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.