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 Updates Guidance on Selection Criteria for Medical Device Application Audits
The TGA has updated its guidance on how medical device applications are selected for audit before inclusion in the ARTG, including mandatory audits, non-mandatory audit criteria, regulatory reforms, UDI and post-market signals.
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.
TGA Introduces Australia's UDI System with Phased Implementation Through 2029
The TGA has introduced Australia's Unique Device Identification (UDI) system with a phased implementation through 2029. Learn about the implementation timeline, AusUDID requirements, and what medical device and IVD manufacturers need to prepare.
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 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.
TGA Updates PRAC Guidance: What Sponsors and Manufacturers Need to Know in 2026
The TGA updated its PRAC recall procedure in February 2026. Here’s what medical device and medicine manufacturers must know about compliance and market actions 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 publica lista de verificação para implementação do sistema UDI na Austrália
A TGA publicou uma lista de verificação para apoiar fabricantes e promotores na implementação do sistema de Identificação Única de Dispositivos (UDI) na Austrália. O documento detalha os passos necessários para cumprir os novos requisitos de rastreabilidade, rotulagem e submissão de dados à base de dados AusUDID, reforçando a segurança e a transparência no setor dos dispositivos médicos.
TGA atualiza orientações para reporte de incidentes adversos com dispositivos médicos
A Therapeutic Goods Administration (TGA) publicou uma versão atualizada do guia sobre reporte de incidentes adversos com dispositivos médicos. O documento reforça as responsabilidades de fabricantes, patrocinadores e profissionais de saúde, estabelecendo prazos rigorosos para a comunicação de eventos adversos, com o objetivo de fortalecer a vigilância pós-comercialização e proteger a segurança dos pacientes.