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Latest From Ed Rozynski
The EU MDR and IVDR have finally been adopted, which is good news in the sense that regulatory certainty is guaranteed, but bad news in terms of the extra compliance costs that industry, including US medtechs, will have to face in the coming years.
Late to the regulatory game India's government authorities may be, but device companies need to be on their toes to not lose out on vast future market opportunities as the "Make in India" program takes shape. That is the view of international device regulatory and market access expert Ed Rozynski. And while India is on the up, is Japan losing its attractiveness?
Recent days have seen a welter of industry association concern following the European Parliament’s ENVI committee’s vote on the
Brazil's medicines and medical devices regulatory authority, Anvisa, is not overlooking the needs of smaller device manufacturers as it moves to simplify and align its regulatory processes with those of established major countries.
In this article, international medical device consultant Ed Rozynski provides insight into his experience of bringing together western medtech companies and healthcare providers in emerging markets, and offers tips on how to make those meetings as successful as possible
Commercial success in the newly-emerging markets takes more than just showing up with a good product, says medical device advocate Ed Rozynski. Penetrating the BRIC markets requires a different skill set to that used by medtechs entering the US and European markets a generation ago, he writes in this special report for Clinica