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South Africa to Implement First Regulations for Devices, Diagnostics

August 29, 2016

South Africa’s Medicines Control Council is gearing up to implement the country’s first regulatory system covering medical devices and in vitro diagnostics.

The new regulations are covered in four separate documents that cover licensing and importing medical devices and IVDs, classification of devices and IVDs, good manufacturing practices, and general safety principles.

The Medicines Control Council released the proposed regulations in September 2015, and sought public comments.

The updated regulations lay out a risk-based classification system based on good manufacturing practices. The updated document provides additional information on postmarketing safety requirements and reporting adverse events. — Tamra Sami

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