Scope 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 Instruments and appliances Regulation 2019.

NDA requires companies to acquire licenses before manufacturing domestically, importing or supplying medical devices. All medical devices will require registration with us before they can be supplied in Uganda.

How to report

Report using our website by clicking on the link

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=UG

Or

Use the NDA med safety mobile phone app available on Google play

Toll free number 0800101999

Is it a Medical Device?

NDA considers a product to be a medical device, and subject to NDA regulation, if it meets the definition of a medical device below;

Guidelines

Classification of medical devices

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

Registration

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.

Licensing

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/

Advertisement and promotion

It is the responsibility of the advertiser to ensure compliance with the regulation and guidelines for advertisements and promotions of medical devices.(link to guideline for advertisement)

Please submit your advertisement or promotional material for vetting at druginfo@nda.org

What is an advertisement?

“Advertisement” refers to the publication, dissemination or conveyance of any information for the purpose of promotion, and the sale or use of the medical device by any means or in any form, including the following:

  • Publication in a newspaper, magazine, journal or other periodical
  • Display of posters or notices
  • Circulars, brochures, pamphlets, books
  • Letters address to individuals or organisational bodies
  • Photographs or films
  • Sound broadcasting, television, the internet and other media sources
  • Public demonstration of the use of the health product
  • Offer of trials of the health product to members of the public
  • Door to door sales
  • Exhibitions
  • Competitions
  • Any other activity intended to introduce, publicize or raise the profile or public awareness or visibility of any medical device for the purpose of promoting the sale or use of it

Advertisement prohibitions

Advertisements on registered “professional use only” medical devices are not allowed, unless the advertisement is distributed only to, or contained in, a publication intended to be circulated to qualified practitioners.

Advertising to the general public that claim, indicate or suggest that the medical device will prevent, alleviate or cure any of the following diseases or conditions is not allowed:

 

Amenorrhea Arteriosclerosis Bladder stones
Blindness Brights Disease Cancer
Cataract Deafness Diabetes
Diptheria Dropsy Epilepsy or fits
Erysipelas Gallstones Glaucoma
Goitre Heart disease Hernai
Kidney diseases Leprosy Locomotorataxy
Lupus Menstrual disorders Paralysis
Pleurisy Pneumonia Poliomyeletis
Scalet fever Schistomaisis Septicemia
Small pox Tetanus Trachoma
Tuberculosis

 

Guidelines on advertisements can be accessed here (link to guidelines for advertisements)

Adverse events reporting of medical devices

All companies dealing in medical devices including importers, manufacturers, suppliers and registrants are required to report adverse events of their products.

What to report

As a general principle, there should be a pre-disposition to report rather than not to report in case of doubt. 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.

There is no death or serious injury in the initial Adverse even but it might lead to death or serious injury of a patient, user or other person if the Adverse Event recurs

How to report

Report using our website by clicking on the link

https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=UG

Or

Use the NDA med safety mobile phone app available on Google play

Toll free number 0800101999