An overview of the regulatory requirements for medical devices and IVDs in Uganda
£50.00
Expand into Uganda: learn the regulatory requirements for medical devices and IVDs to navigate this emerging market with confidence
English
Dennis Mwesigwa, Brenda Kitimbo, Michael Mutyaba and Rachel J Mujawimana provide a comprehensive overview of the regulatory framework governing surgical instruments and appliances in Uganda, as established and administered by the National Drug Authority (NDA). Since its inception in 1993, the NDA has expanded its mandate beyond pharmaceuticals to include medical devices, with key regulatory legislation introduced in 2014 and 2019. The article outlines the classification system based on device risk, the detailed product registration process, including documentation, technical assessments, and Quality Management System requirements, and the registration tracks available. It further explores requirements for labelling, language, Good Manufacturing Practice compliance, clinical investigations, and post-market surveillance.
Specification: 12 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the August 2025 issue of the Journal of Medical Device Regulation.
