Medtech Insight 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

Japan’s Rejection Of Foreign Trial Data Continues To Harry Newcomers

This article was originally published in The Gray Sheet

Executive Summary

Small and mid-size device companies seeking product approval in Japan will encounter resistance to international trial data, according to Pacific Bridge Medical (PBM) President Ames Gross

You may also be interested in...



Japan Promises To Wipe Application Backlog, Embrace Foreign Data In 2006

Japan vows to eliminate its backlog of device applications by October in a June 29 report on regulatory reform efforts in the U.S. and Japan

Japan Promises To Wipe Application Backlog, Embrace Foreign Data In 2006

Japan vows to eliminate its backlog of device applications by October in a June 29 report on regulatory reform efforts in the U.S. and Japan

BSD Medical Plans To File PMA For Cancer Therapy, Prepares Japanese Strategy

BSD Medical plans to submit a PMA application by the end of the quarter for its non-invasive BSD-2000 tumor hyperthermia therapy system to treat cancer

Related Content

UsernamePublicRestriction

Register

LL1134786

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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