Guideline for Medical Devices Bundling for MAA- Ethiopian Food and Drug Authority (EFDA)

This guideline is intended to provide general criteria for bundling medical devices within one medical device marketing authorization application.

A medical device bundling criteria is needed to guide applicants during application submission for medical devices within one medical device marketing authorization application. In order to reduce the application processing time and to facilitate timely access of the products in the market, the authority permits bundling of the medical devices within a single premarket submission according to the criteria specified in this guideline.

The guidance is effective from April 2021.