KTC Selected for Software Medical Device Manufacturer Quality Management Technology Support Project
Customized technical support for companies... Project to invest a total budget of 400 million KRW by the end of November
Workforce capacity building education and quality management standard model also established... "Contributing to securing competitiveness"
▲ KTC Gunpo Headquarters Panorama
The Korea Testing Certification Institute (KTC, President: Seong-Il Ahn) announced on the 19th that it has been selected for the Ministry of Food and Drug Safety's 'Customized Quality Management (GMP) Technology Support Project for Software Medical Device (SaMD) Manufacturers.'
Software as a Medical Device (SaMD): Intangible medical devices such as AI and medical applications.
GMP (Good Manufacturing Practice): Regulations for the manufacture and quality management of pharmaceuticals, established by the WHO.
This project, jointly promoted with the Korea Smart Healthcare Association (SHA), will be implemented over a total of eight months until November 30th, with a total budget of 400 million KRW.
The project includes:
Technical support for SaMD manufacturers
Establishing a standard model for quality management
Providing capacity-building education for company employees
Forming and operating an expert consultative group
According to the 2022 survey by the Ministry of Food and Drug Safety, the domestic production of SaMD increased more than 20 times, from 1.49 million KRW in 2021 to 30.47 million KRW in 2022. Additionally, SaMD exports increased approximately 60 times, from 195,600 USD to 11.8473 million USD.
However, SaMD manufacturers face challenges such as shorter design and development periods compared to general medical devices, and frequent product changes, making GMP approval difficult.
The Ministry of Food and Drug Safety anticipates an increase in demand for SaMD permits due to the paradigm shift caused by digital transformation (DX) across the industry after COVID-19.
KTC plans to provide basic and international quality management system (QMS) education to strengthen the capabilities of manufacturers and offer customized technical support. Additionally, an internal and external GMP expert consultative group will be formed and operated, and a standard model based on real case studies will be developed by investigating the quality management status of domestic and international SaMD.
KTC expects that this project will enhance the quality management level of domestic SaMD manufacturers and accelerate the overseas market entry of export companies.
Seong-Il Ahn, President of KTC, stated, "This will be an opportunity to contribute to securing the competitiveness of domestic companies by quickly responding to the rapidly changing digital industrial environment and advancing the quality management system. We will continue to support companies and strive to protect the safety and health of the public."
