Devicemakers creating combination products should expect international regulatory agencies to use appropriate elements of more than one model when determining the necessary evidence, evaluation and quality requirements for the products. Guidance documents developed for such products should be flexible to allow for their use in countries with either well-established regulatory systems or less-established systems, Larry Kelly, official at Australia’s Therapeutic Goods Administration, said.
The Global Harmonization Task Force (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.