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


GHTF Issues Final Guidance Documents On UDI And Device Labeling

This article was originally published in The Gray Sheet

Executive Summary

The Global Harmonization Task Force has released two final guidance documents – on unique device identification systems and device instructions for use – plus four proposed guidelines in recent weeks.

You may also be interested in...

FDA’s UDI Draft Rule Details Device Marking, Database Submission Mandates

The long-anticipated proposal maps out a unique device identifier system that FDA says will be crucial to the future of post-market safety surveillance, recall management and safety alerts. The effort also will help reduce medical errors and bring an array of other benefits, stakeholders say.

Challenges Remain In Linking Unique Device Identifiers To Electronic Health Records

Manufacturers and hospitals have high hopes for the benefits of linking unique device identifiers, still about two years from prime time, to patient electronic health records and registries.

Global Harmonization Task Force To Disband As Focus Shifts To Implementation

The Global Harmonization Task Force as currently formed will disband and be replaced with a new, regulators-only forum focused on implementing harmonized policies across the globe, participants say.

Related Content





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