Registering a Medical Device in South Africa: Steps, Regulations, and SAHPRA Approval
To register a medical device in South Africa, submit an application to SAHPRA. Appoint an Authorised Representative and pay the $1,010 establishment license fee. The process takes 6-8 weeks. Consult SAHPRA for guidance and ensure your device meets market compliance with local regulations before proceeding. Third, the entity must submit an application to the South … Read more