MDSAP

Door closed

The door to Europe is closed – so where else should I look?

By Arthur Brandwood | 2 December, 2019
Early in 2019, the European commission was promising that by end of year MDR implementation would be well underway. There would be substantial numbers of Notified Bodies designated to perform...
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Japan renews its participation in MDSAP until 2020

By Luis Jimenez | 2 May, 2019
Japan’s participation in MDSAP (Medical Device Standardized Audit Program) has been a contributing factor in the exponential update of MDSAP by multinational companies. Japan’s MHLW and PMDA has been opting...
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Asia-Pacific Med Dev Change Opens Up New Opportunity

By Grant Bennett | 1 May, 2019
Rapid regulatory change is normal in the emerging (and established) medical device markets of the Asia Pacific. Substantial changes in 2018 were no exception, including in some cases, whole new...
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MDSAP Stakeholder Update (FDA, TGA, Health Canada, PMDA, ANVISA)

By Luis Jimenez | 21 December, 2018
On Dec 5th, 2018 the representatives from US FDA, Brazil’s Anvisa, Japan’s PMDA, Australia’s TGA, and Health Canada met in Washington, DC with stakeholders from the medical device industry to...
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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...

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Recent Posts

TGA expedites COVID-19 approvals, while keeping up business as usual for other devices

Apr 2, 2020

Expedite! Emergency device regulatory approvals in a pandemic

Apr 2, 2020

The EC confirms they are working on a proposal to delay MDR deadline amidst COVID Pandemic

Apr 2, 2020

Six uncomfortable regulatory truths in a pandemic

Mar 25, 2020

Getting Shorty – Meeting your obligations for Reporting Medicines Shortages in Australia

Mar 24, 2020

Keeping the genie in the bottle – managing genetically modified organisms (GMOs) in Australia

Feb 26, 2020

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