Question 1

What is a SAHPRA authorised representative?

Accepted Answer

An authorised representative acts as the mandated local liaison between a foreign medical device license manufacturer and SAHPRA, ensuring all imported devices comply with South African registrations.

Question 2

How long does medical device registration take in South Africa?

Accepted Answer

Timelines vary significantly based on the device's risk classification and the completeness of the submitted technical application. Partnering with an expert consultancy can drastically reduce unnecessary delays.

Question 3

Do I need a Quality Management System (QMS) to sell medical devices?

Accepted Answer

Yes. SAHPRA requires medical device manufacturers and distributors to implement and maintain a compliant QMS (such as ISO 13485) to ensure ongoing product safety and quality.