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What's new
95 result(s) found, displaying 26 to 50
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PageInternational standards can support safety, quality and cyber security in medical device software.
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Market actionsEdgewell Personal Care Australia Pty Ltd is recalling all unexpired batches (nine in total) due to the potential for the lotions to become separated.
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PageWe are reviewing all ventilators, continuous positive airway pressure (CPAP), and bi-level positive airway pressure (BiPAP) devices in the ARTG.
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PageWe have identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway.
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PageWe are reviewing all ventilator, CPAP, and BiPAP devices in the ARTG to clarify what devices incorporate sound abatement features.
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PageFind out more about our post-market review of ventilator, CPAP and BiPAP devices included in the Australian Register of Therapeutic Goods (ARTG).
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Market actionsGem Care Products Pty Ltd is recalling all unexpired batches (two in total) due to the potential for the lotions to become separated.
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Australian public assessment report (AusPar)Augtyro has been approved for the treatment of adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).
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Advertising permissionApproval under section 42DF for use of restricted representations by B Braun Australia Pty Ltd
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PageFind the monographs available for over-the-counter (OTC) new medicine N2 applications.
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Media releasesTGA has issued infringement notices to Prime Medic Group Pty Ltd (Prime Medic) and an individual for the alleged unlawful advertising of weight loss medicines in contravention of the Therapeutic Goods Act 1989 (the Act).
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Advertising permissionApproval under section 42DF for use of restricted representations by Stryker Australia Pty Ltd
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PageThe Poisons Standard consists of decisions regarding the classification of medicines and poisons into Schedules for inclusion in the relevant legislation of the States and Territories.
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News articlesThe Adverse Event Management System (AEMS) has moved to the cloud, delivering improved system stability and security.
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PageKey information about the shortage for patients, carers and health care professionals
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PageTo help sponsors understand and meet their ongoing regulatory obligations after consent to supply is granted and throughout the consent period.
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GuidanceThis guidance is to assist entities and individuals planning to export medicines (including prescription, over-the-counter (OTC) and complementary medicines) either for commercial supply, or for non-commercial purposes (for example, for a family member or friend).
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PageTo help sponsors apply for permission to import, supply, or export medical devices that do not fully comply with one or more Essential Principles for a limited period.
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PageInformation on when software is classified as an in-vitro medical device and how it is regulated.
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GuidanceHow to confirm that your OTC application is an N1 application and how to compile the information and assurances for N1 applications.
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PageWhat consumers should know when using software-based medical devices.
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PageThings health professionals should know when using software-based medical devices.
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Advertising permissionThis instrument is made under section 42DK of the Therapeutic Goods Act 1989