IVD

Checklist

Australia’s TGA releases updated Essential Principles Checklist

In Australia, for any given device, irrespective of risk classification, manufacturers must demonstrate compliance with the Therapeutic Goods Administration (TGA) essential principles. The essential principles define the requirements for the...
Winding Road

European Medical Devices Regulation (EU MDR) Implementation date is just around the corner

As the long-awaited deadline for the implementation of the European Medical Devices Regulations (EU MDR) finally draws near, it is now more important than ever to understand the applicable deadlines...
shutterstock_1754584295 (1)

Technical File Differences Between Medical Devices and IVD Medical Devices

With the Medical Device Regulations (MDR) coming into force from 26 May 2021 and the upcoming In Vitro Diagnostics Regulations (IVDR) from 26 May 2022, the regulatory requirements are finally...
shutterstock_534246544 (1)

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...
shutterstock_1387185536 (1)

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...
Time passing

TGA expedites COVID-19 approvals, while keeping up business as usual for other devices

The TGA continues to provide timely responses and support for new applications and emergency use applications. Our firm continues to be in active communication with the agency, which at the...
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....
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...

Search

Recent Posts

Categories

Categories

Archives

Archives

Archives