GHTF - Global Harmonization Task Force
The Global Harmonization Task Force (GHTF) is a voluntary group of representatives
from national medical device regulatory authorities and the regulated
industry. Since its inception, the GHTF has been comprised of representatives
from five founding members grouped into three geographical areas: Europe,
Asia-Pacific and North America, each of which actively regulates medical
devices using their own unique regulatory framework.
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 regulatory authorities.
The GHTF also serves as an information exchange forum through which countries
with medical device regulatory systems under development can benefit from
the experience of those with existing systems and/or pattern their practices
upon those of GHTF founding members.
Study Group 2
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. The objective of
the adverse event reporting and subsequent evaluations is to improve protection
of the health and safety of patients, users and others by disseminating
information which may reduce the likelihood of, or prevent repetition
of adverse events, or alleviate consequences of such repetition.
A linked system, incorporating adverse event reporting, and vigilance
and post-market surveillance components, will improve the protection of
the health and safety of patients, users and others by reducing the likelihood
of repeated similar adverse events. This occurs through the dissemination
of information between National Competent Authorities (NCAs) which could
be used to prevent the repetition of the adverse events or to alleviate
the consequences of such repetition.
To this end, SG2 developed and piloted, and has now implemented, a successful
NCA Report Exchange Program for high-risk/emergency incidents with medical
devices. A comprehensive and detailed set of reporting criteria underlie
the decision of whether or not a particular incident, or related set of
incidents, should be exchanged. Currently, exchanges of reports are limited
to within the following group of NCAs: Australia, Canada, Switzerland,
Czech Republic, Germany, Japan, Norway, the United Kingdom and the United
States. SG2 is actively involved in developing a procedure for the inclusion
of additional NCAs into the NCA Report Exchange Program. Since the beginning
of the pilot study in January 1999, over 240 reports have been exchanged
on high-risk health issues.
The Inspectorate (and, formerly, the Bureau of Compliance and Enforcement)
has been involved with the GHTF and SG2 since February 1996. The NCA Report
Exchange Program has been an invaluable means for us to learn, in a timely
manner, about high-risk, device-related events occurring around the world.
Furthermore, the exchange program fosters an increased sense of trust
and co-operation between the participating NCAs.
For more information, visit the GHTF's web-site:
 http://www.ghtf.org/
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