Webinar: Medical Device Regulations in South Korea
Join us in a discussion about South Korea’s medical device regulations and registration processes with our guest speaker Yoojin Ahn, a leading regulatory affairs and quality assurance expert based in Anyang-si, South Korea.
Priya Bhutani introduces a webinar discussing new medical device regulations in South Korea set to take effect later this year, specifically impacting global compliance. The company RegDesk offers a machine-learning platform for regulatory requirements, alerts, and expert advice.
Yoojin Ahn, a regulatory expert from South Korea, highlights three key changes:
1. Labeling Requirements: Manufacturers must include a record number on products, akin to a unique device identification.
2. Electronic Instructions for Use (IFU): Complex devices can provide IFUs on their websites rather than printed copies.
3. Reclassification of Products: About 2,515 products will be re-evaluated for their classification, which may change based on safety and risk factors.
Yoojin explains the timeline for compliance:
Class 4 devices must comply by July 2019.
Class 3 by 2020, Class 2 by 2021, and Class 1 by 2022.
All manufacturers, regardless of device class, will need to adapt to these changes. The discussion also covers local testing requirements, clinical data acceptance from foreign studies, and the importance of preparation for these regulatory updates.
Attendees are encouraged to engage during the Q&A session at the end of the webinar.