Are UDI requirements in South Korea similar to other health regulators?
The short answer is ‘not exactly’. In this episode of Reed Tech Insights, we discuss the legislation, policy, timing and data attributes involved in the South Korean Unique Device Identification (UDI) system. South Korea’s Ministry of Food and Drug Safety has set up a system to help track the reporting of adverse events related to medical devices and introduced UDI requirements for implementation starting in 2019 for high-risk devices.
For basic information for South Korea’s MFDS compliance rules, fill in the form below to download a convenient UDI checklist.
Listen to the short video below for the latest update on current deadlines. Also, learn about expected timing for UDI reporting and requirements for on-label by class and Track & Trace requirements.
5:30 min duration
Navigating the complexities of regulatory requirements for UDI for the US FDA or other global health authorities can quickly become a burden.
For more information, contact us at MedDevice@ReedTech.com or call +1-215-557-3010