SAHPRA licenses

Navigating the complexities of obtaining a SAHPRA license can be tedious. Whether you are looking for a SAHPRA license to import or export IVD’s or medical devices, we can handle your application.

Medical personal protective equipment (PPE) can only be legally imported, distributed or sold by medical device establishment holders. 

SAHPRA provides three types of medical device establishment licenses:

Manufacturer (manufacture, pack, label, service, import, export)

Distributor (import, export, distribute)

Wholesaler (storage, transportation, delivery)

Companies that both manufacture and wholesale medical devices, apply for both types of licenses.

SAHPRA requires companies applying for medical devices establishment licenses to provide a considerable amount of information on the company and the medical devices it will market. We guide you through out the process.