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IMDRF consultation for Unique Device Identification system

The IMDRF sought comments on a proposed guidance document and two information documents.

Consultation period:
-
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This consultation closed on 12 October 2018.

The International Medical Device Regulators Forum (IMDRF) working group on a Unique Device Identification (UDI) system seeks to promote a globally harmonised approach to the application of a UDI system. This work is intended to contribute to the implementation of UDI, achieving the perceived benefits of UDI for regulators and stakeholders around the globe.

The IMDRF working group sought comments from interested parties on a proposed guidance document and two information documents on UDI.

The TGA (together with all other working group members) invited interested parties to comment on the document.

Deadline for submissions

Interested parties should respond directly to the working group chair (Mr. Salvatore Scalzo) by Friday 12 October 2018.

Do not send your responses to the TGA.

Instructions on making comments and any enquiries are included on the IMDRF website linked above.

Further information about IMDRF consultations

Further details about current (and closed) consultations, including how to make submissions, are available on the Consultations page of the IMDRF website.