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

China Medical Device Regulations – Major Updates

Apr 8, 2021

European Medical Devices Regulation (EU MDR) Implementation date is just around the corner

Mar 30, 2021

Technical File Differences Between Medical Devices and IVD Medical Devices

Mar 26, 2021

Taiwan FDA Unique Device Identifier (UDI) Draft Regulation

Mar 8, 2021

Hitting the Accelerator

Mar 4, 2021

Prescription Medicine Pathways

Feb 25, 2021

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