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....
Fog in the Channel: a European Medtech Perspective on Brexit
An apocryphal newspaper headline reported, "Fog in the Channel - Continent Cut Off". All very whimsical and a metaphor for a peculiarly anglo-centric world view. But as the UK stumbles...
Australian regulator closes in on Class I devices
In 2014, the Australian Government announced the Expert Panel Review of Medicines and Medical Devices Regulation, which was tasked to assess and provide feedback on the regulatory framework for medicines...
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...
How a No Deal Brexit may Jeopardise Medical Device Supply in Australia
This is not just a political temper tantrum in a small Island somewhere off the coast of France. Brexit will have global implications: including some strange effects in markets far...
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...
New Zealand WANDers towards increased device regulation
If you are WANDering about the title of this blog, yes, it’s a dreadful pun I know – but it’s that time of year. New Zealand’s Medsafe have issued a...
MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)
On Dec 5th, 2018 the representatives from US FDA, Brazil’s Anvisa, Japan’s PMDA, Australia’s TGA, and Health Canada met in Washington, DC with stakeholders from the medical device industry to...
