Medical Devices: Licensing + Startup

Theres a lot to unpack in this one. First start with the basics of understanding all categories and how medical devices are classified. From covid test kits, to glucometers there are a lot of Principles, and algorithms to consider and understand. Then, learn about the licensing categories (manufacturing, distribution, wholesale, and the new export only one) as well as the processes for application in each case. Lastly, review local and international guidelines and important industry communication set out by the WHO, EMA, and the national regulatory authority (SAHPRA).