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Australia releases overview of proposed IVD regulations

This article was originally published in RAJ Devices

Executive Summary

Australia’s Therapeutic Goods Administration has published an overview of the proposed new regulatory framework for in vitro diagnostic devices that it intends to introduce later this year1. Prior to the implementation of the new IVD framework, however, the Therapeutic Goods (Medical Devices) Regulations 2002 will have to be amended to include provision for IVDs. The TGA says that the regulations are currently being redrafted and when they are available, it will be organising information sessions for stakeholders.




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