Afrimedics
Johannesburg, South Africa
Johannesburg supplier of medical equipment such as suction units, examination lamps and theatre stands, with a Cape Town branch.
Akacia Medical
South Africa
South African healthcare group manufacturing CliniSut surgical wound closure products and distributing medical and surgical devices.
Anstem Medical
Pretoria, South Africa
Pretoria supplier of orthopaedic and sports medicine soft-tissue repair devices sourced from international suppliers.
Craniotech
Stellenbosch, South Africa
Stellenbosch designer and manufacturer of patient-specific neurosurgical and maxillofacial implants and surgical guides since 2014.
Heritage Surgical Products
Sandton, South Africa
Johannesburg ISO 13485 manufacturer of irrigation systems, drainage bags and disposables, licensed to import and manufacture devices.
Instrumental Healthcare
South Africa
South African supplier of surgical instruments, surgical equipment and wound care solutions to hospitals and units.
Intamed
Sandton, South Africa
Sandton distributor of medical equipment and consumables for surgical theatres and aesthetic medicine.
Intermed Medical Equipment
Cape Town, South Africa
Cape Town medical equipment supplier and exclusive authorised distributor, operating since 1987.
Logan Medical & Surgical
Durban, South Africa
Durban manufacturer, importer and distributor of surgical gowns, drapes, swabs and other surgical supplies, established 2003.
Medequip
Edenvale, South Africa
Edenvale importer and distributor of ophthalmic and surgical devices, including Rudolf and Swann-Morton, established in 1980.
Medhold Medical
Kempton Park, South Africa
Kempton Park supplier of medical devices, equipment and clinical solutions from international manufacturers since 1988.
Medi-Safe Surgicals
South Africa
South African manufacturer of surgical safety scalpel solutions.
Megadent
Cape Town, South Africa
Cape Town importer of dental consumable brands supplied exclusively for Southern Africa.
Multisurge
South Africa
South African manufacturer, importer and distributor of medical and surgical disposables, established in 1997.
Osta Biomaterials
Benoni, South Africa
Benoni SAHPRA-licensed manufacturer of biomaterials for bone grafting and tissue regeneration.
Sanjmed Medical Distributors
Johannesburg, South Africa
Johannesburg distributor of surgical instruments, clinic equipment, hospital furniture and consumables in Southern Africa.
Specmed Medical
Midrand, South Africa
Midrand importer and distributor of medical equipment and surgical instruments with more than 30 years of supply history.
TiTaMED
Cape Town, South Africa
Cape Town OEM manufacturer of custom and modular titanium orthopaedic implants and a spinal system, established in 1996.
Werkomed
Johannesburg, South Africa
South African supplier and exclusive distributor of medical gloves, surgical instruments and orthopaedic trauma products since 1994.
Business types in South Africa
Cities in South Africa
Regulation in South Africa
Regulator: South African Health Products Regulatory Authority (SAHPRA)
South Africa currently regulates devices mainly through SAHPRA establishment licences; product registration is planned but not yet called up.
From the sourced SAHPRA entry, checked 29 October 2026. General information, not legal advice. Requirements for South Africa · All medical certifications
Frequently asked questions
Are reusable surgical instruments exempt from SAHPRA licensing?
Often, if supplied non-sterile. SAHPRA's classification guideline (SAHPGL-MD-04) names scissors, artery forceps, tissue forceps, clamps, osteotomes and chisels as Class A reusable surgical instruments. SAHPRA licenses are required for manufacturers, distributors and wholesalers of Class B to D devices and of sterile or measuring Class A devices, so dealers in non-sterile Class A instruments may fall under the Class A exemption.
Supplying the same instruments sterile removes the exemption, and single-use or other transient surgically invasive devices are generally higher than Class A. Check the exemption against the dealer's full product range. See the medical certifications page.
Does a supplier need a SAHPRA license to bid for South African public tenders?
Yes. SAHPRA states that a valid license is required to bid for national and provincial tenders, and since 31 March 2020, acknowledgement letters are no longer accepted in place of a license. A distributor bidding for public-sector contracts should therefore hold the right establishment license for the device classes involved.
When partnering with a South African distributor, ask for its SAHPRA license number and scope, its authorized representative and its ISO 13485 status. The directory currently lists more than 15 companies in South Africa, with city pages such as Johannesburg, Cape Town and Sandton; see the South Africa country page.
What is the difference between SAHPRA manufacturer, distributor and wholesaler licenses?
SAHPRA establishment licenses cover different activities:
- Manufacturer license: manufacture, pack, label, service, import, export and distribute.
- Distributor license: import, export and distribute.
- Wholesaler license: buy locally and sell to retailers, with no import or export.
Each licensed establishment needs an authorized representative, who must be a natural person based in South Africa, and a quality management system. Manufacturers and distributors need an ISO 13485:2016 certificate from an accredited body at license renewal. For Class C and D devices, the licensing guideline asks for evidence of approval by a recognized foreign regulator. See the South Africa country page.