MDSAP

Door closed

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

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

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

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)

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

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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