As we introduce a new year, we’ve hit the ground running with new guidance documents published by the Australian regulatory (Therapeutic Goods Administration) in early January. The guidance outlines the requirements for the new Priority review designations For Medical devices (including IVDs). The TGA had discussed the availability of this process as a result of […]
TGA’s new recall procedures went live on the 15th of January 2018. The update includes changes to definitions and descriptions –
removing some of the confusing terminology that previously existed. There’s new processes with greater flexibility and clarity – including some new flow charts. We take a look at how to plan for a recall – it happens to everyone sooner or later.
Australia’s Therapeutic Good Advertising Code is due for a revamp. Current reforms promise a more streamlined approach, more direct TGA control, and tougher penalties for those who get it wrong. But current reforms promise a more streamlined approach, more direct TGA control, and tougher penalties for those who get it wrong. We look at the announced and proposed changes and what this all means for consumers and the industry.
On October 3, the TGA announced a revision to the URPTG, which is accompanied by a 3 month “familiarisation period” before taking effect on 15th January 2018. We take a look at the new expectations TGA has of manufacturers and sponsors. What would you do – are you prepared for a recall?
The annual TGA Sponsor Information day provides a focused full day program on Australian regulatory requirements. here from TGA officials and leading industry experts on how it all works. Still time to register….
Sponsors of AIMD, Class III, IIb implants and Class 4 IVDs are required to submit annual postmarket reports to TGA for 3 years after first registration. Failure to do so is an offense and risks cancellation of the registration. The deadline for this year’s reports is drawing close.