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What's new
191 result(s) found, displaying 51 to 75
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Meeting statementsThe Advisory Committee on Medical Devices (ACMD) held its 90th meeting on 16 April 2026.
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PageThe Australian UDI Data Dictionary includes a list of the fields in the database, including element names, descriptions, permitted values and other metadata.
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PageRead the latest enhancements and fixes to the Australian UDI Database Pre-Production environment.
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PageThe list of current mesh products supplied in Australia.
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Scheduling decisions (interim)Interim decisions and invitation for comment. Closing date: 10 July 2026.
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PageFind out more about the post-market review we are undertaking on plastic syringes.
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PageResources and technical documents for Machine to Machine (M2M) HL7 SPL users in the Australian Unique Device Identification Database (AusUDID).
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Safety updatesWe have identified reports of FluMist being administered in error to children under 2 years of age.
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PageInformation about current processing times, workload, priorities, and key messages for GMP Clearance applications.
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PageInformation on requesting a pre-submission meeting with the TGA for planned Good Manufacturing Practice (GMP) Licensing, Certification and Clearance applications.
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PageLinks to information on good manufacturing practice (GMP), manufacturing inspections and manufacturer statutory declarations.
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PageFind out more information on the medicinal cannabis vaping devices that are approved in Australia.
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DatasetSearch registrations for new medicines including generic medicines, chemical and biological entities (NCE and NBE), biosimilar medicines, biologicals and combinations. This includes extensions of indications, which describes new uses of medicines.
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DatasetSearch applications for new medicines, or new uses for existing medicines, that are under current evaluation.
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Advertising permissionApproval under section 42DF for use of restricted representations by Smith & Nephew Pty Ltd
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Prescription medicine decision summaryCenrifki (tolebrutinib) has been approved for the treatment of Secondary Progressive Multiple Sclerosis (SPMS) in adults.
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Prescription medicine decision summaryTzield (teplizumab) is approved to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus.
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Safety alertsWe are advising consumers that ‘Pharmatech’ branded MK-677 capsules (containing ibutamoren) may pose a serious risk to your health and should not be taken.
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PageThe medical devices DAEN is our online database that contains information from suspected adverse events reported to us for medical devices.
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PageThe annual charge exemption (ACE) scheme is a self-declaration scheme.
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GuidanceGuidance about the Annual Charge Exemption (ACE) scheme waiver process.
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PageAll adverse events reported to us are added to this searchable database.
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Market actionsSanofi-Aventis Healthcare Pty Ltd T/A Sanofi Consumer Healthcare, is recalling the below products due to the potential presence of a glass fragment within the bottle (not within the tablets).