Medical devices – from gloves and dressings to monitors and hospital beds – are regulated in South Africa by the South African Health Products Regulatory Authority (SAHPRA). Before you place an order, especially a large or repeat one, it is worth checking that your supplier is licensed.
Who needs a SAHPRA licence?
According to SAHPRA, a medical device establishment licence is required by anyone who manufactures, imports, exports, distributes or wholesales medical devices, including in-vitro diagnostic (IVD) devices. SAHPRA also states that licence holders who use third parties must make sure those third parties hold their own licence.
How to check a supplier
- Ask the supplier for its licence number and the exact registered company name.
- Go to the SAHPRA website (sahpra.org.za), open Databases & Registers and choose Medical Devices Licences Issued.
- Search by licence number or company name and check that the name and details match the supplier you are dealing with.
- If you cannot find the licence, SAHPRA asks that queries be sent to mdqueries@sahpra.org.za.
Watch out for false licences
In June 2025 SAHPRA warned the public that some individuals and companies were presenting falsified SAHPRA licences to appear trustworthy. A licence certificate in a brochure or email is not proof on its own – check it against SAHPRA’s own database, and report a suspected fraudulent licence to SAHPRA (toll-free 0800 204 307 at the time of SAHPRA’s notice).
What a licence does and does not tell you
An establishment licence shows that the company is authorised to carry out its activities with medical devices. It is not a review of every individual product. For specific products, ask for the manufacturer’s documentation – for example product specifications, instructions for use and quality certificates – and check that the product matches what your clinicians need.
Ordering through Medlive
Medlive’s product pages show the details we have verified for each product, and you can ask for product documentation when you request a quotation. If you need supplier compliance documents for your procurement file, include that in your request.
Sources: SAHPRA – FAQs, Medical Devices Licensing; SAHPRA media release on falsified licences, 11 June 2025.
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