Medical Device Registration in

South Africa

Ministry of Health

National Department of Health

Regulatory Authority

South African Health Products Regulatory Authority (SAHPRA)

Medical Device Regulation

Medicines and Related Substances Act, 1965

Regulatory Guidance for Medical Devices

Official Language

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

Classification

Class A, B, C and D

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 submits an application 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 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

Applicable QMS

ISO 13485

Registration Timeline

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

Authorized Representative

Yes

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 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.

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