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South Africa Reg System Finally Up And Running, But Medtechs Wary Over Costs

Executive Summary

South Africa's medical devices and IVDs industry crossed the first major threshold of the new national regulatory system on August 24 – the deadline for South African medtech establishments to register under the new regulations. Momentum is increasing, but so are the costs to industry, and they will ramp up further when product licensing – the next phase – kicks in.

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South African Medtech Reg: Pieces Coming Together, As August Deadline Approaches

South African medtech firms have been given until August 24 to license their business establishments and list (but not actually register) their products. There is controversy over the fees and a growing list of tasks for industry and the government, but the key pieces generally seeming to be falling into place to support standing up a South African medtech regulatory system.

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