SAHPRA · Medical device licence · SARS customs
South Africa is the most developed medical-device market on the continent. Devices are regulated by the South African Health Products Regulatory Authority (SAHPRA) under the Medicines and Related Substances Act, with customs administered by SARS.
Any entity that imports or distributes medical devices in South Africa must hold a SAHPRA Medical Device Establishment Licence. This licence is held by your importing/distributing company, not the overseas supplier. SWIFTSKY supplies the manufacturer evidence needed for device listing and import.
Typical documentation required from SWIFTSKY per product line:
Honest timeline note: The importer must hold a valid SAHPRA establishment licence before importing. Obtaining that licence can take several months. Device listing requirements vary by risk class. We supply all manufacturer documentation; licensing sits with the buyer.
SAHPRA applies a risk-based classification (Class A–D) aligned with global GHTF/IMDRF principles. Most disposables we export are low-risk (Class A/B), which simplifies the listing pathway. We help match each product to its likely class with supporting documentation.
| Item | Rate | Notes |
|---|---|---|
| Import duty — medical devices (general) | 0–10% | SACU tariff; many medical items are duty-free |
| VAT | 15% | On customs value + duty |
| Port / clearance charges | Variable | Confirm with your clearing agent |
Rates are indicative. Verify current HS codes and rates with a licensed South African customs clearing agent before importing.
We supply the full manufacturer documentation pack for your SAHPRA listing. You handle the licence; we handle the supply chain.