Emergency Line: (002) 01061245741
Mon - Fri: 8.00am - 7.00pm
  • info@omcmedical.co.uk

Get In Touch:

Get In Touch:

  • info@omcmedical.co.uk
Youtube Linkedin Facebook
Call Us Now:
+44 2080667260 sales@omcmedical.com

Uganda

Home
Uganda

Medical Device Registration in Uganda

Ministry of Health

Ministry of Health of Uganda

Regulatory Authority

National Drug Authority (NDA)

Medical Device Regulation

  1. Ministerial decree ADM.140/323/01 of 20th July 2020

Official Language

English, Swahili

Classification

Class A, B, C, D

Registration Process

  • Determine the medical device classification
  • Appoint your Authorised Representative in Uganda
  • Registration can be via:

Track 1 – for products approved in IMDRF countries

Track 2 – for products prequalified by WHO

Track 3 – for products with no prior approval

  • The registration will be done via NDAMIS portal
  • Once approved, the device can be marketed in Uganda

Documents Required

  • Accurately detail application letter (Hard and soft copy)
  • Bank deposit slip (prove of payment)
  • Sample of the product (if applicable)
  • Documentation/Dossier
  • Prior market history and approvals

Post-market Requirements

Adverse Event Reporting

Authorized Representative

Yes

License Validity

5 years

Want to know more about this registration process?

Schedule a Meeting