RUO and IUO Medical Devices in South Africa: SAHPRA MD01-2026/27 Boundaries

1. Key takeaways

On 25 June 2026 SAHPRA published the communication Regulatory Requirements for Research Use Only (RUO) and Investigational Use Only (IUO) Medical Devices (including IVDs) (MD01-2026/27). The core boundary is this: RUO/IUO products are not used in clinical diagnosis or treatment, and therefore circulate on a different track from marketed devices; the moment a manufacturer’s claims, labelling or manner of use point towards diagnostic or therapeutic purposes, the product ceases to be RUO/IUO and must be handled under the full device requirements.

2. Legal basis

3. Expert insights

Insight 1: The anchor for determining RUO/IUO status is intended use, which shares its source with the device definition. The device definition in Act No. 101 of 1965 is built on the manufacturer’s intended use, and SAHPGL-MD-04 v5 likewise makes classification depend on intended use. Consequently, a reagent labelled RUO whose promotional materials describe it as suitable for testing a particular disease has already had its intended use altered — it no longer qualifies as RUO, whatever its certificate or catalogue page says. Companies should therefore treat any statement of clinical purpose, in whatever medium it appears, as a regulatory act with consequences.

Insight 2: MD01-2026/27 was issued in 2026, showing this is a line newly drawn by SAHPRA. The communication is the first medical device communication SAHPRA published in 2026 (numbered MD01-2026/27). Its significance lies in bringing RUO/IUO products, previously in a grey zone, onto an explicit track — for companies this is both a constraint and a protection, since clear rules reduce the uncertainty that previously surrounded research products. For products already circulating as RUO, the communication now provides the reference point against which existing labelling and claims should be reviewed.

Insight 3: RUO/IUO and clinical trials are two different pathways. Products used in pre-market clinical studies follow the clinical trial pathway under Regulation 16; only products used in basic scientific research qualify as RUO. Confusing the two pathways leads either to research products being used without the required trial authorisation, or to unnecessary regulatory burdens being shouldered for genuinely non-clinical research, both of which are costly outcomes. A simple internal gate — asking whether the product will generate data used to support market access — separates the two populations cleanly.

Insight 4: The RUO risk is highest in the IVD field. The boundary between research and diagnosis is blurriest for testing reagents, and test results inherently carry diagnostic implications. Practical estimate: IVD companies should review labelling, instructions for use, websites and sales scripts for RUO products in a single unified pass, because a diagnostic claim appearing on any one channel is enough to invalidate the RUO characterisation across the board. Distributor training matters as much as head-office review, because sales conversations happen far from the person who drafted the label.

Insight 5: Moving from RUO to a marketed device is a complete compliance transition. Once a product leaves RUO status, it must be handled under the full device requirements: establishment licence, classification, labelling and instructions for use, and essential principles conformity, with product registration under future call-up notices still to come. Companies should manage the transition from RUO to commercialisation as an independent project milestone, not as a mere labelling edit, because every stage of the compliance chain must be re-run. Planning the transition early also protects continuity of supply for existing research customers while the commercial file is built.

4. Practical recommendations

1. Review claims for RUO/IUO products channel by channel: labelling, instructions for use, website, sales scripts.
2. Clearly separate RUO products from clinical trial products: each follows its own pathway.
3. IVD companies should focus on diagnostic claims: this is where characterisation most often fails.
4. Set the transition from RUO to commercialisation as an independent project milestone: re-run the full compliance process.
5. Keep internal determination records of product use: available to explain at inspections.
6. Track subsequent revisions of MD01-2026/27.

5. Verification checklist

• □ Current text of MD01-2026/27 (2026-06-25) obtained
• □ Determined item by item, on intended use, whether products qualify as RUO/IUO
• □ Labelling, instructions for use, website and sales scripts reviewed with no diagnostic claims
• □ RUO products distinguished from clinical trial products governed by Regulation 16
• □ Diagnostic claims reviewed with priority for IVD products (practical estimate)
• □ Transition from RUO to commercialisation set as an independent project milestone
• □ Internal determination records of product use retained
• □ Subsequent revisions of MD01-2026/27 added to the monitoring list

Regulatory information verified as at 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the content published by the official sources listed under Legal basis as at that date; where official documents have been updated, the latest published version prevails.

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