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February 15, 2018

Will ANVISA’s acceptance of ISO13485 certification be the end of MDSAP?

October 2017 ANVISA, the Brazilian regulatory authority, published resolution RDC no. 183 stating that for medical device manufacturers located outside the Brazilian territory and Mercosur, a different approach regarding granting of Good Manufacturing Practices (GMP) will be taken.
February 12, 2018

18th RAPS Netherlands Chapter meeting

February 06, 2018

The Brexit Challenge: Truth or Dare?

As the month February moves on, we see a storm in the news on the Brexit challenges and opportunities Do we still have time to sit back and relax? Or do we agree with Raphael Hogarth in yesterday’s Times that “it will soon be too late to salvage the Brexit trade talks”?
February 05, 2018

US FDA and EU IVDR diverging in regulatory approach towards genetic testing

With the newly EU IVDR just published and with the US FDA interpretation on current legislation maturing, it is time to reflect on the direction authorities are taking towards genetic testing. On first review, it is clear that there will continue to be significant differences between FDA’s application of US laws and regulations and those of the EU in vitro Diagnostics Regulation (EU 2017/746). 
February 01, 2018

What are the effects of the European MDR on Chinese Medical Devices manufacturers?

The new EU-MDR has been published on May 5, 2017 and will come into effect on May 26, 2020. This new Regulation is more explicit than the current legislation, which means that the Medical Device sector will need to increase its general level. To help you understand the impact of the new EU-MDR on the Chinese medical device manufacturers, we have asked two of our experts: Minghua Chen and Jan-Paul van Loon, to share their first experiences from a regulatory consultant’s perspective.

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