Medical Device Link.

Originally Published MX May/June 2004

MARKET ANALYSIS

Coping with the variety of regulatory schemes that are in use by countries throughout the world can be a difficult task for a manufacturer hoping to break into new markets. But the task might have been impossible if it were not for the work of the Global Harmonization Task Force (GHTF) over the past decade.

The GHTF is a voluntary group of representatives from national medical device regulatory authorities and regulated industry. Since its inception, the GHTF has been comprised of representatives from five founding members, Australia, Canada, the European Union, Japan, and the United States. Members of the task force are grouped into three geographical areas—Europe, Asia-Pacific, and North America—each of which actively regulates medical devices using its 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. These goals are accomplished primarily through the publication and dissemination of harmonized guidance documents on basic regulatory practices. These documents, which are developed by four GHTF study groups, can then be adopted and 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, enabling them to pattern their practices upon those of GHTF founding members.

Additional information about the GHTF can be found on the task force Web site at www.ghtf.org.

Copyright ©2004 MX