In Vivo is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


Ed Rozynski

Set Alert for Articles By Ed Rozynski

Latest From Ed Rozynski

The Rozy View: US Medtechs Face New Reg Burdens On Entering EU Market

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.

Europe Regulation

The Rozy View: Medtechs, Negotiate With India’s Regulators And Don't Give Up On Japan

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?

Market Access Asia Pacific

EU industry needs all hands on deck to scale back MDR scrutiny clause

Recent days have seen a welter of industry association concern following the European Parliament’s ENVI committee’s vote on the EU Medical Device Regulation (MDR). And I, as the chief US lobbyist on the original Medical Device Directive (MDD, 93/42/EEC), certainly share some of their frustration and consternation.

Medical Device

Brazil's Anvisa thinks both big and small on medtech GMP regulatory changes

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.

Innovation and flexibility will help pave road to emerging medtech markets success

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

Medical Device

Are medtech manufacturers up to the challenges of China, India and Brazil?

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

Medical Device
See All