REGULATORY AUTHORITY: South African Health Products Regulatory Authority (SAHPRA)
CLASSIFICATION SYSTEM: Medical Device and IVD: A/B/C/D
- 6-8 weeks (regular pathway based on the actual experience)
- 10-15 working days (official published timeline for expedited regulatory pathway during COVID-19 pandemic)
Radiation Control License – 30 days (official published timeline)
SPECIAL REQUIREMENTS: Local testing is not required. However, additional license might be required for electronic products listed in the Schedule for Listed Electronic Products Regulation R1302 of 1991.
No overseas inspection is required. However, the foreign manufacturers must demonstrate that they are compliance with the conformity assessment requirements of the MDACS.
LOCAL FEES (New Application):
SAHPRA License – Initial Registration (including radiation control license if applicable): USD 1010.
SAHPRA License – Annual Fee: USD 282
LOCAL FEES (Manufacturer): No local fees are required. However, in addition to the SAHPRA license, the establishment must have a dedicated and registered facility to store the medical device, and list down all devices that they are dealing with including its GMDN codes.
LICENSE VALIDITY: The SAHPRA license is valid for 5 years. However, annual fee must be paid along with the proof that documentation used for the initial registration is still valid for continued registration.
The Radiation Control license is valid indefinitely. However, written confirmation must be provided annually (every September) that the CE Certificate on which the license is based is still valid.
LICENSE TRANSFER: License transfer is not possible.
AUTHORIZED REPRESENTATIVE: Foreign manufacturer must appoint a company residing within the Republic of South Africa to act as their Authorized Representative (AR).
ADDITIONAL INFORMATION: As Radiation Control Department has now become a part of SAHPRA, there will be only 1 official fee and 1 submission required for both SAHPRA license and radiation control, although there will be 2 licenses issued.
Other Sub-Saharan African Countries: Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Central African Republic, Chad, Comoros, Congo, DR Congo, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Ghana, Guinea, Guinea – Bissau, Ivory Coast, Kenya, Lesotho, Liberia, Madagascar, Mali, Mozambique, Namibia, Niger, Nigeria, Rwanda, Senegal, Sierra Leone, Somalia, South Sudan, Swaziland, Tanzania, Togo, Zanzibar