Abstract

REGULATORY FRAMEWORK FOR MEDICAL DEVICES REGULATION IN ETHIOPIA: A REVIEW

*Ayana Beressa (B pharm, M.Sc. follower)

Abstract

Medical devices are used for the diagnosis, monitoring and treatment of virtually every disease or condition, and include familiar objects such as simple bandages to high-end MRI scanners. The demand for regulation medical devices is raised as its market is growing fast across different countries around the world. The present review discussed the current regulatory framework for medical devices in Ethiopia and it similarity with USA and EU. Although the approach for regulation of medical device is differ between USA and EU, the requirements for registration to ensure safety and efficacy of device before markets are almost similar in it composition. Ethiopia adopted an EU and GHTF based classification system for registration of medical device in order to ensure its safety and efficacy before marketing.

Keywords: Medical device, instrument, regulation, registration, harmonization.