ETHIOBIOMEDICAL provides templates and other important resources that applicants can simply download and use for themselves to submit and process their applications with Ethiopian Food and Drug Authority (EFDA). We always keep close attentions with potential changes that may be applied by the EFDA and provide appropriate versions of these resources.
Medical Devices and In vitro diagnostic devices Guidelines
Guidelines for the Classification of Non-IVD medical devices
Guidelines for Registration Requirements of Non-IVD medical devices
Guidelines for the Classification of IVD medical devices
Guidelines for Registration Requirements of In Vitro diagnostic medical devices
General Guidelines for Marketing Authorization of Medical Devices
Guidelines for Software as Medical Devices (SaMD) and AI-enabled devices
Guidelines for Marketing Authorization of Low-risk medical devices
Guidelines for Grouping/Bundling of Medical devices and IVDs for Registration Application Submission