Tag Archive for: deadline

China Releases New List of Standards for Medical Device Registration

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The NMPA has released the 2024 revised edition of the “List of Mandatory Standards Applicable to Medical Device Products.

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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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China’s Third Batch of UDI Implementation Deadline in June

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Reminder that China NMPA’s UDI implementation deadline is June 1st, 2024 after which all aforementioned devices must be labelled.

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China Continues to Implement UDI of Medical Devices with Third Batch Release

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The NMPA Continues UDI Implementation in China with Third Batch Release announced February 17, 2023 including 103 types of Class II medical devices.

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