The Korean Testing Certification Institute (KTC) announced on the 21st that it has been selected for four projects in the customized regulatory science technology development sector of the ‘2026 Pan-Ministerial Advanced Medical Device R&D Project’ led by the Pan-Ministerial Medical Device R&D Project Group.
KTC has plans to become a partner in end-to-end technology and regulatory support for the medical device industry through the execution of these projects.
The selected projects include: ① Establishment of a technology support system for securing Rapport and development of evaluation technology for software-based medical devices, ② Customized establishment and technical support for an automatic verification system for digital medical device software reliability and security quality gates, ③ Development of regulatory science-based evaluation technology for rapid product realization of advanced diagnostic medical devices and support for licensing, and ④ Advancement of evaluation technology for blood-based residual specimen stability and establishment of an integrated regulatory science support system for all TRL stages of in vitro diagnostic medical devices.
KTC will form a consortium with relevant organizations and execute these four projects from this year until 2032. Through this, KTC will establish a technical support foundation spanning the entire cycle—such as product planning, development, performance evaluation, testing and inspection, clinical trials, licensing, and commercialization—for AI convergence medical devices and advanced/in vitro diagnostic medical devices. This aims to strengthen the technological capabilities of domestic medical device companies and support their entry into the global market.
Due to the diverse technological structures and operating methods of advanced medical devices integrating software (S/W) and hardware (H/W), there are cases where newly developed products do not fit product codes, classifications, or related regulations. As a result, domestic medical device companies are facing many difficulties during product launch processes, such as establishing licensing strategies and responding to regulations.
To resolve these challenges, KTC will conduct: the establishment of the Rapport-based technology support system and development of evaluation technology for software-based medical devices (worth KRW 5.4 billion each), as well as customized establishment and technical support for an automatic verification system for reliability and security quality gates in digital medical device software.
Additionally, KRW 5.4 billion will be invested in developing regulatory science-based evaluation technologies and supporting licensing for expedited product realization of advanced diagnostic medical devices. Furthermore, with a budget of KRW 4.05 billion, KTC will conduct advancement of blood-based residual specimen stability evaluation technologies and establish an integrated regulatory science support system for all TRL stages of in vitro diagnostic medical devices.
President Sung-il Ahn of KTC stated, “KTC will enhance companies’ regulatory response capabilities and establish domestic and overseas licensing support systems, thereby contributing to the global competitiveness of domestic medical device companies.”
