South Africa Medical Device Establishment Licence Official Fee Schedule Explained

1. Key takeaways

South Africa charges fees for medical device establishment licences under the same fee structure as pharmaceutical establishment licences, as SAHPRA states officially, and all amounts are denominated in South African Rand (R). The widely cited current schedule is as follows: for a new application, a manufacturer pays R25 200, while a distributor, wholesaler, importer or exporter pays R15 000 for each category. For renewal after five years, a manufacturer pays R22 000, a distributor or wholesaler R12 600, and an importer or exporter R9 200. The annual retention fee is R4 200 for every licence category. The amendment fee is R5 300 for every category, and the licence issuance fee, payable after approval and before the licence is issued, is R3 400 for every category. Note that SAHPRA may adjust the fee schedule annually, so the amounts actually payable must always be confirmed against the fee schedule in force.

2. Legal basis

3. Expert insights

Insight 1: South Africa borrows the pharmaceutical fee structure for devices, which is a transitional arrangement. SAHPRA officially states that the current pharmaceutical establishment licence fee structure applies to medical device establishment licences. This explains why device fees are divided by manufacturing, distribution, wholesaling, importing and exporting rather than by device risk class — the structure was never designed for devices in the first place. Companies building long-term budgets should therefore expect that once product registration is fully implemented, the fee structure is likely to be restructured, and historical figures should be treated as planning inputs rather than fixed commitments.

Insight 2: The fee gap between manufacturers and distributors is close to seventy per cent. The new application fee is R25 200 versus R15 000, and the renewal fee is R22 000 versus R12 600. The gap itself is a pricing signal for whether manufacturing activity takes place in South Africa. When choosing the establishment role, fees should remain a secondary consideration, because the decisive factor is the actual scope of activities performed — no entity should misstate its licence type in order to save fees, since operating outside the licensed scope is a compliance breach in its own right.

Insight 3: The annual retention fee is the most easily overlooked recurring cost. It stands at R4 200 per year and remains payable even in the renewal year, because the Medicines Act does not allow a renewal exemption. Over a five-year cycle this is a five-time payment, not a four-time one, so a five-year budget must be built on five payments rather than four, on top of the renewal fee itself.

Insight 4: The licence issuance fee is a fourth official charge that is frequently omitted. In addition to the new application fee, the annual retention fee and the amendment fee, R3 400 becomes payable after approval and before the licence is issued. The real official outlay for one application equals the application fee plus the issuance fee, yet first-year cost calculations often count only the former, leaving companies with an unexpected invoice at the finishing line.

Insight 5: Fees are adjusted annually, and increases have already been discussed. In the fee regulations review published in February 2024, SAHPRA discussed raising the manufacturer new application fee from R25 200 to R26 200 and the distributor fee from R15 000 to R15 600. This demonstrates that the fees are not fixed — budgets compiled from historical amounts carry deviation risk, and the current fee schedule must be re-checked before any filing.

4. Practical recommendations

1. Budget on the combined total of the application fee, the licence issuance fee and the annual retention fee: never plan on the application fee alone.
2. Count the retention fee in the renewal year as well: a five-year cycle means five payments, not four.
3. Re-check the current SAHPRA fee schedule before filing: fees are adjusted annually.
4. Select the licence type according to actual activities: the fee difference must not influence the classification decision.
5. Keep an exchange-rate buffer: fees are denominated in Rand, so home-currency costs move with the exchange rate.
6. Retain every payment record: payment references must include the applicant name and the application number.

5. Verification checklist

• □ New application fee confirmed by licence type (manufacturer R25 200 / other categories R15 000)
• □ Licence issuance fee of R3 400 included (payable after approval and before issue)
• □ Annual retention fee included at R4 200 per year, including the renewal year
• □ Amendment fee of R5 300 built into the change budget
• □ Renewal fee confirmed by type (manufacturer R22 000 / distributor and wholesaler R12 600 / importer and exporter R9 200)
• □ Current SAHPRA fee schedule re-checked before filing
• □ Exchange-rate buffer reserved
• □ Payment records and payment references retained in full

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.