Licence Amendment versus Product List Update Notification: SAHPRA MD10 and MD09

1. Key takeaways

South Africa separates two post-licence actions into two distinct procedures: a licence amendment (Amendment) is governed by MD10-2025/26 (27 January 2026) and attracts an amendment fee (R5 300, industry reference value), whereas a Notification of an Update to the Product List is governed by MD09-2025/26 (27 January 2026) and, where the change does not affect the device categories already licensed, is handled by written notification free of charge. There is only one dividing line: whether the change alters any device category already covered by this establishment’s licence.

2. Legal basis

3. Expert insights

Insight 1: The dividing line between the two procedures is the category, not the quantity. As long as a change does not affect the device categories already licensed, any number of individual products may be added through a notification that is free of charge; the moment a new device category is added, a full amendment with payment becomes mandatory. The economic implication is unambiguous: organising the product list by category is the optimal strategy. Companies should structure their licence portfolio so that free notifications cover as much of their commercial activity as possible.

Insight 2: Repackaging and relabelling are explicitly assigned to the amendment route. SAHPRA states that where the product name or kit composition changes, or where the product is relabeled, a full amendment with payment must be applied for; moreover, the regulatory conditions attached to the foreign market approvals declared to SAHPRA must continue to be met. This brings local packaging operations squarely into change management, and companies from the Chinese mainland frequently cross the line at exactly this point when adapting kits for local distribution.

Insight 3: From June 2027, even the free product list notification requires an ISO 13485 certificate. The scope of Phase 4 explicitly includes amendments to a valid medical device establishment licence as well as changes to the product list (notifications). This means that free of charge does not mean without prerequisites — after 1 June 2027, every product list update notification must be supported by a quality management system certificate, so certificate maintenance becomes part of routine list management.

Insight 4: Amendments and product list updates sit in the same phase of the ISO 13485 roadmap. Phase 4 treats the two side by side, which shows that SAHPRA regards them as the same kind of change to an existing licence. Companies can therefore manage both under a single internal approval logic, distinguishing them only at the point of external submission, where the question of whether a fee applies is decided.

Insight 5: Repackaged products must still comply with South African labelling requirements. SAHPRA explicitly notes that South African labelling requirements must be observed even where the product has been repackaged and registered in another jurisdiction. This is an easily missed layered requirement — compliance abroad never substitutes for local labelling compliance, and the labelling of repackaged stock should be reviewed against South African expectations before release.

4. Practical recommendations

1. First determine whether a category changes: this decides between the notification route and the amendment route.
2. Organise the product list by category: maximise the scope of the free notification route.
3. Assess amendment triggers before any repackaging or relabelling.
4. Prepare ISO 13485 certificates for list notifications too from June 2027.
5. Check South African labelling requirements after any offshore repackaging.
6. Keep records of every notification and amendment: they will be cited at renewal and during inspections.

5. Verification checklist

• □ Determined whether MD09 (notification) or MD10 (amendment) applies to this change
• □ Confirmed whether the change alters any device category already licensed
• □ Product list organised by category to widen the free notification scope
• □ Amendment trigger assessed for repackaging or relabelling scenarios
• □ Awareness confirmed that from 2027-06-01 list notifications also require an ISO 13485 certificate
• □ South African labelling requirements checked after offshore repackaging
• □ Amendment fee of R5 300 included in the budget (industry reference value)
• □ Records of every notification and amendment archived

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.

• South Africa local resource: GRZAN can assist manufacturers from the Chinese mainland and overseas in engaging the South African Health Products Regulatory Authority (SAHPRA) on medical device establishment licence (MDEL) applications and product registration preparation, including authorised representative (AR) scheme design, ISO 13485 certification route planning and CAB selection, GMDN coding and classification determination, technical documentation preparation, and the establishment of vigilance and adverse event reporting mechanisms.
• Service capabilities: product attribute determination and risk classification (Class A/B/C/D), establishment licence application and renewal, reliance pathway justification, technical documentation and essential principles conformity argumentation, labelling and instructions-for-use localisation in English, and post-market vigilance and annual compliance information submission support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.