TGA Updates Guidance on COVID-19 Rapid Antigen Test Performance and Risk Mitigation
The TGA has updated its guidance on performance requirements and risk mitigation for COVID-19 rapid antigen tests, covering analytical and clinical evidence, self-test usability, IFU requirements, software, COR approvals and post-market monitoring.
TGA Updates Guidance on IVD Self-Tests for Chlamydia, Gonorrhoea and Syphilis
The TGA has updated its guidance on clinical performance and risk mitigation requirements for IVD self-tests for chlamydia, gonorrhoea and syphilis, including study design, usability, IFU and post-market monitoring expectations.
TGA Opens Consultation on Improving Information Sharing About Medical Devices
The TGA has opened a consultation on proposals to improve public information sharing about the safety, quality and performance of medical devices after post-market reviews or investigations.
TGA UDI Requirements for Medical Devices Commence in Australia
From 1 July 2026, certain medical devices supplied in Australia must meet TGA Unique Device Identification requirements, starting with Class IIb and Class III devices.
TGA Updates Guidance for Dental Practitioners on Personalised Medical Devices
The TGA has updated its guidance on regulatory requirements for Ahpra-registered dental practitioners making or adapting personalised medical devices for patients.
TGA Updates Guidance on Medical Device Application Audit Selection Criteria
The TGA has updated its guidance on how medical device and IVD applications are selected for audit before inclusion in the ARTG.
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.
TGA Expands Recognition of UK Approved Bodies for Medical Devices and IVDs
The Australian TGA has updated its guidance to recognise UK Approved Bodies as comparable overseas regulators, potentially simplifying ARTG submissions for medical device and IVD manufacturers.
TGA Publishes Updated Guidance on the Regulation of Software-Based Medical Devices – Key Considerations for Manufacturers
TGA publishes updated guidance on software-based medical devices. Key regulatory implications for manufacturers supplying SaMD in Australia.
Australia Updates Guidance on Export Certificates for Medical Devices: What EU Manufacturers Need to Know
The TGA has updated its guidance on Certificates of Free Sale and Export Certificates for medical devices. Key changes for EU manufacturers exporting via Australia.
TGA Updates Guidance on Varying ARTG Entries: Key Points for Medical Device and IVD Manufacturers
The TGA has released Version 6.0 of its ARTG variation guidance. Learn what manufacturers and sponsors need to know to stay compliant with ARTG requirements.