SAHPRA current fee schedule, reviewed for 2026, in ZAR.
7 fee lines100% exact amountscurrency ZARFX rates 2026-08-15reviewed 2026-08-14
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| New medical-device/IVD establishment licence - manufacturer | ZAR 26,200 | $1,619 | Per establishment licence | Verified |
| New medical-device/IVD establishment licence - distributor or wholesaler | ZAR 15,600 | $964 | Per establishment licence | Verified |
| Establishment-licence renewal - manufacturer | ZAR 22,900 | $1,415 | Per renewal | Verified |
| Establishment-licence renewal - distributor or wholesaler | ZAR 13,100 | $809 | Per renewal | Verified |
| Annual establishment-licence retention | ZAR 4,400 | $272 | Annual | Verified |
| Establishment-licence amendment | ZAR 5,500 | $340 | Per amendment | Verified |
| Approved licence issuance / collection | ZAR 3,500 | $216 | Per licence | 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; inspection and other regulatory charges are separate.
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Exact amounts verified against the SAHPRA fee schedule · full review 2026-08-14 · row IDs are stable — cite as government-fees:south-africa:new-establishment-licence-manufacturer