Medtech Insight 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

UsernamePublicRestriction
UsernamePublicRestriction

Industry wants change to IVD (in vitro diagnostics) regulation in Japan:

This article was originally published in Clinica

Executive Summary

Japanese industry is hoping it can persuade the Ministry of Health and Welfare to establish a new regulatory category for in vitro diagnostics and related instrumentation. Currently IVDs are regulated in the same way as pharmaceuticals in Japan, while the equipment they run on is subject to the medical device approval process. Japan's IVD industry association, the JACR, believes that diagnostic products should be evaluated as a total system.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT081826

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