SAHPRA’s Friday deadline: why companies should, and should not, join the device-registration test

South Africa’s medicines regulator has given medical-device companies until 16:30 on Friday 18 September 2026 to volunteer for Phase 2 of the SAHPRA medical device registration voluntary feasibility study.

The study is not a new law, a product registration, or a call-up notice. SAHPRA wants licence holders to walk through a future registration process so the Authority can see what works before it makes product registration mandatory. An addendum published on 9 September extended the expression-of-interest window and reopened the door to products left out of the first Phase 2 invite.

The policy story is larger. SAHPRA is designing a product-registration system while it separately sends revised Medical Devices Regulations through an independent expert review. Those draft regulations, not Friday’s form, are what will eventually replace the 2016 rules.

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SAHPRA medical device registration: what Friday is, and is not

South Africa still regulates devices mainly through establishment licences. A company may manufacture, import, distribute or wholesale if it holds the right licence. Individual products do not yet carry a SAHPRA registration number. Section 14 of the Medicines Act only bites after the Authority issues a call-up notice for specified devices or classes. No such notice is in force.

Phase 2 tests the missing layer. SAHPRA has said it is looking for:

• holders of a valid medical-device establishment licence (manufacturers and distributors)
• human-use devices and IVDs
• oncology products linked to breast, prostate and lung cancer
• mainly Class C and D
• only devices whose GMDN codes appear on the EOI list, about 60 products in the original scoping
• products already on the South African market, or not yet imported or made locally

Participation is voluntary. There is no application fee. Acceptance is at SAHPRA’s discretion, and capacity is limited. The study is scheduled to run into late 2027, with an outcome report afterwards. Draft guidelines and templates issued with the EOI are the versions participants must use, not older Phase 1 packs.

Phase 1, launched in May 2024 around HIV and TB diagnostics and devices, showed why a second round exists. SAHPRA targeted 32 products, received about 22, lost some to withdrawal or exclusion, and later reported that a reliance route had moved a handful of files. Officials said the first study did not give them everything they needed on fee structure and timelines. Phase 2 is the second attempt.

Why participate

You get a rehearsal before the exam is compulsory. When a call-up notice arrives, the companies that have already assembled a technical file, mapped GMDN codes, classified the device under SAHPGL-MD-04, and answered SAHPRA queries will move faster than those starting from a licence annexure and a brochure. Phase 2 is one of the few legal ways to pressure-test that file against the process SAHPRA intends to use.

You see the live process, not the slide deck. Webinars describe portals, table of contents, reliance packages and query cycles. Sitting inside the study is different. Participants get an acceptance letter, portal training, and a working relationship with the Medical Devices Unit while the rules are still draft. That intelligence is hard to buy later.

You can influence the operating system. SAHPRA has been explicit that the study is how it validates process. Phase 1’s thin dossier flow is why fee and timeline design is still open. Companies that submit complete files, then document where the process stalled, give the regulator usable data. Sitting out means the system will be built from whoever does show up.

Oncology is a serious first market, not a side test. Breast, prostate and lung cancer products sit at the centre of public-sector diagnostics and treatment. If registration is later called up by risk class and disease area, these codes are plausible early candidates. Being in the feasibility cohort does not grant a registration number. It does put your file in the room where the process is being designed.

Why not participate

It is not authorisation. Nothing about an EOI, an acceptance letter or a completed feasibility file legalises a product that is not already lawfully on the market under an establishment licence. Do not treat Friday as a shortcut around licensing, ISO 13485 verification, or a future call-up.

The product list is narrow. If your catalogue is Class A/B consumables, cardiology, orthopaedics, wound care, or anything whose GMDN code is not on the EOI list, you will be refused. Stretching a borderline oncology claim to get in wastes both sides’ time.

The workload is real and unpaid. A registration-style file is not a licence product list. Expect classification justification, essential principles and technical documentation, clinical evaluation thinking aligned with SAHPGL-MD-16, QMS evidence, labelling and IFU, and query cycles. Phase 1 already saw withdrawals. If regulatory headcount is already consumed by licence renewals, ISO 13485 Phase 3 verification, and PMS, volunteering can slip from strategic to the file that never ships.

Confidentiality and capacity cut both ways. You will hand SAHPRA a detailed technical picture of a high-risk product. The Authority will treat the work as a study, not a marketing authorisation. If your concern is disclosing strategy, clinical gaps or a thin CER before the legal duty exists, that is a rational reason to wait, provided you are honest that waiting means doing the same work later under a deadline you do not control.

A practical way to decide before Friday

Ask five questions. If you cannot answer yes to the first three, stop.

1. Do we hold a current SAHPRA medical-device establishment licence as manufacturer or distributor?
2. Is the candidate a human-use oncology device or IVD for breast, prostate or lung cancer, with a GMDN code on the Phase 2 list, including codes the addendum has now opened?
3. Can we name an authorised person who will own queries for months, not days?
4. Do we already have, or can we assemble in weeks, classification, intended purpose, IFU, QMS evidence and a clinical-evaluation story that would survive SAHPGL-MD-16?
5. Is our goal to learn the process, or do we think this is a registration?

If the answer to question five is registration, do not apply. If one through four are yes and five is learn the process, apply.

New-to-market products are allowed in the study design. That is useful for companies planning a first South African launch in oncology diagnostics or devices. It is a poor fit for a speculative SKU with no IFU and no QMS trail.

The deadline is small, the direction of travel is not

Friday decides who is inside the second test cohort. It does not decide whether South Africa will register medical devices.

That decision is already visible in the architecture SAHPRA has built since 2024: ISO 13485 phased in through 2028, a reliance guideline (SAHPGL-MD-22), clinical evaluation and investigation guidelines, PMS and PMCF guidance, an FSCA guideline out for comment until 31 October, and draft regulations close enough to final that the Authority hired outside experts to stress-test them.

Companies that skip Friday are not non-compliant. They are choosing to meet the same process later, when it is no longer voluntary. Companies that apply should do it with a complete file and a clear internal brief: this is a laboratory, not a licence.