KTC Participates in the Gangwon Medical Equipment Show 2023
Korea Testing Certification institute (KTC) has confirmed its participation in Gangwon Medical Equipment Show (GMES 2023), scheduled to take place from September 21st to 22nd at the Medical Device Complex Center(MCC) in Wonju, Gangwon Province.
KTC, a specialized organization offering comprehensive testing and certification services in the domestic medical device sector, aims to provide attendees with valuable insights during the exhibition. This includes guidance on the ▲medical device regulatory approval process ▲consultation regarding overseas medical device certifications in Europe and Japan ▲a diverse range of testing and certification services in the field of biohealth.
Furthermore, KTC will present its 13 Strategic Fields, with a focus on digital and green transformation, designed to empower domestic enterprises to lead the market and align with evolving paradigms in future industries.
On the 22nd, within the exhibition premises, KTC will conduct a seminar featuring experts from Cosmos Corporation, a Japanese certification body, titled "Japanese Medical Device Certification Agency Seminar." This seminar, a part of the business agreement signed with Cosmos Corporation in July, aims to provide information on ▲technical documentation and quality management system evaluation for Japanese medical devices ▲trends in Japanese medical device certification.
KTC has been actively building networks with testing and certification bodies in Japan and Europe, as the scale of medical device exports to these regions has been increasing. Starting with the collaboration with Cosmos Corporation, KTC was registered as the first domestic testing and certification body for medical devices by the European Medical Device Regulation (MDR) certification body ECM in September.
As a result, KTC is poised to facilitate seamless exports of Korean medical devices to Europe, particularly in light of the MDR, initially scheduled for implementation in May 2024 but delayed twice due to insufficient preparation time for certification bodies and the industry. Some high-risk devices have now been granted conditional extensions until the end of 2027, while medium and low-risk devices have extensions until the end of 2028.
President Sungil Ahn of KTC, commented on this development, stating, "The medical device industry is not only a promising growth sector but also a nationally significant industry with prospects for sustained growth." He further added, "We are committed to bolstering our support for testing and certification services, contributing not only to the advancement of the domestic medical device industry but also to an increase in medical device exports."
In the meantime, "GMES 2023," organized by Gangwon Province and Wonju City, aims to enhance the export capabilities of Gangwon's medical device companies. The event features various supplementary programs, including an invitation-only meeting with over 180 overseas buyers and consultations with public agencies.
