Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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47 result(s) found, displaying 26 to 47
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GuidanceThis guidance describes the requirements for manufacturers and sponsors of faecal microbial transplant (FMT) products in TGO 105.
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GuidanceGuidance for sponsors of COVID-19 IVDs about their ongoing obligations
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GuidanceGuidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13.
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GuidanceHow to meet regulatory requirements for the manufacture and supply of menstrual cups in Australia.
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GuidanceGuidance for sponsors and manufacturers about pathways for exporting a ventilator from Australia.
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GuidanceGuidance to help manufacturers of active medical devices, including software-based medical devices, to classify their devices.
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GuidanceGuidance on mandatory requirements and ongoing responsibilities for all manufacturers and sponsors of medical devices.
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GuidanceGuidance for manufacturers and sponsors on the product standards that apply to haematopoietic progenitor cells (HPCs).
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance 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).
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GuidanceGuidance on our risk-based approach and criteria for autologous human cell and tissue exemptions, exclusions and regulation.
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GuidanceGuidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.
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GuidanceGuidance for manufacturers to assist them with managing 3D printing risks and meeting the Australian regulatory requirements for medical devices.
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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
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GuidanceGuidance on preliminary assessment requirements for medical devices, including in-vitro diagnostics (IVDs), being included in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
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GuidanceFind out how TGA regulates software and artificial intelligence (AI) based medical devices.
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GuidanceGuidance about regulatory changes for software based medical devices, including software as a medical device (SaMD).
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GuidanceGuidance for interpreting the Pharmaceutical Inspection Co-operation Scheme (PIC/S) guide to good manufacturing practice (GMP) for medicinal products.
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GuidanceGuidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.
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GuidanceGuidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.
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GuidanceGuidance for manufacturers in the development of Technical Master Files (TMF) relevant to blood, blood components and haematopoietic progenitor cells.