A list of recently updated articles regarding medical device regulatory updates from the TGA and other governing bodies in Australia.

TGA Emphasizes Medical Device Distribution Record-Keeping

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On May 23rd, 2024, the Therapeutic Goods Administration (TGA) updated its distribution records page for medical devices.

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TGA Updates Rules for Medical Device Manufacturers

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On June 14th, 2024, the TGA made some amendments (2024 Measures No.2) to Australia’s medical device regulations.

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Australia Issues New Guidance on AIMD and MLMD

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On May 9th, 2024, Australia’s Therapeutic Goods Administration (TGA) updated its guidance for AI Medical Devices and Machine Learning Medical Devices.

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Australia’s SaMD Regulatory Deadline

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Beginning on November 1st, 2024, Australia’s Therapeutic Goods Administration will implement new rules surrounding software as a medical device (SaMD). While some SaMD will require additional regulatory requirements, other SaMD will be exempted from some, or excluded completely, from the new regulations.

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Medical Device Advertising Requirements in Asia

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In addition to receiving market authorization for the safety and efficacy of their product, manufacturers wishing to advertise their medical devices, especially Direct to Consumer, may need to also obtain approval for their marketing material.

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Asia Actual is the Best Medical Device Consulting Company in Asia

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Manufacturers looking to Southeast Asia to help grow their medical device sales will need to become familiar with the Common Submission Dossier Template, or “CSDT.”

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Australia’s TGA Continues Alignment with EU Regulations

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the TGA made significant changes concerning software, spinal implants, personalized devices, drug administering products, and companion diagnostics that affect many medical device manufacturers. Additionally, the Active Implantable Devices (AIMD) classification will be absorbed into Class III as of November 25, 2021.

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