MHRA

Brexit Aus image

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

By Grant Bennett | 30 January, 2020
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...
shutterstock_37614649

Australian Regulator Prepares for the Brexit Fallout

By Grant Bennett | 28 March, 2019
Following our earlier article Fog in the Channel: a European Medtech Perspective on Brexit where we outlined the need for the EU and UK to manage the pending fallout of...

Search

Recent Posts

That’s ODD: can your medicine benefit from incentives for treating rare disorders?

Jul 31, 2020

TGA published review of safety and performance issues in Medical Device software

Jul 29, 2020

Risk Management ISO Standards – ISO 14971: 2019 and ISO TR 24971: 2019.

Jul 22, 2020

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

Jul 2, 2020

FAQs Regarding the Australian R&D Tax Incentive and Regulatory Services

Jul 1, 2020

Addendum to TGA Deadlines: Medicine Labelling Compliance and COVID-19

Jun 19, 2020

Categories

Categories

Archives

Archives

Archives

Tags

510(k) APAC Australia Biocompatibility Brexit CE CE Certificates clinical trials coronavirus COVID19 de novo distribution EU Europe FDA GHTF Harmonization IMDRF IVD IVDD IVDR MDD MDR MDSAP medical device Medical Device Regulations medical devices medicines MHRA New Zealand Notified Bodies Pharmaceutical PMA PMDA postmarket private health insurance Quality Systems Reform regulatory Reimbursement SaMD Software standards TGA UDI