Medical devices are classified into one of four classes: Class A( lowest class), Class B, Class C and Class D (highest class ). Classification is risk based and depends on the intended use of the device and also upon indications for use. Where a device has more than one specified purpose, the correct result will…
NDA considers a product to be a medical device, and subject to NDA regulation, if it meets the definition of a medical device below; A medical device mean any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used,…
About Medical DevicesRegistration and licensing requirementsAdvertisement and promotionAdverse events reporting of medical devicesAbout Medical DevicesScope of Regulation NDA regulates the import, manufacture, export and supply of medical devices in Uganda to safeguard public health. Medical devices are regulated under a ministerial decree ADM.140/323/01 of 20th July 2020 and statutory Instrument no 77 of the Surgical…
Guidelines on good manufacturing practice for surgical instruments and appliances Guidelines on Registration of Surgical Instruments and appliances Guidelines on quality requirements for medical face masks
The National Drug Authority (NDA) held a Research Roundtable Discussion on Thursday, 26th February 2026, titled “Protecting innovation in traditional and complementary medicines: The role of patent databases in regulatory practice”. The presentation was delivered by Lumu Bob Rogers, a Senior Registration Officer from the Uganda Registration Services Bureau (URSB). This training served as a…
Product SafetyInspectorate & EnforcementProduct Assessment & RegistrationProduct Safety Unauthorized sale of public family planning commodities in the private sector Regulation of promotion and advertisement of drug related information Fast-Track assessment of variations (Amendments) and CTD dossier applications Unauthorized Chinese Pill Tablets on the Market WHO Global alert on substandard (contaminated) pediatric cough syrups identified in…
