medicines-medical devices-regulatory affairs
Last updated on: 24 November 2021. See update at the end of the post. TGA, Australia is consulting on the remaking of some TGOs and other legislative instruments for human cell and tissue (HCT) products. What are Therapeutic Good Orders…
The TGA, Australia has provided an update on its GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic. The update concerns certain temporary measures introduced in 2020 for overseas manufacturers. The following items are addressed: On-going…
The TGA, Australia has implemented a Data Protection Scheme for assessed listed medicines and published guidance to facilitate the scheme. What is the scope of the guidance? The guidance provides: an overview of the Data Protection Scheme for Assessed Listed…
TGA, Australia has published guidance on the imminent reclassification of certain medical devices. Which medical devices are going to be reclassified? The following medical devices are going to be reclassified: Medical devices in direct contact with the heart, central circulatory…
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…
The TGA, Australia has published guidance for developers and users of software to decide which software and apps are medical devices. The flowcharts in the guidance document show which software products are regulated as a medical device and which are…
The TGA is consulting on proposed refinements to the regulation of medical devices that are substances introduced into the human body via an orifice or applied to the skin. Events leading to this consultation In early 2019, the TGA conducted…
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 summarised for sponsors, the changes to the process for the inclusion of certain medical devices and IVD medical devices in the ARTG. For which devices has the the process for inclusion in the ARTG changed? The…