3-D printing (additive manufacturing) of medical devices
Posts published in “Australia”
Actual and potential harm caused by medical software
Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices
Medical device application processing times
Researcher considerations for medical devices – Meeting the evidence requirements for market authorisation
New TGA Classification Rules for Software that is a Medical Device – IMPORTANT DATES
New Australian Medical Device Regulations for Software and Personalised Medical Devices – Schedule 2 and 3
IVD companion diagnostics – Guidance on proposed regulatory requirements
Submissions received: Regulation of software, including Software as a Medical Device (SaMD)
TGA presentation: Cybersecurity for medical devices