Australia’s new device requirements come into effect

The Australian Therapeutic Goods Agency (TGA) has made significant changes to some of its regulations, including those governing software-based medical devices. The TGA has said that entities that reclassify their products can continue to offer them for six months after 1 November 2024 if they have an application lodged with the TGA, but only if the sponsor has notified the agency of their intention to do so before 25 May 2022.

BioWorld MedTech Control Asia and Pacific Australia