Regulatory compliance for IVD medical devices

29 June 2015

On 30 June 2015 the transition period for all commercial IVD medical devices will cease. Sponsors must ensure their IVD medical devices meet the requirements of the IVD regulatory framework and have submitted an effective application for inclusion in the Australian Register of Therapeutic Goods.

The TGA actively monitors the quality, safety and performance of all therapeutic goods when they become available to consumers to ensure the on-going compliance of the products with TGA’s regulatory requirements. The TGA also actively monitors unlawfully supplied products and takes appropriate regulatory action where these are identified. Any non-compliance activities from 1 July 2015 that are related to commercial IVD medical devices will be addressed through the TGA Regulatory Compliance Framework.