Jenny Lin

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...
Transition

Make your transition from MDD to MDR – White Paper

By Jenny Lin | 30 August, 2019
With less than one year remaining for the transition to the Medical Device Regulation (MDR), this white paper takes a look at the key areas to be addressed for manufacturers...

Search

Recent Posts

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

Chemical Characterisation – no simple matter

Aug 28, 2020

Multiple Function Devices

Aug 26, 2020

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

Aug 10, 2020

Categories

Categories

Archives

Archives

Archives

Tags

510(k) APAC Australia Biocompatibility Brexit CE CE Certificates clinical trials coronavirus COVID-19 COVID19 de novo distribution 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