Australia Updates Guidance on UDI Compliance Timeframes for Medical Devices
The TGA has updated its guidance on UDI compliance timeframes for medical devices in Australia, including clarifications on legacy devices, EU MDR transitions, consignment stock, and Surgical Loan Kits.
TGA Introduces Streamlined UDI Consent-to-Supply Pathway for Non-Compliant Medical Devices
Australia’s TGA has released new guidance on streamlined UDI Consent-to-Supply applications for medical devices that do not meet UDI-related Essential Principles. Learn how the changes affect manufacturers, ARTG entries, timelines, fees, and compliance strategies.