Global UDI Deadlines by Region/Regulator

Stay up to date on UDI deadlines set by various regulatory bodies around the world

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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