Tag Archive for: SaMDs

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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Asia Actual Summit in Indonesia

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April 23rd to 27th, 2024, Asia Actual Indonesia hosts Asia Actual USA, Singapore, China, Vietnam, Philippines, and Thailand, for a Summit.

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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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LAUNCHING AI DEVICES AND SOFTWARE AS MEDICAL DEVICES IN THAILAND

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The novel characteristics of AI software and Software as Medical Devices (SaMDs) are stressing bureaucratic regulatory, customs and taxation systems around the world. Thailand is no exception.

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CHINA: REGULATORY AND COMMERCIAL UPDATES

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The NMPA has been highly active in 2020 updating many of their regulations, standards and processes. If you’re considering entering the Chinese market, please contact us to identify how some of the new changes could affect your time and costs. Asia Actual Can Help Navigate the Evolving Regulatory Process in China

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