Articles

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

To help sponsors and manufacturers transition to new manufacturer evidence.

Transition period for accepting ISO 13485 ends 26 May 2023.

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).

The TGA has approved the first two nasal combination self-tests (for use at home) that detect both COVID-19 and influenza viral infections in humans.

On 28 March 2018, the Senate Community Affairs References Committee reported on its inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters - external site.

New legislative instrument

Invitation to the National Measurement Institute's mask/respirator testing forum.

No lasting increase in consumption following up-scheduling of low-dose products

Changes will be made to the regulation of nappy rash products on 1 January 2020

We're encouraging all Australians to return their unused opioids to their local pharmacy

Therapeutic Goods Order No. 1 of 2010.