IXCIO becomes your South African licence holder and authorised representative, registers your device with SAHPRA, and keeps it compliant — so you don't need to set up a local entity to sell here.
One South African entity. One contract. Regulatory pathway to market.
You keep your existing approvals and your commercial relationships. IXCIO supplies the South African regulatory entity that sits between them.
FDA, EU MDR, UKCA or another reference-market approval, plus your technical documentation and quality system.
Licence holder and authorised representative. SAHPRA registration held under IXCIO. Ongoing regulatory correspondence and compliance.
Private healthcare, distributors, health systems and public procurement — through the partners you choose, with IXCIO as the regulatory backbone.
IXCIO acts as your South African authorised representative and the licensed establishment your registration sits under.
Pathway assessment, classification, reliance on your reference-market approval where available, and the submission itself.
Specialist support on SaMD and AI-enabled devices, post-market obligations, and how South African requirements map to what you already hold.
6–8 October 2026 · Gallagher Convention Centre, Johannesburg
IXCIO will be at WHX to meet manufacturers exploring South African entry. Book a slot before the event, or send your product details and we'll find you on the floor.
IXCIO is run by a South African regulatory affairs specialist focused on AI-enabled medical devices and software as a medical device, with a research background in post-market surveillance and regulatory reliance across African jurisdictions.
IXCIO is also behind Aletia Index, an independent regulatory-intelligence initiative tracking AI/ML medical device regulation across major jurisdictions.
Before you get in touch, it helps to have to hand: your device's intended use, its classification in your reference market, which approvals you hold, your quality-system certification, and whether you already have a South African distributor in mind. The enquiry form asks for exactly these.