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Regulation impact statement: Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)

Version 1.0, October 2014 - OBPR Reference: 14631

17 October 2014

Book pagination

This Regulation Impact Statement (RIS) examines a number of issues that were identified during the initial stages of the transition period of the new regulatory framework for IVD medical devices (IVDs), and was prepared by the Therapeutic Goods Administration (TGA). The RIS assists Australian Government decision making in addressing the concerns raised in the consultation process particularly in relation to difficulties some members of the sector anticipated in achieving compliance with the new regulatory framework. The RIS concludes with an outline of proposed amendments to the new framework to reduce regulatory burden for the IVD sector.

Version history

Version Description of change Author Effective date

Original publication

Certified by Office of Best Practice Regulation (ref 14631)

Office of Devices Authorisation 17/10/2014

Book pagination