Medical Device is a highly regulated item. Technical requirement and regulation is changing rapidly. Many Asian countries are developing their regulatory system and more regulatory expertise is required. During the 2005 Global Harmonization Working Party (GHWP) meeting, members agreed the need to develop a systemic training program and Hong Kong industry was assigned to lead the project.
The Australian Therapeutic Goods Administration (TGA), together with the Medical Technology Association of Australia (MTAA), the Global Harmonization Working Party (GHWP), and the U.S. Department of Commerce, presents the latest in the series of APEC funded projects educating regulators on global harmonization of medical device regulation. Participation in the Asia delegation visit will help you as a regulator better understand global medical device regulations and the emerging similarities between them. The focus of the delegation visit will be training, laboratory visits, and training conducted by regulatory government and industry regulatory experts involved in the Global Harmonization Task Force (GHTF), with a concentration on how one of the GHTF founding members (Australian TGA) implements their regulatory regime including auditing, quality system and surveillance issues.
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