Guidance
Our Guidance explains the laws and regulations governing the development, manufacturing, marketing, and supply of therapeutic goods in Australia.
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76 result(s) found, displaying 1 to 25
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GuidanceGuidance on the regulatory framework for in vitro diagnostic (IVD) companion diagnostics (CDx) and for the medicine or biological that requires CDx testing.
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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 describe the requirements and standards for sunscreens (and their ingredients), that we regulate as therapeutic goods in Australia
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GuidanceThis Guidance explains how overseas assessments can support our medical device certification and registration processes.
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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 sponsors who have submitted applications for inclusion of medical devices including in-vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance to help sponsors understand the potential overlap between certain foods, medicines, devices and cosmetics.
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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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GuidanceGuidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.
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GuidanceAustralian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.
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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 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).
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GuidanceThis guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.
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GuidanceGuidance for preparing a technical file review, as part of your application to include an in-vitro medical device in the Australian Register of Therapeutic Goods.
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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 to change an ARTG registered over-the-counter (OTC) medicine.
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GuidanceGuidance for manufacturers and sponsors on cyber security of medical devices that include software or electronic components.
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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 for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).
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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 about application pathways and data requirements for new generic medicines, and variations to existing medicines.
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