South Africa is the only market on this site where you cannot register your device, because the regulator has not started registering devices. What exists instead is an establishment licence — and it is issued in the name of one named individual who must live in South Africa.
In a communication to industry the regulator states that it "has not commenced with product registration of medical devices and IVDs as per regulation 8", and that anyone intending to import, manufacture or market such a product "shall apply to the Authority for a medical device establishment licence". Its own devices page puts it more plainly still: "The registration process for medical devices is still in development."
The regulations that would create registration were gazetted in December 2016. Regulation 8 provides for it. But registration only bites when SAHPRA issues a call-up notice, and none has been gazetted. A call-up plan was published in 2018 proposing phases from July 2018 to June 2020; those dates have passed without the declaration that would have triggered them.
What has happened since is a voluntary feasibility study, opened in May 2024 and limited to Class C and D devices used against HIV and tuberculosis — with no fee and, expressly, no certificate of registration issued. Its report was published on 31 March 2026. We could not read it: SAHPRA has moved its 2026 documents to a host that refuses automated access, and we are not going to summarise a document we have not opened.
Why this matters commercially, and not just as trivia. Half the market-access industry sells "SAHPRA registration" for medical devices. There is no such thing to sell. What there is, is an establishment licence held by your South African partner — which means the money and the attention belong on who holds it, not on a dossier.
The 2016 regulations define the Authorised Representative as "a natural person, resident in the Republic of South Africa, who has the written mandate to represent a manufacturer, importer, distributor, wholesaler, retailer or service provider". SAHPRA's guidance sharpens it: that individual is the person "in whose name the manufacturer Licence, distributor licence, wholesaler licence and or certificate of registration is issued".
Read that twice if you have entered the other five markets on this site. In Saudi Arabia the licence sits with a licensed company. In the UAE, with a licensed establishment. In Egypt, with one of three corporate applicant types. In Nigeria, with a company holding your power of attorney. In South Africa it sits with a human being, who can resign, emigrate, fall out with your distributor, or be poached by your competitor.
The representative is responsible for all aspects of the device — performance, quality, safety and compliance. SAHPRA publishes no minimum qualification for the role: it requires a curriculum vitae and expresses the standard functionally, as knowledge sufficient to ensure the correct procedures are followed through importation, transport, storage, distribution, marketing and sale.
How we would handle it. Name the individual in your distribution agreement, agree in writing what happens if they leave, and know in advance who the replacement would be. This is the cheapest clause you will ever negotiate and the most expensive one to be without.
CE does. UKCA does not. And the reason is precise enough to be worth stating carefully, because it is exactly the kind of detail a provider working from memory will get wrong.
Scope is expressly human medicines, biologicals, veterinary medicines and variations. Devices are not in it.
The licence application wants evidence of pre-market approval from at least one of those six. UKCA is named nowhere in any SAHPRA device document we read.
So the MHRA is a recognised regulator in South Africa — for medicines. For devices the list is a different list, it is shorter, and Britain is not on it. A UK manufacturer routes its evidence through an EU MDR or IVDR certificate, or through approval in one of the other five.
SAHPRA published a Medical Devices Reliance Guideline — document SAHPGL-MD-22, version 1, dated 25 February 2026. We have its number, version and date from SAHPRA's own index. We could not read it. SAHPRA has migrated its 2026 documents to a host that blocks automated retrieval, and every 2026 guideline, form and communication is in the same position.
That guideline is where the device recognition list could have been aligned with the medicines list — which would put the MHRA on it. Until somebody opens the document, the honest answer is that we do not know, and we would obtain it from SAHPRA directly before advising you to rely on either outcome.
Classes A to D, on rules built from the international harmonisation model. You classify; SAHPRA arbitrates where the rules are disputed. Class A is currently exempt from establishment licensing altogether by gazetted exemption — a genuine and unusual relief, though its conditions and duration are in a scanned notice we could not read in full.
You, with usThree licences: manufacturer, distributor, wholesaler. A manufacturer licence covers manufacture, import, distribution and export. A distributor licence covers import, export and distribution. A wholesaler licence covers neither import nor export — a distinction that catches people who assume "wholesaler" is the safe generic choice.
Us, with youCovering letter, the application form in both spreadsheet and PDF, the representative's curriculum vitae, a quality manual for manufacturers and distributors or a site master file for wholesalers, proof of payment, the product list with international nomenclature codes, and evidence of pre-market approval from one of the six recognised jurisdictions.
You, assembled by usApplications go to SAHPRA electronically. Deficiencies come back as an observation letter with ten working days to respond, and a maximum of two cycles. Miss the second and the application ends — you start again, and pay again.
Representative, managed by usFive years, conditional on the annual retention fee each June. The regulation requires renewal at least 180 days before expiry; SAHPRA's own guidance says 90. A licence allowed to lapse is not renewed — you apply for a new one.
Shared — we run the calendarIf your device emits radiation, there is a second regulator inside the same building. X-ray equipment, linear accelerators, MRI and Class 3B and 4 lasers are licensed separately under the Hazardous Substances Act of 1973, by SAHPRA's own Radiation Control unit, on their own forms. SAHPRA's guidance on importing new X-ray equipment says in terms: refer also to the Medical Devices unit. Both regimes apply, and they do not share an application.
Fees are set by ministerial regulation rather than by the regulator, gazetted in February 2025 and effective the day after. SAHPRA republishes the device figures in its own licensing guidance, which is where these come from.
| Item | Fee, ZAR |
|---|---|
| Manufacturer licence — new application | 26,200 |
| Distributor licence — new application | 15,600 |
| Wholesaler licence — new application | 15,600 |
| Manufacturer licence — renewal | 22,900 |
| Distributor or wholesaler licence — renewal | 13,100 |
| Amendment application | 5,500 |
| Licence issuing | 3,500 |
| Annual retention, every June | 4,400 |
| Certificate of free sale, issued by SAHPRA | 1,460 |
| Notification, such as a product-list update | 0 |
From SAHPRA's licensing guidance version 4, dated 21 May 2025, which reproduces the schedule gazetted on 12 February 2025 and effective from 13 February 2025. The gazette itself is a scanned image without a text layer, so we cite SAHPRA's own restatement rather than claim to have read the annexure. There is no product registration fee, because there is no registration. Radiation licence fees are not published; a draft fee instrument for that regime went out for comment in August 2026.
The General Regulations require a renewal application at least 180 days before expiry. SAHPRA's own licensing guidance and its published questions and answers both say 90 days, and warn that a late application is not accepted at all — you must apply for a new licence. We would work to 180 and treat 90 as the administrative floor, because the cost of being wrong is a lapsed licence rather than a late one.
On turnaround, the same split. The guidance promises six to eight weeks. The performance target SAHPRA is actually held to, and reports against to Parliament, is eighty per cent of device establishment licence applications finalised within ninety working days. Budget the second number.
SAHPRA is phasing in a requirement that establishment licence holders hold ISO 13485:2016 certification from a conformity assessment body that SAHPRA itself recognises. From 1 June 2025 it has been required with renewals. SAHPRA aims to have verified every licence-holder's certificate by 1 April 2028.
Two consequences for a UK manufacturer, and the second is not obvious.
There is no unique device identification requirement in South Africa, and no device labelling guideline beyond the essential principles, which require information in English and permit any other South African language. A dedicated post-market surveillance and clinical follow-up guideline appeared for the first time in September 2025.
More than on any other page here, and for one reason: during 2026 SAHPRA moved its document library to a host that refuses automated access. We have the index — titles, document numbers, versions and dates — for everything below. We do not have the text.
SAHPGL-MD-22, version 1, 25 February 2026. Whether it adds the MHRA to the device recognition list is the single most important open question for a UK manufacturer on this page.
The roster would not render. Whether a UK body can issue the ISO 13485 certificate SAHPRA will accept is unverified, and the phase-in makes it material.
Published 31 March 2026. It is the nearest thing to a roadmap for whether and when device registration begins.
Both February 2025 gazettes are scanned images without a text layer. We can confirm the Class A exemption exists; we cannot state its conditions or whether it expires.
Same problem. Our figures come from SAHPRA's restatement of the schedule, not from the gazette.
Not published anywhere we could find. A draft instrument for that regime was out for comment in August 2026.
Two answers that are better than the reputation suggests, and one that is a diligence burden rather than a barrier.
Payment. South Africa operates exchange control through authorised dealer banks, and it does not stand between you and a bona fide payment for imported goods. The practical trap is documentary: an advance payment above R100,000 requires the bank to see the customs declaration within four months, confirming the goods actually arrived. Write your contract so your South African buyer can produce it.
Local content. Medical devices are not a designated sector with a minimum local content threshold — pharmaceuticals are, devices are not. But since January 2023 the national schedule no longer sets those goals: each buying entity sets its own specific goals in its own procurement policy. So the question moved from one national rule to every individual tender document. The Public Procurement Act of 2024 is enacted but not commenced, and its draft regulations were still out for comment in mid-2026.
Used equipment. If you are shipping refurbished or second-hand devices, an import permit is required — the control exists specifically to stop poor-quality used medical equipment, and used X-ray machines are named as the example. New devices are not generally subject to it.
On national health insurance, which will come up if your buyer is public sector: the Act was signed in May 2024, government agreed in February 2026 to delay proclamation of sections of it pending a Constitutional Court ruling, and no judgment had been delivered when we checked. Nothing official has been published about its effect on device procurement. Be careful with press coverage here — a Constitutional Court judgment of May 2026 that was widely reported as "the NHI judgment" in fact concerned certificates of need under a different Act.
The second-to-last question is the one nobody asks. An individual who already represents four other manufacturers is not necessarily wrong for you — but you should know it before you depend on them, not after.
The other half of this market
The answer inverts entirely. For medicines SAHPRA names the MHRA as a recognised regulatory authority, accepts a UK GMP certificate on the papers, and runs a registration system the UK government records as having cleared its backlog. The barrier moves downstream to price: one single exit price, set once, moved only by the Minister's annual percentage.
The medicines page for South Africa →
Everything about this market turns on who holds the licence, and the answer is a named human being. Send us the device and we will tell you what to ask of them, and what to write into the agreement.
Or reach us directly — mail@bcabusiness.co.uk · +44 7342 901002 · WhatsApp
This page carries more unread documents than any other on the site, and they are listed rather than glossed. The cause is a hosting change at SAHPRA during 2026 which blocks automated retrieval; the remedy is to request the documents directly, which is what we do for a client engagement. Re-checked quarterly, and immediately if a call-up notice for device registration is gazetted — which would change this page more than any other event we are watching.