PMA

FDA

FDA raises fees 4%

By Arthur Brandwood | 27 September, 2018
The new US financial year as always heralds increases in regulatory fees.  FDA published its 2019 fees at end of July. Fees are up around 4% across the board. The...
Uncertainty

Risk vs. Benefit FDA guidance gets to grips with uncertainty

By Arthur Brandwood | 27 September, 2018
Doing risk management in an uncertain world is why regulatory affairs are as much art as science. Innovators will continue to push the envelope of the possible while regulators will...
Brandwood Biomedical global experts medical devices regulatory affairs consulting medical devices IVDs Brandwood Biomedical Global Expertise in Medical Device Regulatory Compliance Australia China Taiwan Hong Kong Europe New Zealand United States

Australia via 510(k): TGA – recognises US, Canadian and Japanese approvals with MDSAP

By Arthur Brandwood | 30 August, 2018
Australia’s regulatory system is modelled very closely on that of Europe. This equivalence of requirements and assessment pathways has allowed TGA to leverage prior CE marking to grant Australian device...

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