Craniotech
Stellenbosch, South Africa
Stellenbosch designer and manufacturer of patient-specific neurosurgical and maxillofacial implants and surgical guides since 2014.
Business types in Stellenbosch
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.