TGA

Crisis management

Six uncomfortable regulatory truths in a pandemic

These are truly extraordinary times. With supply chains breaking down and demand outstripping supply for critical products such as ventilators, masks and test kits, both regulators and industry are having...
Medicine shortage

Getting Shorty – Meeting your obligations for Reporting Medicines Shortages in Australia

Ensuring adequate medicine supply to satisfy market demand is a complex business. Many products can have multinational supply chains using different suppliers of raw materials and ingredients and utilise manufacturers...
Clearing fog

TGA acceptance of international device reviews – clearing the fog

A recent discussion on the RAPS bulletin board (link here for members) revealed confusion as to what international evidence can be used to support Australian regulatory approvals for medical devices....
Door closed

The door to Europe is closed – so where else should I look?

Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
Stairs with light

The question on clients’ lips… “How long will my application take?”

Every year the TGA produce the TGA Annual Performance Statistics Report and the Half Yearly Performance Snapshot. On the 21 October 2019, The TGA released the latest annual statistics on...
Magnifying glass copy

TGA Publishes updated MDIR Guide

Last week, the Australian regulator, the Therapeutic Goods Administration (TGA) published an updated guidance for Australian Sponsors and Manufacturers for the reporting of adverse events in Australia (Medical device incident...
Business plan

TGA Regulatory Business Plan 2019-2020

The TGA Business Plan is updated annually and is a central part of their activity planning and performance monitoring framework. Late September has seen the Australian regulator, the Therapeutic Goods...
Breast implants

Breast implants and anaplastic large cell lymphoma

The TGA has released the latest results from a review into breast implants and tissue expander. Following the extensive laboratory testing, evidence submitted by the sponsors and manufacturers of breast...
Implant

Custom Devices, Clinical Trials and the Hazards of Precedent

This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices. A surgeon inventor wanted to...
Barcode

Australian TGA To Introduce AusUDI

The Australian regulatory, the Therapeutic Goods Administration (TGA), has announced the intention to introduce an Australian UDI System. There has been much discussion globally around the introduction of such systems....

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