Labelling Requirements under Regulation 22 for South African Medical Devices and IVDs

1. Key takeaways

The labelling of medical devices in South Africa is governed by Notice 1515 Regulation 22 (Labelling of medical device or IVD), while the accompanying information of the registration application must, per Regulation 8(4), at least, be in English. The registration application must also submit the label intended to be used (Regulation 8(3)(b)) and the instructions for use (Regulation 8(3)(c)) as application material. English is the only mandatory language threshold in South Africa, which differs from Macao, China, where any one of Chinese, Portuguese or English may be chosen, and from some French-speaking African markets. The consequences for programme planning are concrete. Labelling is application material, so label design must be finalised before submission rather than after authorisation. Re-labelling is not a mere packaging action: SAHPRA makes clear that a change of product name or kit composition, or re-labelling of the product, requires a full change application with payment of fees, and that the regulatory conditions attached to the foreign market approval declared to SAHPRA must continue to be met. Finally, the reliance pathway does not exempt labelling localisation: even where FDA or CE approvals support the application, the label for the South African market must meet local requirements in its own right.

2. Legal basis

3. Expert insights

Insight 1: The phrase at least, be in English sets a cumulative floor, not a ceiling. Regulation 8(4) states that the submission information must at least be in English. This means English is a necessary condition, and SAHPRA or the market may require additional languages where needed. In practice, products aimed at the public healthcare system often need to consider wording in other official South African languages, but English is always the layer that cannot be missing. Companies should treat any additional language as an addition to a complete English base, not as a replacement, so that the English version remains the controlling text for review and for vigilance communication.

Insight 2: The label is application material, not a supplement submitted after approval. Regulation 8(3)(b) requires the application to include the label intended to be used on the device. This means label design must be finalised before submission, rather than following the pattern of obtaining the licence first and settling the packaging later. Companies should schedule label localisation ahead of the submission date, with translation, regulatory review and artwork proofing built into the project plan. A late label commonly delays an otherwise complete dossier, because the application cannot be filed without the label it must contain.

Insight 3: Re-labelling triggers a full change. SAHPRA makes clear that where the product name or kit composition changes, or the product is re-labelled, a full change application must be submitted with payment of fees, and the regulatory conditions attached to the foreign market approval declared to SAHPRA must continue to be met. This upgrades labelling from a packaging action to a compliance event, a point manufacturers from the Chinese mainland often underestimate. Any marketing decision to refresh artwork, move claims or change pack configuration should therefore be screened against MD10-2025/26 before execution, not after the stock has been printed.

Insight 4: Label and authorised representative information must be consistent. The authorised representative (AR) is a recorded item of the licence and the registration, with one AR per site. Practical estimate: the AR information printed on the label should match what is recorded in the licence and registration documents; after a site change or a change of AR, the label must be updated in step, otherwise the inconsistency constitutes a deficiency. Companies should link label artwork reviews to the licence register, so that every artwork revision verifies the AR block against the current licence record before release.

Insight 5: The reliance pathway does not exempt labelling localisation. Even where the product already holds FDA or CE approvals and the review conclusions can be relied upon, the label for the South African market must still meet local requirements. This is one of the most typical non-reliance items under the reliance pathway, and it should be prepared separately in the dossier. The local label, in English, aligned with Regulation 22 and consistent with the foreign approval’s conditions, is the deliverable that demonstrates this item has been handled rather than assumed away.

4. Practical recommendations

1. Finalise the label before submission: it is application material (Regulation 8(3)(b)).
2. Treat English as the non-negotiable floor: and assess whether additional languages are needed.
3. Assess change triggers before any re-labelling: MD10-2025/26.
4. Keep the AR information on the label consistent with the licence.
5. Prepare the South African label separately even under the reliance pathway.
6. Bring label versions into change management: any change is updated in step.

5. Verification checklist

• □ The label has been finalised before submission as application material (Regulation 8(3)(b))
• □ All submission information and label information are, at least, in English (Regulation 8(4))
• □ The mandatory content has been checked item by item against Regulation 22
• □ It has been assessed whether re-labelling triggers a full change (MD10-2025/26)
• □ The authorised representative information on the label is consistent with the licence documents
• □ A South African localised label has been prepared separately under the reliance pathway
• □ Label versions have been brought into the change management process
• □ The regulatory conditions attached to the foreign market approval continue to be met in the label

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.