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Tag: MDSAP

Posted on 20 April 201826 April 2018

CANADA: the MDSAP transition period is about to end

As of January 1, 2019 the MDSAP certificate will be mandatory in order to market Medical Devices (MD) and In …

Continue reading “CANADA: the MDSAP transition period is about to end”

Posted on 16 March 2018

BRAZIL: Brazilian manufacturers may apply for MDSAP certification

The MDSAP (Medical Device Single Audit Program) certification can finally be requested by manufacturers based in Brazil or in other …

Continue reading “BRAZIL: Brazilian manufacturers may apply for MDSAP certification”

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+ IVDR (EU) 2017/746

  • What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?

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  • Is it possible to self-certificate devices in the field of the Regulation on in Vitro Diagnostic Medical Devices IVDR (EU) 2017/746?

  • What is the “sell off” provision?

  • Transitional period: can in vitro diagnostic medical devices, conform to the current IVDD, be placed on the EU market after May 26, 2022?

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