Africa
This article highlights what CE marking is, how to obtain it, and the steps to follow to comply with EU regulations. Table of Contents Medical devices manufacturers willing to market products in the European Union (EU), must comply with the regulations established...
Africa
The new article highlights the aspects related to the classification rules to be applied with respect to in vitro diagnostic medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA) has published a guidance document dedicated...
Africa
The new article describes in detail the approach to be applied with respect to in vitro diagnostic medical devices, provides an overview of the classification principles, and highlights the key points to be considered in this respect. Table of Contents The South...
Africa
The new article highlights the aspects related to the classification rules to be applied with respect to invasive medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s agency responsible for ensuring the safety...
Africa
The new article highlights the aspects related to be taken into consideration with respect to the classification of active medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s regulatory agency in the sphere...
Africa
The new article addresses the aspects related to the existing classification rules for non-invasive medical devices and the way they should be applied based on the device, its intended use, and other factors. Table of Contents The South African Health Products...
