Tag Archive for: deadline

Australia Issues New Guidance on AIMD and MLMD

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

Australia’s SaMD Regulatory Deadline

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.

China’s Third Batch of UDI Implementation Deadline in June

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

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

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