What steps are required to obtain an import permit for medical devices into South Africa under AfCFTA rules?

All importers or distributors of medical devices (especially class B-D) must hold a Medical Device Establishment license from SAHPRA. There are different license types depending on the medical device and certain eligiblity criteria that must be met. in short a SAHPRA license is required and customs clearance will be required via SARS. it is recommended that you engage with an attorney in south africa to assist you with the SAHPRA license, customs clearance, tarriff preferences, general compliance and custom disputes (if any).