A Brief Look into the Global Harmonization Task Force

July 14, 2011 - PRLog -- A Brief Look into the Global Harmonization Task Force (GHTF)
What is GHTF?
Global Harmonization Task Force (GHTF) was formed in 1992 in order to achieve international harmonization in the medical devices regulation. This is done by exchanging information aimed at standardizing the medical devices regulations across the world. This task force is voluntary and consists of representatives from national medical device regulatory authorities and the regulated industry.
Founding Members of GHTF
The five founding members of GHTF are the European Union, the United States, Canada, Japan and Australia. These members already have a standardized medical device regulatory system that works efficiently in the respective nations.
Geographic Division and Associated Members
The geographic division of the founding members was into three main areas which are Europe, Asia-pacific and North America. The other members that joined the GHTF in 2006 are Asian Harmonization Working Party (AHWP), International Organization for Standardization (ISO), and International Electro technical Commission (IEC).
Participating Members and Liaison Bodies
Other public health organizations, international standard-setting bodies or other groups can participate, contribute and benefit from the GHTF.
Purpose of GHTF
The purpose is multifold
• To encourage convergence of regulatory practices
• Ensure safety and performance efficiency of medical devices though convergence of regulations
• Promote innovation in technology
• Facilitate international trade
Process of Accomplishing the Purpose
Study Groups
GHTF has formed study groups. These study groups publish and harmonize documents pertaining to basic regulatory practices. Presently there are five study groups; each group has a different focus area. Each group consists of one founding member, regulatory agencies and technical experts of medical devices industry. The following are the focus areas of the Study Groups:

Study group 1 - Current medical device regulatory systems
Study group 2 - Medical device vigilance such as medical device reporting and post market surveillance
Study group 3 - Examining and harmonizing current quality systems requirements
Study group 4 - Examining current quality systems auditing practices and the harmonization of
the auditing process
Study group 5 - Convergence of clinical practices

Steering Committee
The Steering Committee is the governing body which is responsible for overseeing the management of GHTF and set policies for the GHTF. This committee consists of up to 4 regulatory and 4 industry members from each founding geographic area namely Europe, North America and the Asia-Pacific.

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