KTC to Participate in the 20th Gangwon Medical Equipment Exhibition… Showcasing Comprehensive Medical Device Testing and Certification Services
- Supporting domestic companies in obtaining overseas certification for medical devices through a global network
▲ KTC Promotional Booth
The Korea Testing Certification Institute (KTC) announced on the 4th that it will participate in the ‘20th Gangwon Medical Equipment Exhibition (GMES 2024)’ held at the Wonju Medical Device Comprehensive Support Center in Gangwon from September 5th to 6th.
Established in 1969, KTC is a testing and certification body and the first specialized institution designated by the Ministry of Food and Drug Safety to provide testing and certification services in the domestic medical device sector. Through this exhibition, KTC plans to showcase various testing and certification services to visitors, including ▲ guidance on the medical device approval process, ▲ consultations on overseas certification for medical devices in Europe, Japan, China, etc., and ▲ updates on the latest MDR certification trends.
To establish a global certification support system for domestic medical device companies, KTC has signed agreements with testing and certification bodies in Japan, China, and other countries, beginning with its collaboration with ECM. Recently, an agreement with China’s GRG TEST allows for testing within Korea without sending samples abroad, thereby reducing costs and shortening the certification acquisition period for domestic companies.
Furthermore, KTC plans to assist Korean companies in leading the market by registering as a designated testing laboratory for MDR/IVDR CE certification through an agreement with 3EC in Slovakia (scheduled for September). This agreement will enable KTC test reports to be recognized when acquiring MDR/IVDR CE certification, following the new regulations that replaced the former MDD (Medical Device Directive) and IVDD (In Vitro Diagnostic Medical Device Directive).
- MDR (Medical Devices Regulation): A reinforced medical device management system of the European Union (EU) that ensures safety, efficacy, and traceability throughout the entire lifecycle of medical devices.
- IVDR (In Vitro Diagnostic Medical Devices Regulation): A management system for in vitro diagnostic medical devices, similar to MDR.
- ECM (Ente Certificazione Macchine srl): An internationally accredited testing organization headquartered in Italy, designated as a certification body for quality management systems, IECEE NCB, and Machinery in international and European markets.
- GRG TEST: Guangdian Metrology and Measurement Group (China's designated testing body for medical devices by NMPA).
KTC President An Seong-il stated, “The medical device industry is advancing with the integration of the latest technologies and the sophistication of AI convergence. KTC will continue to make its best efforts to support domestic medical device companies with testing and certification services based on our extensive experience and know-how.”
Meanwhile, ‘GMES 2024’, hosted by Gangwon Special Self-Governing Province and Wonju City, aims to support the global market expansion of Gangwon's medical device companies and directly contribute to increased exports. The event will feature 134 companies, 149 booths, and over 100 overseas buyers, along with various side events such as export consultations and tailored consulting linked with public institutions. More information can be found at the exhibition or on the Wonju Medical Device Techno Valley website.
Links: 19th Gangwon Medical Equipment Exhibition, Wonju Medical Device Techno Valley
