medical devices

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Harmonised Standards for MDR? CEN/CENELEC say “Non”

Back in November 2019, looking at the virtual break down in harmonisation of standards to the European Directives and the belated request from the Commission for harmonisation to MDR of...
Restricted

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...
Deadline extended

Some Class I Device Transitions Extended – MDR

Under growing pressure from industry and notified bodies, the need to provide some breathing space around MDR deadlines by the European Commission has finally been considered. After much focus on...
Brexit Aus image

And out they go…BREXIT is final! But what about Australia?

After several years of leadership changes, elections and conspiracies, we’ve finally arrived at the exit gate. Effectively, with no deal being reached, the implications to the UK are significant, however...
Process copy 2

A single review program for medical devices?

During this year’s Bio-Utah Summit in November 2019, Dr. Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health (CDRH) spoke about the new initiatives and modernization of...
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...
Stairs with light

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...
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...

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