The Global Harmonization
Task Force (GHTF) is a voluntary international consortium of public
health officials responsible for administering national medical device
regulatory systems and representatives from the regulated industry.
Since its inception, the GHTF has been comprised of representatives
from five governments (grouped into three geographical areas, ie. Europe,
Asia-Pacific and North America), each of which actively regulates medical
devices under their own unique regulatory system.
The purpose of
the GHTF is to encourage convergence in regulatory practices related
to ensuring the safety, effectiveness / performance and quality of medical
devices, promoting technological innovation and facilitating international
trade, and the primary way in which this is accomplished is via the
publication and dissemination of harmonized guidance documents on basic
regulatory practices. These documents, which are developed by four (4)
different GHTF Study Groups can then be adopted/implemented by member
national control authorities.
Study Group 1:
SG1 has been charged
with comparing operational medical device regulatory systems around
the world and from that comparison, isolating the elements / principles
that are suitable for harmonization and those that may present obstacles
to uniform regulations. In addition, the group is also responsible for
developing a standardized format for pre-market submissions and harmonized
product labelling requirements.
Study Group 2:
SG2 is charged with
the task of reviewing current adverse event reporting , post-market
surveillance and other forms of vigilance for medical devices and performing
an analysis of different requirements amongst countries with developed
device regulatory systems with a view to harmonizing data collection
and reporting systems.
Study Group 3:
SG3 is responsible
for the task of examining existing quality system requirements in countries
having developed device regulatory systems and identifying areas suitable
for harmonization.
Study Group 4:
SG4 has been charged
with the task of examining quality system auditing practices (initially
among the founding members of the GHTF) and developing guidance documents
laying harmonized principles for the medical device auditing process.
