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South Africa readies for new medtech regulatory basis in 2011

This article was originally published in SRA

Executive Summary

South Africa is due to launch proposals and a consultation that should see the emergence of a full regulatory system for devices and diagnostics later this year. This, together with new plans to introduce health technology assessment principles and a new code of conduct for healthcare marketers, means the country is on the threshold of becoming a member of the internationally harmonised industry. This is very good news, Tanya Vogt, the chief operating officer of the South African medical devices industry association, SAMED, told Ashley Yeo.

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