Establishment Licence Types: Manufacturer, Distributor and Wholesaler

1. Key takeaways

The South African Medical Device Establishment Licence (MDEL) is issued under Section 22C(1)(b) of the Medicines and Related Substances Act and comes in three types: the manufacturer licence (covering manufacture, packaging, labelling, servicing, import and export), the distributor licence (covering import, export and distribution), and the wholesaler licence (covering storage, transport and delivery). The only criterion for determining which licence applies is the activity actually performed within South Africa, not the company’s trade registration name or its position within the corporate group. A single company may need two or more licence types at the same time. Getting this determination right at the outset avoids the twin costs of rejected applications and fee differentials, and it frames every other obligation that follows, from ISO 13485 expectations to Authorised Representative staffing. The licence scope is also the first thing SAHPRA inspectors reconcile against what the site is actually doing, so the declared activities must match operational reality on the ground.

2. Legal basis

3. Expert insights

Insight one: the manufacturer licence means far more than production. In the official definition, the manufacturer licence covers manufacture, packaging, labelling, servicing, import and export. This means that a South African company that only relabels products, or only performs after-sales servicing, also requires a manufacturer licence, and this is the point most easily misjudged by companies from the Chinese mainland. Many businesses assume that warehousing and delivery alone are enough, only to discover that because they performed relabelling locally they have fallen into the manufacturer category. The activity lists in sections 6.21, 6.22 and 6.26 of form GLF-MD-06A v5 should be read line by line before any application is drafted.

Insight two: the dividing line between distributor and wholesaler is whether the flow of title changes. Distributors cover import, export and distribution; wholesalers cover storage, transport and delivery. The overlap lies in transport and storage, and the decisive test is whether the company undertakes the import or export leg. Practical estimate: a company that both imports and performs local warehousing and delivery should map its own activity list item by item and, where necessary, confirm the licence combination with SAHPRA, rather than choosing one licence on the basis of habit or convenience.

Insight three: licence type determines the intensity of ISO 13485 expectations. In SAHPRA’s five-phase ISO 13485 requirements document, the obligated parties are described as manufacturers and distributors (importers). Wholesalers are not at the core of that formulation; this is not an exemption but an indication that the requirement focuses on manufacturing and import activities. Companies should determine, by their own licence type, which category of obligated party they occupy in each phase, and document that determination so that auditors and inspectors see a consistent position across submissions.

Insight four: licence type is directly linked to fees. The new application fee for a manufacturer licence is significantly higher than for distributor and wholesaler licences, and renewal fees are likewise tiered. Selecting the wrong application type not only triggers a correction request but also creates fee shortfalls and schedule losses. Practical estimate: fees are governed by SAHPRA’s current fee schedule and may be adjusted annually, so the schedule should be checked immediately before payment rather than at project kickoff.

Insight five: one licence can cover multiple premises, but the Authorised Representative must be one per premises. The licence application must list the premises; the Authorised Representative (AR) requirement is one AR for each premises at which business is conducted. Premise count therefore directly determines AR staffing costs, and this is the line item most often omitted from budgets by multi-warehouse operators. It should be quantified before the application is filed, not discovered during the correction cycle.

4. Practical recommendations

1. Map actual activities item by item; do not infer the licence type from the company name.
2. Assess any labelling, packaging or servicing activity as a manufacturer licence.
3. Evaluate a licence combination for multi-activity companies: never default to the assumption that one licence suffices.
4. Anticipate ISO 13485 phase obligations by licence type.
5. Staff Authorised Representatives by premise count: one per premises is a hard requirement.
6. Check the current fee schedule before applying: fees are tiered by type and adjusted annually.

5. Verification checklist

• □ Verify that all actual activities of the company within South Africa have been listed item by item
• □ Verify the required licence type by activity (manufacturer, distributor, wholesaler)
• □ Verify whether labelling, packaging or servicing is involved (triggering the manufacturer licence)
• □ Verify whether import or export is involved (triggering the distributor licence)
• □ Verify the premise count and the corresponding Authorised Representative configuration
• □ Verify the current fee schedule against the licence type
• □ Verify the applicability of each ISO 13485 phase to the licence type
• □ Verify that the current application form version has been obtained (GLF-MD-06A)

Regulatory information verified as of 29 October 2026. The instruments, guidelines and effective dates described in this article are limited to the content published by the official sources listed under the legal basis above as at that date; where official documents are updated, the latest published version prevails.

• South Africa local support: GRZAN assists manufacturers in the Chinese mainland and abroad with SAHPRA Medical Device Establishment Licence (MDEL) applications and product registration preparation, including Authorised Representative (AR) arrangements, ISO 13485 certification pathway planning and CAB selection, GMDN coding and classification decisions, technical documentation, 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 arguments, technical documentation and essential principles conformity arguments, labelling and instructions for use localisation in English, and post-market vigilance and annual compliance submissions.
• Contact: info@grzanglobal.com; hito.lin@grzan.cn; website www.grzan.cn.