AUSTRALIA: Unique Device Identification System Communications and Stakeholder Engagement – August 2022

• 2022-08-30 03:11:43

Therapeutic Goods Administration (TGA) has announced to establish an Australian Unique Device Identification (UDI) in October 2020 and has published new regulations on the approval and use of medical devices. These new regulations created a thorough database for the traceability of medical devices based on the UDI and the adverse event system.

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SINGAPORE: HSA Released Guidance on Medical Device Unique Device Identification (UDI) System – September, 2021

• 2021-08-02 04:41:50

HSA has recently released the “Guidance on the Medical Device Unique Device Identification (UDI) System”. From 2022 in transitioning phases, HSA requires medical devices to be marketed in Singapore to be equipped with UDI-DI.

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China: Submission of High Risk Medical Device with Unique Identification in eRPS System

• 2021-02-19 08:35:07

Starting from January 1, 2021, medical devices specially identified by the NMPA should register in the eRPS system, along with UDI-DI related information.

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