Description: Understanding and complying with UDI requirements for a single health authority can be very difficult. In addition to learning the new UDI regulatory policies, medical device manufacturers need to evaluate various exceptions and how they apply to their product portfolio. As multiple regions (US, EU, South Korea, China, Saudi Arabia, Australia, etc.) have or will soon enforce UDI regulations, the compliance task becomes increasingly complex. Your UDI approach, implementation, and execution for a single health authority or globally is an important part of your regulatory strategy and bottom line.
This session will recap the various health authority UDI policies and timelines and encourage attendees to share their best practices in planning and meeting US, EU, and other regional UDI requirements.
Learning Objectives:
Understand the upcoming UDI compliance deadlines
Identify the four common UDI requirements across multiple health authorities
Learn practical approaches and techniques in complying with UDI