In Vivo is part 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

UsernamePublicRestriction
UsernamePublicRestriction

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

Executive Summary

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?

You may also be interested in...



India's Stent Price Slash Creating Climate Of Fear, Foreign Device-Makers Say

An association representing international research-based medtech companies says the Indian government’s imposition of stiff price controls on cardiac stents has sown an “atmosphere of fear” in the industry, and it warns that the move could stifle patient access to innovative treatments.

Asia Reg Roundup: Malaysia, Vietnam & India Speed Ahead In 2017

Progress on ratifying the ASEAN Medical Device Directive (AMDD) continues apace, with some of the Association of Southeast Asian Nations members surging ahead. Malaysia and Vietnam, in particular, are making big efforts to build or strengthen their national regulatory systems foe devices. Also, non-ASEAN state India is taking real steps in a similar direction, say Asia Regulatory Professional Association (ARPA) secretary Jack Wong and ARQon consultant May Ng in this latest Asian regulatory update.

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.

Topics

UsernamePublicRestriction

Register

IV005053

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel