SAHPRA current fee schedule, reviewed for 2026, in ZAR.
11 fee lines100% exact amountscurrency ZARFX rates 2026-09-28reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| New medical-device/IVD establishment licence - manufacturer | ZAR 26,200 | $1,605 | Per establishment licence | Verified |
| New medical-device/IVD establishment licence - distributor or wholesaler | ZAR 15,600 | $956 | Per establishment licence | Verified |
| Establishment-licence renewal - manufacturer | ZAR 22,900 | $1,403 | Per renewal | Verified |
| Establishment-licence renewal - distributor | ZAR 13,160 | $806 | Per renewal | Verified |
| Establishment-licence renewal - wholesaler | ZAR 13,100 | $803 | Per renewal | Verified |
| Annual establishment-licence retention | ZAR 4,400 | $270 | Annual, by the last working day of June | Verified |
| Establishment-licence amendment | ZAR 5,500 | $337 | Per amendment | Verified |
| Approved licence issuance / collection | ZAR 3,500 | $214 | Per licence | Verified |
| Certificate of Free Sale | ZAR 1,460 | $89.45 | Per certificate | Verified |
| Clinical-trial application - safety and efficacy, including devices/IVDs | ZAR 33,700 | $2,065 | Per application | Verified |
| Inspection charge-out rate | ZAR 1,660 | $102 | Per hour, per inspector | Verified |
Government fees only — service and testing costs are separate- These are establishment-licensing charges, not a universal per-product registration tariff.
- South Africa’s device product-registration framework remains route-dependent.
- Fees are set by GG 52106 GN 5856 of 12 February 2025: the new-licence row is R26,200 for a manufacturer licence and R15,600 for a distributor or wholesale licence.
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Exact amounts verified against the SAHPRA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:south-africa:new-establishment-licence-manufacturer