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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.
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.
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.”
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.