News

SAHPRA launches programme to register medical devices

02 Oct 2025

The SA Health Products Regulatory Authority (SAHPRA) has announced that it plans to introduce the registration of medical devices in a phased manner, “starting with the highest-risk products, such as heart valves, and working down to lower-risk items”. – Spotlight (2 October2025)
The registration will address the urgent need for comprehensive oversight of the more than 2m types of medical devices used globally, with over 200,000 of these devices on the SA market.
The process will start by conducting a feasibility study, initially focusing on 32 devices used for HIV and TB, including diagnostic tests, condoms, and X-ray equipment.
“For devices already approved by trusted international regulators (in the EU, Australia, or Japan), SAHPRA can use their assessments to inform its own registration decisions. Devices not approved elsewhere must undergo a safety and performance assessment by a locally accredited body before SAHPRA will consider them for approval.”

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