Medical Devices Registration In South Africa

What is Medical Devices?

A medical device is any device intended to be used for medical purposes. 

Medical Devices Registration In South Africa

Registration Process

  • 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 applies to the Medicines Control Council (MCC)
  • A medical device will be included in the Medical Device register 

Documents Required

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

Applicable QMS

ISO 13485

Registration Timeline

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

License Validity

5 years

Special Notes

  • 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 comply 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.