What is Medical Devices?
A medical device is any device intended to be used for medical purposes.
Medical Devices Registration In South Africa
- 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
- 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
- 6-8 weeks
- 10-15 working days (officially published timeline for expedited regulatory pathway during the COVID-19 pandemic)
- Radiation Control License – 30 days
- 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.