Regardless of its risk classification, all medical devices for importation and supply must be registered in Uganda. Foreign manufacturers entering the Ugandan market can leverage their existing approvals in recognized reference markets (Australia, Canada, European Union countries, Japan, and the United States) with expedited reviews and shortened registration timelines.
Three registration tracks are currently available.
- Track 1 for products registered and approved in IMDRF countries
- Track 2 for Products prequalified by WHO or registered in SRA countries
- Track 3 for products with no prior approval by any of our reference regulatory agencies considered SRA, IMDRF country or WHO prequalified.
Refer to our guideline for registration of medical devices for further guidance (link to guideline for registration)
Notify changes to registered medical devices
Inform NDA of any changes to a registered medical device currently through a Variation application.
In general, any person who imports or sells or locally produces a medical device for human or animal use in Uganda requires a license. An applicant may apply for one of three types of licenses for medical device outlets: manufacturer (manufacture, pack, label, import, export), Supply (import, export, store, & distribute)
Import permit allows the applicant to bring medical devices into Uganda
Wholesale license allows applicant to
- Supply medical devices by wholesale
- Supply medical devices to another party for resupply
Manufacturer’s license allows applicant to
- Make, fabricate produce or process medical devices
- Package and label medical devices before they are supplies
Applications for a license are submitted online through https://portal.nda.or.ug/