The SA Health Products Regulatory Authority (SAHPRA) has come under pressure this week to formulate a clear directive concerning the use of single-use medical devices as more voices join the call for regulation of these apparatuses.
A Johannesburg-based company, Medi-Q, and the Association of Medical Device Reprocessors (AMDR) are the latest to join the debate on re-use of medical devices.
This week the international trade association, which represents commercial single-use processors and promoting specialised cleaning of these medical devices, said, “We strongly encourage SAHPRA to revisit its guidance on this matter.”
Medi-Q, the country’s first commercial medical device-reprocessing company to be recognised by SAHPRA after it got its licence from the former Medicines Control Council (MCC) in 2017, is also in agreement for a more formal regulation of these devices. . .
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