US FDA Pushes For Increased GHTF Participation At Home And Abroad

Increasing the participation of Asian countries in the Global Harmonization Task Force (GHTF) is the most important issue facing it. By increasing the participation of China, South Korea and members of the Association of Southeast Asian Nations in the GHTF, other countries would have more confidence in the safety of devices imported from Asia, Timothy Ulatowski said at the Medical Device Manufacturers Association annual meeting.

Timothy Ulatowski is head of the US delegation to the GHTF and director of the Office of Compliance at the US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health.

The GHTF was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices. 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. Beginning in 2006, membership expands to include three Liaison Body members: Asian Harmonization Working Party (AHWP), International Organization for Standardization (ISO), and International Electrotechnical Commission (IEC).

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. The primary way in which this purpose is accomplished is via the publication and dissemination of harmonized documents on basic regulatory practices. These documents, which are developed by five different GHTF Study Groups, provide a model for the regulation of medical devices that can then be adopted/implemented by national regulatory authorities.

The GHTF also serves as an information exchange forum through which countries with medical device regulatory systems can benefit from the experience of other members.