will help to further advance the blood and biotherapies field in both the United States and South Korea.” 

The new partnership between AABB and KTR was part of a larger initiative that advanced the partnership between the United States and South Korea last week, culminating in the State Visit at the White House honoring South Korean President Yoon Suk Yeol and celebrating the 70th anniversary of the alliance between the two nations. According to information from the White House, President Biden and President Yoon “reaffirmed their ironclad commitment to what has become a global alliance focused on deepening defense and security ties, expanding economic, commercial, and environmental cooperation, increasing digital and technology collaboration—including in the space sector—and broadening development assistance, educational exchanges, and people-to-people ties.”