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.
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 Updates Guidance on the Use of Comparable Overseas Regulatory Assessments for Medical Devices
The Australian TGA updated its guidance on the use of overseas regulatory assessments for medical devices, including recognition of UK MHRA approved bodies. Learn what this means for manufacturers seeking ARTG inclusion.
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.
TGA atualiza orientações sobre software de apoio à decisão clínica
A TGA publicou novas orientações sobre o software de apoio à decisão clínica (Clinical Decision Support Software – CDSS), clarificando quando este tipo de software é considerado um dispositivo médico e quando pode beneficiar de isenção de inclusão no ARTG. O documento visa apoiar fabricantes, promotores e desenvolvedores na conformidade com os requisitos regulamentares e na avaliação do risco associado a soluções digitais de saúde.
TGA Australia updates guidance on regulatory requirements for companion diagnostics (CDx)
Australia's TGA has published a new version of its regulatory guidance for IVD companion diagnostics (CDx), with a direct impact on medical device manufacturers and sponsors of drugs and biologics. The document describes the legal framework, clinical and analytical assessment criteria, classification, ARTG submission requirements and the use of in-house developed CDx.