Category TGA (Australia)

TGA publishes guidance on the imminent reclassification of certain medical devices

TGA, Australia has published guidance on the imminent reclassification of certain medical devices. Which medical devices are going to be reclassified? The following medical devices are going to be reclassified: Medical devices in direct contact with the heart, central circulatory…

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TGA publishes guidance for developers and users of software to decide which software and apps are medical devices

The TGA, Australia has published guidance for developers and users of software to decide which software and apps are medical devices. The flowcharts in the guidance document show which software products are regulated as a medical device and which are…

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TGA consults on proposed refinements to regulation of substances (medical devices) introduced into the human body or applied to the skin

The TGA is consulting on proposed refinements to the regulation of medical devices that are substances introduced into the human body via an orifice or applied to the skin. Events leading to this consultation In early 2019, the TGA conducted…

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Changes to the TGA process for the inclusion Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG

The TGA, Australia has summarised for sponsors, the changes to the process for the inclusion of certain medical devices and IVD medical devices in the ARTG. For which devices has the the process for inclusion in the ARTG changed? The…

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TGA consults on proposed refinements to regulation of personalised medical devices

The TGA, Australia, is consulting on proposed refinements to the regulation of personalised medical devices. On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are…

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