Medical Device Registration in

South Africa

English, Zulu, Swazi, Afrikaans, Sepedi, Sesotho, Setswana, Xitsonga, Xhosa, Tshivenda, Ndebele

Class A, B, C and D

Appoint an authorized representative (AR) in South Africa
Demonstrate the device meets Essential Principles
Demonstrate conformity by applying to a Conformity Assessment Body (CAB) or International Notified Body for the CA certificate
If the application is successful and the CA certificate is granted the RA will now prepare DoC
Prepare necessary documentation including Conformity Assessment Body (CAB) and DoC
AR submits an application to the Medicines Control Council (MCC)
A medical device will be included in the Medical Device register

Completed application form
Labels, IFUs, Package Inserts or Promotional materials
Letter of appointment as an authorised representative of the original manufacturer
Copy of the EC Certificate(s) issued by a recognised Notified Body
Copy of the EC Declaration of Conformity issued by the original manufacturer
Application Form
Technical Documentation

ISO 13485

6-8 weeks
10-15 working days (official published timeline for expedited regulatory pathway during COVID-19 pandemic)
Radiation Control License – 30 days

Yes

5 years

All documents should be submitted in English
Local testing is not required. However, additional licenses 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 in compliance with the conformity assessment requirements of the MDACS.
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.