KTC to Host ISO 10993 Seminar to Strengthen the Capabilities of Korea’s Medical Device Industry
The Korean Testing Certification Institute will host the “ISO 10993-1, 17, and 18 Seminar” on September 11 at the main auditorium of the Korea Medical Devices Industry Association in Gangnam-gu, Seoul.
The event is intended for employees of Korean medical device manufacturers, regulatory affairs professionals, and other industry stakeholders.
The seminar aims to share the latest international standards and regulatory developments concerning the biological evaluation of medical devices and strengthen the industry’s practical response capabilities.
It will focus on ISO 10993-1, which provides the overall framework for biological evaluation; ISO 10993-17, which addresses toxicological risk assessment; and ISO 10993-18, which specifies the chemical characterization of medical device materials.
The event will begin at 2 p.m. on September 11.
Professor Sang-bae Lee of Yonsei University College of Dentistry will present the biological evaluation process for medical devices and the latest developments in ISO 10993-1 and ISO 10993-18.
Geon-hee Kim of the Korean Testing Certification Institute will explain regulatory requirements and practical approaches to the chemical characterization of medical devices.
Se-gyeong Kim, a researcher at the Ministry of Food and Drug Safety, will introduce the latest developments in ISO 10993-1 and their impact on Biological Evaluation Reports.
Tae-won Kim, Center Director at the Korean Testing Certification Institute, will present the procedures and practical cases for conducting Toxicological Risk Assessments based on ISO 10993-17:2023.
A question-and-answer session with participants will follow the presentations.
Those wishing to attend may register through the QR code on the seminar poster published on the Korean Testing Certification Institute’s website.
The Korean Testing Certification Institute has continuously organized seminars on medical device testing, certification, and overseas certification support to help Korean companies resolve regulatory approval challenges and enter global markets.
While previous seminars focused on full-cycle regulatory approval processes, overseas certification trends, and practical information, this event will provide more specialized and in-depth guidance on the principal international standards for biological evaluation.
Toxicological risk assessment and chemical characterization are becoming increasingly important in medical device safety evaluations. The industry must also respond effectively to revisions to international standards.
The seminar is expected to help companies establish systematic evaluation strategies from the early stages of product development and strengthen their capabilities for Korean and international regulatory approvals.
President Sung-il Ahn of the Korean Testing Certification Institute emphasized that ensuring the safety and reliability of medical devices is essential to protecting public health and strengthening the competitiveness of Korea’s medical device industry.
He stated that the Institute would continue supporting Korean medical device companies in responding effectively to changes in international standards and establishing a stronger foundation for global market entry through its accumulated testing and certification capabilities and field-oriented technical support.
