What you need to know about disinfectants in Australia
In May 2020, we looked at hand sanitisers and TGA’s exemption on certain formations in response to the COVID-19 emergency. As we are seeing an increasing number of corporations receiving...
TGA published review of safety and performance issues in Medical Device software
Software as a Medical Device (SaMD) In recent years software usage has become ubiquitous and software resources, particularly mobile apps accessible through smartphones, have increased in complexity and usage. The...
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...
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...
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...
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...
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...
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...
