Guidance

Understand the regulatory requirements for supplying UDI compliant medical devices in Australia

Timeframes for supplying UDI compliant medical devices in Australia

This guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.

Guidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.

Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

Manufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).

This guidance is to assist you to apply for a Certificate of Free Sale or an Export Certificate for medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs).

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).

Information to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.

Guidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.

Guidance for sponsors on the process for including IVD medical devices in the ARTG.

Guidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).

Guidance detailing self-certification procedures for Class I non-measuring, non-sterile non-IVD medical devices; Class 1 IVD medical devices; some systems and procedure packs; medical devices for export.

Guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.

Guidance for sponsors of COVID-19 IVDs about their ongoing obligations

Guidance for sponsors and manufacturers about pathways for exporting a ventilator from Australia.

Guidance clarifying the interaction between our requirements and AHPRA advertising guidelines.

Guidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.

Guidance for new sponsors on how to supply, import, and export disinfectant products.

Guidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.

Guidance on the format requirements for dossiers.

Guidance to assist sponsors and manufacturers when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG) and selecting a GMDN term.

Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.