Product List and GMDN Codes: Notification versus Amendment under an MDEL

1. Key takeaways

Among the application materials for a South African Establishment Licence, the product list is the core attachment: the applicant must list all medical devices it manufactures, distributes or wholesales, and provide the nomenclature system code required by Notice 1515 Regulation 8(5)(b)(iv) (in practice, the GMDN code). The maintenance rules are: where a change does not affect the device categories already licensed to the entity, it can be handled by written notification free of charge; where a new device category is involved, a full amendment application must be filed with payment of fees.

Two further points anchor daily practice. First, the product list defines the substantive boundary of the licence: devices outside the list are not covered by it. Second, the list must stay synchronised with foreign approvals — where a product is relabeled or its name or kit composition changes, a full amendment is required, and regulatory conditions attached to the foreign approval declared to SAHPRA must continue to be met.

2. Legal basis

The table below lists the official sources relied upon.

3. Expert insights

Insight 1: The product list is the substantive boundary of the licence, not an administrative attachment. The authorities expressly require that all devices concerned be listed at application. This means the licence not only authorises the entity to carry on certain activities but also defines the range of devices the entity may handle. Devices outside the list are, in principle, not covered by the licence — which is exactly why a company must complete the list procedure before extending its catalogue. Treating the list as living regulatory infrastructure, rather than paperwork filed once, prevents the common situation where a commercially launched product has no regulatory cover.

Insight 2: List changes split into a notification route and an amendment route, with significantly different costs. A product list change that does not affect device categories follows the written notification route, free of charge; adding a device category requires a full amendment application with fees. This dividing line directly determines the maintenance cost of the licence, and it is also the economic reason for organising the list by device category rather than by SKU: a catalogue structured by category absorbs routine product additions through the free route, while a SKU-level list forces repeated amendment filings that cost money and management attention.

Insight 3: The nomenclature system code is the connecting key between the list and future registration. Regulation 8(5)(b)(iv) makes the nomenclature system code a mandatory field of the registration application form, and eligibility for the feasibility study likewise depends on whether the GMDN codes fall within the designated lists. This shows that the GMDN code is not merely an identifier: it is the organising basis by which SAHPRA calls up products in batches — an incorrect code can cause a product to be missed when a call-up notice is published. Codes should therefore be verified against the GMDN database at entry and re-verified whenever the list changes.

Insight 4: Repackaging and relabeling trigger a full amendment. The authorities state expressly that where the product name or kit composition changes, or the product is relabeled, a full amendment must be applied for with payment of fees; moreover, the regulatory conditions attached to the foreign market approval declared to SAHPRA must continue to be met. This bears directly on companies performing localised packaging: repackaging decisions that look purely commercial from a logistics perspective are regulatory events in South Africa, and the foreign approval conditions travelling with the product must be tracked on an ongoing basis.

Insight 5: The Phase 4 ISO 13485 requirement reaches product list updates as well. From 1 June 2027, notifications of product list updates must also be accompanied by an ISO 13485 certificate for verification. This means that after 2027, even the free list notification needs system certificate support — free of charge does not mean without threshold. Companies should plan certificate validity so that it covers not only renewals and amendments but also the routine list updates that keep the licence aligned with the commercial catalogue.

4. Practical recommendations

The following actions keep the product list compliant and maintainable.

1. Organise the list by device category: this lowers the frequency and cost of future amendments.
2. Enter the nomenclature system code accurately for every item: and update the codes whenever the list changes.
3. Distinguish the notification route from the amendment route: first determine whether any licensed category is affected.
4. Assess whether repackaging or relabeling triggers an amendment before acting.
5. Link the list with foreign approval status: changes in regulatory conditions must be synchronised.
6. Plan for the ISO 13485 certificate being required for list updates from June 2027: prepare early.

5. Verification checklist

Confirm every item below whenever the product list is created or changed.

• □ The product list states all devices concerned
• □ A nomenclature system code (GMDN) has been entered for every device
• □ The list structure is organised by device category
• □ It has been determined whether a list change follows the notification or the amendment route
• □ Repackaging and relabeling situations have been assessed for amendment triggers
• □ The list is maintained in sync with foreign registration status and regulatory conditions
• □ It is understood that from 2027-06 list updates must be accompanied by an ISO 13485 certificate
• □ The list version is consistent with the content of the licence certificate

Regulatory information verified as of 29 October 2026. The regulations, guidance and effective dates described in this article are limited to the official sources listed in the legal basis section above, 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 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 (English), and post-market vigilance and annual compliance information submission support.
• Contact: hito.lin@grzan.cn; website www.grzan.cn.