Adopting standard nomenclature for medical devices in Ethiopia

Abstract

After assessing all existing opportunities, the TF finally decided to adopt or recognize one of the existing nomenclatures based on predetermined criteria. Following a series of workshops that used nomenclature selection criteria recommended in the World Health Organization’s (WHO) Global Model Regulatory Framework for Medical devices including In vitro diagnostic medical devices (GMRF) document, the TF did the evaluation and forwarded the recommendation to higher officials of the Ministry and the Authority for endorsement. The selection criteria used were: Harmonization, Accessibility and ease of Use, Governance, Inclusion of Medical devices range, Timely updates, Used in source jurisdictions, Language, Transferability and interoperability. Using these criteria, the TF looked for the existing internationally recognized Medical device nomenclature systems and identified three nomenclatures to evaluate and select from. These are- Global Medical Device Nomenclature (GMDN), European Medical Device Nomenclature (EMDN) and Universal Medical Device Nomenclature System (UMDNS). The