Guidance

This guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).

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 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 on specific criteria and paperwork required for submission to the TGA to ensure conformance with TGO 93.

Guidance on the legislative, regulatory and good clinical practice requirements when conducting clinical trials in Australia using unapproved therapeutic goods.

This guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.

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

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

Guidance on the use of market authorisation evidence from comparable overseas regulators for medical device applications.

Guidance about how to apply for a permit to export human substances under the Customs (Prohibited Exports) Regulations 1958.