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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

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This Regulation Impact Statement (RIS) has been prepared by the Therapeutic Goods Administration (TGA). The purpose is to assist Australian Government decision making on how to address the problems that have been identified in relation to the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations) of in vitro diagnostic medical devices (IVDs) under the new (since July 2010) regulatory framework, particularly in relation to difficulties some members of the sector anticipate in achieving compliance with the new requirements.

A number of proposals to address the identified issues are examined in this RIS including the previously unanticipated negative impact on consumers, laboratories, industry and bodies or individuals associated with the IVD sector if no action is taken to resolve the problems.

This RIS details the problems associated with the framework adopted in July 2010 and summarises the consultation process that has been undertaken with stakeholders to determine the best way forward. The RIS concludes with recommended proposals, including an outline of proposed amendments to the new framework for Government consideration.

Several minor typographical and editing errors in the Regulations were also identified during the consultation process. The TGA does not consider that these changes substantially alter the existing arrangements and no additional costs will be incurred by business or not-for-profit organisations with amendments to correct these in conjunction with the other proposed amendments.

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