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

Global Medtech Guidance Tracker: February 2021

Executive Summary

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-eight guidance documents have been posted on the tracker since its last update.

You may also be interested in...



No Eudamed, No Problem! Latest Guidance Explains Alternatives While Database Is Built

Lack of an official explanation about how the exchange of critical information will progress pending the launch of the EU’s medical device database, Eudamed3, has left many confused. New guidance lights the way forward.

New Australian Guide Explains Oversight Of Clinical Decision Support Software

The Australian medtech regulator is urging sponsors of clinical decision support software to review their products to determine if these are regulated, exempted or excluded from regulatory oversight. Much depends on the intended purpose of these products, as stated by the manufacturer.

EU Nitrosamines Oversight Group Identifies Priority Topics

After agreeing on an EU-wide harmonized approach to deal with nitrosamine contamination in medicines, a newly-created regulatory oversight group has identified several topics requiring further scientific discussion.

Topics

UsernamePublicRestriction

Register

MT143599

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