Services

One South African entity for your regulatory presence.

Selling a medical device in South Africa requires a local, SAHPRA-licensed establishment to be responsible for it. Most international manufacturers don't want to build one. IXCIO is that entity.

Core service

Licence holding & authorised representation

IXCIO acts as your authorised representative in South Africa and as the licensed establishment your device registration is held under. You retain ownership of your product, your data and your commercial relationships; IXCIO carries the local regulatory responsibility.

This is the service that removes the need to incorporate, staff and license a South African subsidiary before you have any local revenue.

What's included

Authorised representative appointment and mandate
Holding your SAHPRA registration under IXCIO's establishment licence
Regulatory correspondence with SAHPRA on your behalf
Licence and registration maintenance, renewals and variations
Coordination with your chosen importer and distributor
Post-market obligations: vigilance reporting and record-keeping

Licence status. IXCIO is establishing as a SAHPRA-licensed authorised representative. Ask us for the current position when you enquire; we will tell you exactly where the application stands and what that means for your timeline.

Scope. Where a task falls outside what IXCIO performs directly, we manage it through vetted South African specialists under a single engagement. You have one point of contact throughout.

Registration

SAHPRA registration

The route to SAHPRA registration depends on your device's classification, its intended use and which reference-market approvals you already hold. IXCIO assesses the pathway first, then runs the submission.

What's included

Pathway and classification assessment against South African rules
Reliance strategy: how your FDA, EU MDR or UKCA approval can be used, and where it can't
Technical documentation review and localisation
Submission preparation and lodging
Query handling through to decision

A word on "reliance". SAHPRA can take account of assessments by recognised reference regulators, but the extent to which that shortens your route is product-specific. We'll give you a straight answer for your device rather than a general promise.

Phased requirements. South Africa's device registration is being phased in by risk class. Whether your device must be registered today, or only licensed for now, is one of the first things we establish.

Advisory

Regulatory advisory

IXCIO's specialism is software as a medical device and AI-enabled devices — the products where classification, change management and post-market evidence are hardest to get right, and where South African practice is still developing.

Typical engagements

Determining whether your software is a medical device in South Africa, and its class
Mapping your existing regulatory position onto South African requirements
Post-market surveillance and vigilance set-up for a local market
Importer, distributor and establishment-licensing structure
Introductions to South African distributors, clinical partners and specialists

What to have ready

The facts that determine your pathway. You don't need all of them to start a conversation, but they shorten it.

Intended use statement
Classification in your reference market
Approvals held (FDA, CE, UKCA, other)
QMS certification (e.g. ISO 13485)
Whether the device includes software or AI/ML
Existing or intended South African distributor
Target customers: private, public, or both

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