medical device

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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...
Grant Feb artgicle image

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...
Reform

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...
Australiabrexit

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

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...
Gandalf

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 article image

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...
KPI

TGA Releases Self-Assessment July-June 2018

As a final gift to members of the regulatory profession (or anyone who has an interest in bringing product to the Australian market), the Therapeutic Goods Administration (TGA) announced the...
apple-watch-3-2

Not so fast. What really happened with FDA’s clearance of the Apple Watch ECG

There’s lots of noise about the very rapid de novo clearances for Apple’s “Irregular Rhythm Notification Feature” (DEN 180042) and ECG App (DEN180044) for the Apple Watch. FDA cleared both...
Watch

Software as Medical Devices (SaMD) Growing Regulatory Trends and Opportunities for Innovators

With SaMD attracting larger players and devices like the Apple Watch, FDA and regulators globally, are developing frameworks for regulating these more efficiently. On Sept 11th, 2018 Apple obtained FDA...

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