medical device

Clinical Evidence

Clinical Evidence Insights for Medical Devices in China

Registration of medical devices in China requires a clinical evaluation report (CER) regardless of the device classification. For many, preparing a CER that meets China’s requirements is a daunting challenge...
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EUDAMED is LIVE

The Medical Devices Regulation (EU) 2017/745 and In Vitro Diagnostic Regulation (EU) 2017/746 include use, maintenance and management of a European databank on medical devices (EUDAMED). The database consists of...
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...
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....
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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...

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