KTC and Hyundai Meditec Co., Ltd. join hands to support companies in the medical device and biotech healthcare industries.
The Korea Testing Certification (KTC) and Hyundai Meditec Co., Ltd. (hereinafter referred to as Hyundai Meditec) announced on the 19th that they have signed a business agreement to strengthen technical collaboration in the medical device and biotech healthcare industries and establish a smooth collaborative system.
The purpose of this agreement is to facilitate the development of a foundation for technical competitiveness in the medical device and biotech healthcare fields and to expand into international markets through technological collaboration between the two institutions. The institutions have agreed to collaborate on △information exchange for technological advancement in medical devices and biotech healthcare △prioritized commissioning and support for testing services △research and development of new technologies and products.
As of 2021, the global medical device industry has a market size of $454.2 billion, showing an annual growth rate of over 5%. The emergence of various technologies, especially medical software, is expected to lead to the expansion of personalized diagnosis, treatment, and prevention, contributing to the global market growth.
However, domestic medical device companies are facing challenges due to stringent regulations throughout the product lifecycle, from product development to clinical trials and post-market surveillance, in response to the changes in the European Medical Devices Regulation (MDR*).
MDR (Medical Devices Regulation): An enhanced medical device management system in the European Union (EU) that enables verification of safety, effectiveness, and traceability throughout the entire lifecycle of medical devices.
KTC, designated as the testing and inspection organization for the largest number of item categories by the Ministry of Food and Drug Safety, and also recognized as a Good Manufacturing Practice (GMP) inspection organization, provides comprehensive testing and certification services. Additionally, through business agreements with the European MDR certification body ECM* and others, KTC supports rapid entry into the European market for Korean companies.
ECM (Ente Certificazione Macchine srl): An internationally accredited testing organization based in Italy, operating as a certification body for quality management systems, IECEE NCB, and machinery sectors in international and European certification.
President An Sung-il of KTC stated, "We will spare no effort in combining KTC's testing and certification services with Hyundai Meditec's new technologies to enhance competitiveness in the medical device and biotech healthcare industries and lead industrial development."
