Arthur Brandwood

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China restricts export of COVID-19 supplies to approved products only

In response to alarming reports of defective COVID-19 test kits, face masks and other emergency supplies, China has taken swift action to restrict the export of medical products which are...
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Expedite! Emergency device regulatory approvals in a pandemic

These are difficult times – and we need fast, really fast, regulatory reviews. So how does this work – how have regulators adapted to the COVID-19 pandemic? What new and...
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....
Brexit

Brexit appears inevitable – and it seems UK MHRA will emulate New Zealand!

As the dust settles on the UK general election, it appears that Brexit is inevitable, it's only a matter of short term timing and terms. So what does this mean...
Door closed

The door to Europe is closed – so where else should I look?

Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
Standards

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...
End of financial year

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...
Red carpet

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...
Implant

Custom Devices, Clinical Trials and the Hazards of Precedent

This past week an interesting post cropped up in the RAPS discussion board. An Australian member asked about doing clinical trials of custom-made medical devices. A surgeon inventor wanted to...

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