Webinar - Logo Lockup

New-Era Innovations in Medical Devices and their Regulation under South African Law



September 30th, 10:30 AM CAT

New medical devices arrive at record speed ...

... But what is the response of South Africa's legal and regulatory bodies?


  • Not all medical devices have been created equal.  How are they classified by their intended use and design?

  • What is the impact of acts like POPI and Electronic Communications Act on new medical devices, such as apps and wearables?

  • Covid-19 saw the rapid and widespread introduction of ventilators.  How does the government seek to regulate these?

  • What are the latest draft amendments to the Regulations relating to medical devices, 2021 (GN - 435/GG - 44593) and how will they streamline regulations across supply, registration, licencing, management and investigations?
“Innovation, the pandemic, and regulations are shifting the Life Sciences industry in dynamic and interesting ways, staying in the know on how legislative changes impact your business is par for the course now more than ever before in this new normal”.
Tania Siciliano - Fasken

Fasken and Afriwise have teamed up to bring you this webinar: one of Africa’s leading law firms and Africa’s dedicated online platform for business and regulatory information.


Our panel of experts will explore the following:

  • The Current Regulatory Framework for Medical Devices in South Africa
  • The Regulation of Personal Protective Equipment as medical devices
  • Mechanical Ventilators
  • Digithealth in South Africa (including the use of health 'apps')
  • Upcoming Developments in the Regulation of Medical Devices

A clear and bold header


Fasken South Africa
Fasken, South Africa
Founder and CEO
Communications Specialist
Covid-19 has supercharged the introduction of medical devices. South Africa is the perfect place to capitalise on this rapid growth.
Steven De Backer - Afriwise


Join this webinar -- September 30th, 10h30 AM CAT
Join us and many other major multinationals to find out about the operating framework for Medical Devices and Life Sciences in South Africa.