Content area
Full Text
The Global Harmonization Task Force (GHTF) was founded in 1992 to respond to the growing need for international harmonization in the regulation of medical devices. With an increasingly global marketplace, national regulations and guidelines are often not enough to ensure patient safety and access to safe, effective, and clinically beneficial medical technologies around the world.
The GHTF comprises a voluntary group of representatives from regulatory authorities and regulated industries. There are five founding members grouped into three geographical areas: Europe, Asia-Pacific, and North America. These three areas each have their own infrastructure for regulating medical devices. Because of this autonomy, the harmonization efforts of the GHTF over the years have benefited from the natural checks and balances system that can only strengthen a unified approach.
In 2006, the member groups expanded to include three liaison body members: the Asian Harmonization Working Party (AHWP), the International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC).
Structure
The GHTF Steering Committee provides policy and direction. It is responsible for the assignment and oversight of new work items, adopting and monitoring GHTF guidance documents, and authorizing and promoting GHTF training opportunities. Study groups oversee different areas of the GHTF's work. Liaison bodies are public health organizations, international standard-setting bodies, or other groups who can contribute to or benefit from participation in the GHTF. Liaison bodies are encouraged to promote GHTF guidelines to their members and incorporate them into their work. They are permitted to nominate observers for GHTF Study Groups as well as other expert working groups.
The ultimate goal of the GHTF is to use these varied regulatory practices and unify their approach to ensure that medical devices are safe and effective and that they perform as specified. The other benefits of this convergence are to indirectly promote technological innovation and international trade.
The objectives of GHTF are to:
(A) Encourage the development of a harmonized regulatory environment, allowing for better protection of public health and thereby facilitating the availability of medical technologies consistent with state-of-the-art and current knowledge.
(B) Develop guidance documents and recommended procedures in order to work toward convergence...