South Africa Reg System Finally Up And Running, But Medtechs Wary Over Costs
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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The long-awaited South Africa Health Products Regulatory Authority (SAHPRA) came of age in February 2018, replacing the Medicines Control Council. The authority has inherited a major backlog of drug-products regulatory work, but the local medical devices industry has high hopes of better, faster regulation, and a higher profile on the international front too.
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.
South Africa Medtech Reg: As New System Nears Finish Line, Device-Drug Distinctions Still Need Highlighting
Stakeholders pushing for a dedicated medtech regulatory system in South Africa have been in sight of the finish line on several occasions in recent years, only for obstacles to rise. But a new structure is almost in place with the enactment of key rules this month. The country's device industry group, meanwhile, is still working to ensure the government fully appreciates important distinctions between devices and drugs.