South Africa licenses the seller years before the device

One statute, licensing companies since 2017

The South African Health Products Regulatory Authority, created by a 2015 amendment to the Medicines and Related Substances Act, 1965 (Act 101 of 1965) and operational since 2018, replaced the old Medicines Control Council as the country's device regulator. Since 2017, holding a Medical Device Establishment Licence has been mandatory for any manufacturer, distributor, importer, or wholesaler doing business in South Africa. The application lists every device the company handles and declares the state of its quality management system — but the licence that results covers the company. It doesn't say anything, on its own, about any device on that list.

A device on the list isn't a registered device

That's the same split this blog has already traced in Canada's own two-register system: an establishment licence answers for the business, a separate device-specific credential answers for the product, and neither substitutes for the other. South Africa's second register — full product registration, at the device level — has been a standing, unfinished project since establishment licensing became mandatory. SAHPRA is rolling it out through what it calls a Registration Call-Up Plan: formal notice, published by device category, telling manufacturers when their devices actually have to register. Until a call-up reaches a given category, the device can lawfully keep selling under nothing but its establishment's own licence.

The queue runs on risk, not on how long you've waited

SAHPRA has said the call-up will prioritize higher-risk devices and products that matter most to public health, not devices in the order they first reached the market. A pilot registration feasibility study for selected high-risk devices and in vitro diagnostics — HIV and TB tests among them — began in May 2024, well ahead of any general call-up for lower-risk categories. A device that's been sold in South Africa for a decade under establishment-only oversight hasn't earned an exemption by tenure; it's simply further back in a queue SAHPRA is ordering by risk class, and its own call-up date isn't predictable from how long it's already been on shelves.

Reference-market proof only matters once you're called

When a call-up does reach a device, the evidence it demands isn't uniform across classes. Class C and D devices have to show proof of market authorization in an approved reference market — Australia, Brazil, Canada, Japan, the EU, or the US — on top of a valid ISO 13485 certificate from a SAHPRA-recognized conformity assessment body, itself only mandatory for new and renewal establishment licences since mid-2025. A device holding strong approvals in every one of those reference markets gains nothing from them in South Africa until its own category is actually called up; the credential sits ready, unused, until the queue reaches it.

Where this meets the file

A South Africa row in a cross-border registration tracker needs two status fields, not one: establishment-licence status, which has had a real compliance date since 2017, and product-registration status, which stays “not yet called up” for most device categories until SAHPRA's own plan says otherwise. Collapsing those into a single “South Africa: licensed” checkbox states a fact about the company as if it were a fact about the device — exactly the gap the phase-in was built to leave open. A tracker built around that two-field structure, alongside the launch catalog's other cross-border templates, is previewed there now. If SAHPRA has called up a category your program tracks, the shelf takes that correction directly.