UDI Implementation – What is required ?
July 11, 2018 - Online Event ON CAWebinar Compliance
info@webinarcompliance.com
Phone:416-915-4438/ 58
The US FDA has published the final regulations for Unique Device Identification (UDI). Manufacturers must start implementation planning. UDI implementation requires understanding of several major steps: Producing compliant device labels, packaging Uploading the appropriate information into the GUIDID Updating affected work instructions and/or standard operating The UDI regulations include changes: Part 803 (Medical Device Reporting) Part 806 (Medical Devices; Reports of Corrections and Removals) Part 814 (Pre market Approval of Medical Devices) Part 820 (Quality System Regulation) Part 821 (Medical Device Tracking Requirements) Part 822 (Post market Surveillance)