[The global harmonization task force : successes and challenges].
With the move towards globalized international commerce and trade, a call for harmonization of medical device regulatory requirements and practices has evolved. The purpose of the Global Harmonization Task Force (GHTF) is to encourage convergence of regulatory requirements and practices at a global level through consensus to achieve four principle goals: promote safety, quality and performance/effectiveness of medical devices; encourage technological innovation; foster international trade; and serve as a forum of information exchange - all in the interests of protecting and promoting public health. The GHTF is governed by a Steering Committee, and the principle development of the GHTF regulatory model has been, and continues to be, done through five working groups known as Study Groups and supplemented recently by the creation of several Ad Hoc Working Groups. Since its creation in 1992, the members of the GHTF have worked collaboratively to develop what is now ready to be called a global model for the regulation of medical devices.
Global Harmonization Task Force, c/o Medical Devices Bureau, Health Canada , Add. Loc. 0301H1, K1A 0K9, Ottawa, Ontario, Canada. roland_rotter@hc-sc.gc.ca
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D026683:Advisory Committees / Q000458:organization & administration*; D004869:Equipment Safety / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005858:Germany; D038622:Internationality; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D017751:Safety Management / Q000331:legislation & jurisprudence*