Guidance

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

This guidance helps sponsors and manufacturers of ‘unapproved’ therapeutic vapes understand quality and safety requirements, under the Therapeutic Goods (Medical Device Standard —Therapeutic Vaping Devices) Amendment Order 2024.

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

Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13.

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

How to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.

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 to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.

Guidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).

Guidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.

Guidance on the documents that may be required to include a medical device in the Australian Register of Therapeutic Goods (ARTG), including In Vitro Diagnostic medical devices (IVDs).

Guidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).

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 about regulatory changes for software based medical devices, including software as a medical device (SaMD).

Guidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.

Guidance on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients.

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

Guidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.

Guidance for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.