KTC Enters Strategic Partnership with Hans Biomed Co., Ltd.
KTC Enters Strategic Partnership with Hans Biomed Co., Ltd.
▲ Photo from the Business Agreement Signing Ceremony
(Left: President Sungil Ahn of KTC, Right: CEO Guen Young Kim of Hans Biomed Co., Ltd.)
Korea Testing Certification institute (KTC) and Hans Biomed Co., Ltd. are pleased to announce their recent collaboration, marked by the signing of a strategic agreement on October 5. This partnership aims to bolster technological cooperation within the bio-health and medical device sectors and establish a seamless operational framework for mutual benefit.
The agreement was established with the goal of enhancing technological competitiveness in the bio-health and medical device industries through collaborative efforts. Both entities have committed to mutual information exchange to foster technological advancements, prioritize testing services, and actively support research and development in the fields of bio-health and medical devices.
In 2021, the global medical device industry was valued at $45.42 billion and has been experiencing an annual growth rate of over 5%. The advent of diverse technologies, particularly in medical software, is poised to expand personalized diagnosis, treatment, and prevention capabilities, contributing to the industry's global expansion.
Despite these promising prospects, domestic medical device companies encounter challenges due to stringent regulations that encompass the entire product life cycle – from product development and clinical trials to post-market surveillance. These regulations have become more stringent following the changes in the European Union's Medical Devices Regulation (MDR).
KTC, recognized as the testing and inspection agency with the most extensive range of items by the Ministry of Food and Drug Safety, also serves as the inspection agency for medical device manufacturing and adheres to quality management standards (GMP). To facilitate the global expansion of Korean companies, KTC recently entered into a partnership with the European MDR certification body, Ente Certificazione Macchine srl (ECM), in September. This collaboration streamlines European certification processes through the acceptance of KTC's test reports and the registration of MDR assessors.
Sungil Ahn, President of KTC, expressed, "By amalgamating KTC's exceptional testing and certification services with Hans Biomed's cutting-edge technologies, we endeavor to enhance competitiveness in the bio-health and medical device sectors, actively contributing to the advancement of our industries."
