Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

East vs West: how Japan’s new auditing system differs from the EU

This article was originally published in Clinica

Executive Summary

What are the main challenges for companies when it comes to demonstrating compliance with Japanese medical device requirements, and particularly those that are different to requirements in markets such as the EU? Amanda Maxwell spoke with Eiko Tabuchi of T?V S?D Japan to find out how regulation of medical devices in Japan compares with the EU since the latest Pharmaceutical and Medical Device Act came into force at the end of 2014

You may also be interested in...



EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions

It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.

Second EU MDR Notified Body Designated In France

Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.

EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency

Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT102483

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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