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...
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....
Are Harmonised Standards facing irrelevance?
There’s been considerable disquiet over the lack of availability of harmonised standards to support the new European Medical Device Regulations (MDR). And rightly so. But harmonisation is already in disarray...
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...
Out They Go – FDA Clears the Store of Guidances
In a now traditional clearing of the store, FDA issued a raft of new guidances at the close of the financial year. Through September to October 10 a total of...
FDA Fashion Parade – Guidance Priorities for Fiscal 2020
Each new fiscal year, FDA sets out its priorities for guidance development and publication over the coming year. It’s always a fascinating insight into the current regulatory fashions, and just...
Regulatory Change in Australia – TGA’s wish list for 2019
TGA works hard to keep up to date in this rapidly changing world and that’s certainly the case this coming year. An indication of reforms to come can be gained...
Brexit – BSi confirms UK issued CE to become invalid
Brexit - this is where the wheels come off: UK (and now Dutch) Notified Body BSi has advised that all UK issued CE certificates become invalid in case of no...
