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Guidance Documents: GLOBAL

In 1992, a global initiative was launched by members of the regulatory agencies of Europe, USA, Canada, Japan and Australia, which became know as the Global Harmonization Task Force (GHTF), comprising regulatory authorities and iductry representatives, with the objective of trying to ensure that future regulation of medical devices across these five regions was, as far as possible, harmonized. One of the first publications from the GHTF was a set of ‘Essential Principles’ (similar to the European ‘Essential Requirements’) that would, hopefully, be accepted as the foundation of medical device regulations by all countries concerned.

The Essential Principles model, together with may other guidance documents producwed by GHTF, was adopted by a number of countries around the world that were in the process of developing regulations governing the manufacture and supply of medical devices. One of the successes of the GHTF model was the publication in May 2012 of a GHTF-based Medical Devices Directive that will eventually be adopted by the ten ASEAN countries: Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. This is in addition to the success of the Asian Harmonization Working Party (AHWP) in bringing together the ASEAN countries with Abu Dhabi, Chile, China, Chinese Taipei, Hong Kong, India, Jordan, Korea, Kuwait, Pakistan, Saudi Arabia, South Africa, and Yemen, to improve medical device regulatory harmonization.

Unfortunately, the founding member countries of the GHTF have, for many reasons, taken the opposite route, and divergence of medical device requirements has occurred, despite government commitments to the contrary.

The GHTF has now been disbanded by its founder members in favour of a ‘regulatory authorities only’ agency, the International Medical Device Regulators Forum (IMDRF) which has taken over responsibility for maintaining GHTF guidance documents. The IMDRF will start to publish its own guidance document, but from the real promise of 1992, there is no fresh optimism that, 20 years on, IMDRF will have any greater success in achieving the commendable aims of the GHTF.