COVID-19

Covid image Sarah Griffin

Impact of COVID-19 on Medical Device Sales and Reimbursement in Australia

By Sarah Griffin | 10 August 2020
Our reimbursement adviser, Sarah Griffin talks about the impact COVID-19 has had on Sales and Reimbursement in the Australian Medical Device industry. Australia has been very fortunate in that it...
shutterstock_572893948

What you need to know about disinfectants in Australia

By Jenny Lin | 7 August 2020
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...
Picture 1

EC Acts Quickly – and issues proposal to delay MDR deadline amidst COVID Pandemic

By Luis Jimenez | 2 April 2020
With sweeping speed, the European Commission (EC) has issued its proposal to postpone the deadline of the transition from MDD to MDR. The goal is to have the European Parliament...

Search

Recent Posts

TGA Issues guidance for sponsors with lapsing Conformity Assessment Certificates

Oct 19, 2020

TGA will require DOC’s to be submitted for Class I ARTG registrations

Oct 2, 2020

Your guide to claiming temporary exemption from TGO91/92 compliance

Oct 2, 2020

New Guidance on FDA ISO 10993-1

Sep 14, 2020

Australian Prescription Medicine Pathways – Project Orbis

Sep 1, 2020

TGA Advertisement Framework Revisions Hard at Work During Pandemic Times

Aug 31, 2020

Categories

Categories

Archives

Archives

Archives

Tags

510(k) APAC Australia Biocompatibility Brexit CE CE Certificates clinical trials Conformity Assessment coronavirus COVID-19 COVID19 de novo Drug EU Europe FDA guidance ISO 10993-18 IVD IVDD IVDR MDD MDR MDSAP medical device Medical Device Regulations medical devices Medicine medicines New Zealand Notified Bodies Pharmaceutical PMA PMDA postmarket private health insurance Quality Systems Reform regulatory Reimbursement SaMD Software standards TGA