Consultation on proposed changes to labelling of medicines supplied in Australia

Medicine labels give health professionals and consumers important information to help use medicines safely and correctly. If labels are hard to read or understand, medication errors are more likely. Medicines prescribed or given by a health professional have different risks and need...

Closes today

Public Consultation - Annual Charge Exemption (ACE) Scheme Compliance Program Updates

Annual Charge Exemption Scheme The Annual Charge Exemption (ACE) scheme commenced on 1 July 2015. It provides an exemption from paying Therapeutic Goods Administration (TGA) annual charges until a therapeutic good covered by an entry on the Australian Register of Therapeutic Goods (ARTG)...

Closes 20 March 2026

Consultation: Conformity Assessment Procedures for Medical Devices | Proposed Amendments

We are aware of recent proposed changes to the European regulations. Those proposed changes will be considered with the responses to this consultation. The TGA has been systematically reviewing the way medical devices are regulated. This has been guided by An Action Plan for Medical...

Closes 31 March 2026

Personalised medical devices consumer survey

The Therapeutic Goods Administration (TGA) regulates medical devices to ensure they are safe and work as intended. We regularly review and update our rules to keep pace with technology and protect patients and consumers. We are currently reviewing personalised medical devices. These are...

Closes 24 April 2026

NOTIFICATION FORM: Clinical decision support software exemption

This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 . The exemption applies to medical devices that are clinical decision...

Closes 25 December 2031

Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR

Transitioning devices This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. Complete this form if you are a sponsor or agent seeking to...

Closes 31 July 2029

Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR

This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. This tool will assist you to determine what actions you may or may not need to take...

Closes 31 July 2029