In addition to empowering medical device manufacturers to send UDI data with the seamless submission capabilities of CXH, Syndigo is here to help you keep a pulse on the industry. Reference the list below.
*Please note these dates are ever-evolving. This list is based on the best information available to Syndigo and has been updated as of September 29, 2021.
FDA (GUDID)
U.S.
Class 1 Devices: Sept 2022
NMPA (CFDA)
China
Class III Devices: Mar 2022
Class II Devices: Jan 2024
Class 1 Devices: Jan 2026
SFDA
Saudi Arabia
Class D Devices: Aug 2022
Class B&C Devices: Feb 2023 (estimated)
Class A Devices: Feb 2024 (estimated)
MFDS
South Korea
Devices, Pharma
Class II Devices: July 2021
Class 1 Devices: July 2022
EC
Europe
UDI & Device Registration
Voluntary Submissions begin Oct 2021
Estimated Compliance begins Q4 2023*
*Information based on recent European Commission Rolling Implementation Plan
SMDR
Singapore
Devices
Implantables: Nov 2022
Class D: Nov 2024
Class C: Nov 2026
Class B: Nov 2028
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