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

Question

I'm planning to import a medical device for distribution in South Africa and want to understand the regulatory and customs steps. Which authorities issue import licenses, what conformity assessments are required, and how AfCFTA tariff preferences affect duties and VAT? Would you recommend engaging a local attorney to ensure compliance and avoid penalties or delays?

RC Attorneys · Accepted Answer

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).

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

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