Official requirements
We check current classification information from SAHPRA and government websites and show you the source links.
Free AI tool
No signup required
Free South Africa medical device classification tool
Describe your device and get a preliminary SAHPRA risk class, a clear explanation, official source links, and similar registered products where available.
Describe your device
Tell us what the device does, who uses it, how it contacts the body, and whether it is powered, implantable, sterile, measuring, software, or an IVD.
Preliminary informational result—not an official regulatory decision.0/5,000
How it works
What the South Africa classifier checks
The classifier compares your product description with current SAHPRA classification requirements. It then gives you a suggested class, explains why it may apply, and shows the source links and product examples behind the result.
Your product details
Intended use, body contact, duration, power source, sterility, software functions, and other details can change the class.
A clear preliminary answer
You receive a suggested risk class, the reasons it may apply, and what should be confirmed before filing.
Frequently asked questions
South Africa medical device classification FAQ
How are medical devices classified in South Africa?
SAHPRA uses a risk-based framework. Risk classes A through D. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.
Is this South Africa medical device classification tool free?
Yes. The preliminary SAHPRA classifier is free to use and does not require an account. Fair-use limits help keep it available to everyone.
What information does the South Africa classifier use?
Current official SAHPRA classification requirements. Your result includes an explanation and links to the official sources used.
Is the result an official SAHPRA classification decision?
No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.
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