Medical Device Regulatory Requirements in Uganda

Regulatory Authority National Drug Authority (NDA)
Regulatory Authority Website Link Click Here
Device Classification A,B,C,D
Medical Device Regulations Medical Device Guidelines | Click Here
IVD Classification A,B,C,D
Device Classification Guidelines

If you would like a formal medical device classification from the NDA, consider submitting a formal request through the directorate of product assessment and registration registration@nda.or.ug

| Click Here
Registration Process Medical Device Registration and Licensing Requirements | Click Here
Registration Timeline 3 months
Conformity Assessment Route

Conduct of Clinical Trials( Amendment) Regulations 2024

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Requirement of Authorized Representative YES
Language Requirement Labels must be in English Language
Clinical Trials Information

Guidelines for the Conduct of Clinical Trials in Uganda

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Reportable Incidents

Any adverse event (AE), which meets the three basic reporting criteria listed below, is considered as a reportable adverse event:

  1. An adverse event (or potential AE) has occurred.
  2. The medical device is associated with the AE.
  3. The adverse event leads to one of the following outcomes:
  • It becomes a serious threat to public health.
  • The death of a patient, user or other person.
  • Serious deterioration in state of health of patient, user or other person.
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Adverse Event Reporting Form Download
Recalls

Guidelines for the Recall or Withdrawal of a Medical Product 

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Advertising and Promotions

It is the responsibility of the advertiser to ensure compliance with the regulation and guidelines for advertisements and promotions of medical devices.

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Additional Information

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.
Disclaimer: This website sources information from regulatory authorities and aims for accuracy, but regulations may change without notice. Users are advised to verify details with relevant authorities before making compliance decisions. We are not responsible for errors, omissions, or outdated content.

The above information is last updated on 03/May/2025

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