Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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28 result(s) found, displaying 1 to 25
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GuidanceUnderstand the regulatory requirements for supplying UDI compliant medical devices in Australia
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GuidanceTimeframes for supplying UDI compliant medical devices in Australia
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GuidanceThis guidance is to help sponsors and manufacturers of in-vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements.
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GuidanceGuidance for manufacturers and sponsors on shoulder, hip and knee joint replacement medical devices and ancillary medical devices.
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GuidanceManufacturers are responsible for maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles).
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GuidanceThis 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).
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GuidanceGuidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.
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GuidanceClassifying in-vitro diagnostic medical devices (IVDs) according to the health risk that may arise from an incorrect result.
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GuidanceGuidance on TGO 109: Standards for Biologicals - General and Specific Requirements.
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GuidanceGuidance for manufacturers outlining the procedures for submitting conformity assessments and declarations of conformity for in-vitro diagnostic devices (IVDs)
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GuidanceGuidance on the clinical evidence requirements for medical devices, including in-vitro diagnostic medical devices (IVDs), under Australian legislation.
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GuidanceGuidance for sponsors on the process for including IVD medical devices in the ARTG.
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GuidanceGuidance explaining how the method of preparation influences classification and whether autologous HCTs are eligible for exemptions.
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GuidanceGuidance for sponsors or suppliers of biologicals in Australia on their ongoing responsibilities after a product is included on the Australian Register. of Therapeutic Goods (ARTG).
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GuidanceGuidance explaining regulatory requirements for in-house in-vitro diagnostic medical devices (IVDs).
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GuidanceGuidance for sponsors of faecal microbiota transplant (FMT) products, which are regulated as biologicals.
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GuidanceGuidance to help determine whether products are separate and distinct biologicals that will need to be included as separate ARTG entries.
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GuidanceGuidance on TGO 107: Mandatory labelling requirements for biologicals and human cell and tissue materials.
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GuidanceGuidance to help work out if your autologous HCT product is exempt from some aspects of our regulation.
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GuidanceGuidance 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.
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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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GuidanceAustralian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.
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GuidanceGuidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.
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Applying for a Class 1 biological to be added in the Australian Register of Therapeutic Goods (ARTG)
GuidanceGuidance for preparing and submitting an application for inclusion of a Class 1 biological on the ARTG. -