Course Description

Introduction to the GHTF or IMDRF

Course Description:

This course introduces the Global Harmonization Task Force (GHTF)—now referred to as the International Medical Device Regulatory Forum (IMDRF)—and outlines its goals, organizational process, and recommendations for a harmonized regulatory model. It also looks at the future of global harmonization.

Watch the Course Trailer:



Learning Objectives:

Upon successfully completing this course, trainees will be able to:

  • Understand the structure and functions of the GHTF/IMDRF
  • Grasp the basic concepts of its recommendations for a harmonized regulatory system for medical devices
  • Apply the mechanisms for carrying such recommendations forward

Who Should Enroll:

Regulatory affair, quality assurance, and clinical professionals in the industry, and regulators with an interest in the global market are all welcome to participate in this course.

Prerequisite Knowledge/Requirements:

There is no prerequisite knowledge required for this course; it is an introductory course for regulatory professionals.

Subject Matter Expert:
Shelley Tang

25 min

Related resources:

Case studies:

Peer review:
Martin de Bruin

Change Currency:
Under review !!