medicines-medical devices-regulatory affairs
The TGA. Australia has provided further information on the reclassification of of software based medical devices. Recent changes to regulation of software based medical devices The regulatory changes came into effect on 25 February 2021 as previously reported in this…
Post last updated on 5 July 2021. The TGA, Australia has created a hub on the Unique Device Identification (UDI) system for medical devices. The hub brings together information about the Australian Unique Device Identification (UDI) system under the following…
The TGA has published Version 1.0 of the Australian electronic submissions basics guide. The guide is entitled Australian electronic submission basics eCTD and NeeS Basics Who is the guide for? It is for users who are new to the TGA’s…
The TGA, Australia has updated its guidance on the Declaration of Conformity (DoC) procedures for certain Class I medical devices. The guidance was originally published in December 2020. It has now been updated to Version 1.1 to include Class I…
The TGA, Australia has issued guidance on GMP compliance requirements and framework for managing GMP compliance signals. The 17 page guidance document outlines: the Good Manufacturing Practice (GMP) compliance requirements according to the Manufacturing Principles for manufacturing biologicals and medicines…
The TGA, Australia has published an update on the registration or variation of Category 1 and Comparable Overseas Regulator (COR) report-based prescription medicines. Module 1.2.1: Application form This application form must be used for the following Category 1 and COR…
The TGA has renamed the Clinical Trial Exemption (CTX) scheme to the Clinical Trial Approval (CTA) scheme. The change more accurately reflects the nature of the scheme under the Therapeutic Goods Act 1989, which involves sponsors applying for the TGA’s…