Instructions for Use and Electronic IFU Requirements in South Africa

1. Key takeaways

South Africa splits its instructions for use requirements into two provisions by product attribute: Regulation 23 governs the instructions for use of medical devices (non-IVD), and Regulation 24 governs the instructions for use of IVDs; both are mandatory accompanying materials of the registration application (Regulation 8(3)(c)). On 8 May 2026, SAHPRA issued its communication on the Regulatory requirements for electronic instructions for use (e-IFU) of medical devices (MD03-2026/27), regulating the conditions under which instructions may be supplied in electronic form. The electronic IFU is an alternative means, not the default means, and its conditions of applicability must be confirmed case by case. Three points frame the topic. The two provisions exist separately because the content structure of a device IFU and an IVD IFU differ, with IVD instructions covering analytical performance, sample requirements, result interpretation and limitations. Like the label, the IFU is application material and must be finalised before submission. And whatever the medium, the language floor of Regulation 8(4) still applies: going electronic changes the carrier, not the content or language requirements, and companies must not simply transplant EU or US e-IFU practice into South Africa without checking MD03-2026/27.

2. Legal basis

3. Expert insights

Insight 1: The instructions for use of non-IVD devices and IVDs are set out in two separate provisions with different content structures. Regulation 23 and Regulation 24 are two independent provisions, which shows the legislator considered the content differences between the two product classes substantial enough to warrant separate treatment. An IVD IFU typically must also cover analytical performance, sample requirements, result interpretation and limitations, whereas the non-IVD structure revolves around indications, contraindications, warnings and operating steps. Companies preparing both device and diagnostic products for South Africa should therefore maintain two IFU templates rather than forcing one structure onto both, since reviewers expect the applicable provision’s content expectations to be visible in the document itself.

Insight 2: The instructions for use are application material and must be finalised in step with the label. Regulation 8(3)(c) lists the instructions for use among the materials that must accompany the application, alongside the label under item (b). This reinforces once again the requirement that the IFU be finalised before submission, and companies should schedule IFU localisation together with label localisation in the same front-loaded work package. Because the IFU content must agree with the label and with the dossier’s performance claims, translating and reviewing them as one set avoids the inconsistencies that arise when they are produced by separate workstreams at different times.

Insight 3: The e-IFU rule is new for 2026 and its conditions must be confirmed case by case. MD03-2026/27 (8 May 2026) is SAHPRA’s dedicated communication on electronic instructions for use. Practical estimate: the electronic form usually carries conditions, such as specific product categories, specific categories of users, and arrangements for providing a paper version on request, and companies should check the conditions of applicability in the communication case by case before deciding to adopt the e-IFU. It is not advisable to transplant the EU or US e-IFU experience directly, because the South African communication is recent and its scope of application is narrower than in more mature regimes.

Insight 4: The e-IFU does not exempt the language requirement. Even where the electronic form is adopted, the English floor of Regulation 8(4) still applies. Going electronic changes the carrier, not the content or the language requirements. The electronic document should therefore carry the same regulatory content as the paper version, in English at minimum, and the versioning of the electronic file should be managed with the same discipline as print artwork, so that the version a user downloads is always the version that was submitted and approved.

Insight 5: Changes to the IFU follow the same logic as label changes and trigger change management. A change of product name or kit composition, or re-labelling, requires a full change application; as a component of product information, major changes to the IFU should likewise be assessed for change management. Practical estimate: bring IFU versions into the change list, and assess whether a major revision needs to be declared to SAHPRA before it is implemented. This assessment step costs little and prevents the situation in which an approved application, the market label and the distributed IFU each describe a different version of the product.

4. Practical recommendations

1. Determine IVD versus non-IVD first, then apply Regulation 23 or Regulation 24 accordingly.
2. Finalise the IFU in step with the label: both are application material.
3. Before adopting the e-IFU, check the conditions of MD03-2026/27 case by case.
4. Do not let the electronic form lower the English and content requirements.
5. Bring IFU versions into change management: major revisions are assessed first.
6. Retain distribution and accessibility records for the IFU: for inspection and vigilance verification.

5. Verification checklist

• □ It has been determined whether Regulation 23 (non-IVD) or Regulation 24 (IVD) applies
• □ The IFU has been finalised before submission as application material (Regulation 8(3)(c))
• □ The IFU content is, at least, in English (Regulation 8(4))
• □ For intended e-IFU use, the conditions of MD03-2026/27 have been checked case by case
• □ It has been confirmed that the e-IFU does not exempt language and content requirements
• □ IFU versions have been brought into change management
• □ IFU distribution and accessibility records have been retained
• □ The IVD IFU covers analytical performance, sample requirements and result interpretation

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

• South Africa local resources: GRZAN assists manufacturers from the Chinese mainland and overseas with SAHPRA medical device establishment licence (MDEL) applications and product registration preparation, including authorised representative (AR) scheme design, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification determination, technical dossier preparation, and the setup of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A/B/C/D), establishment licence applications and renewals, reliance pathway justification, technical dossier and Essential Principles conformity argumentation, labelling and IFU localisation in English, and support for post-market vigilance and annual compliance information submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.