MEDICAL DEVICE REGISTRATION AND APPROVAL IN Uganda

MEDICAL DEVICE REGISTRATION AND APPROVAL IN Uganda

General country-specific regulatory information is provided on this page for medical device registration and approval in Uganda
Last update: June 2024

Medical Device Regulations and Classification in Uganda

REGULATORY AUTHORITY:

The National Drug Authority (NDA).

REGULATORY STATUS:

In Uganda, only Surgical instruments and appliances are regulated and need to be registered. All the information below applies to these devices.

CLASSIFICATION SYSTEM

Surgical instruments and appliances are classified according to risk into Classes A-D, with A being the lowest risk and D being the highest.

TIMEFRAME

Once a query or request has been raised, processing shall halt until the response to the query has been received. If no response to the query or request is received within six months from the written query notification date, the application could be subject to cancellation or rejection.

SPECIAL REQUIREMENTS:

To verify compliance, a pre-registration GMP inspection or quality
system audit may be conducted as part of the evaluation of the surgical instrument/appliance.

LOCAL FEES (New Application):

Registration of imported surgical instruments and appliances: US$ 1,500

LOCAL FEES (Change Notification):

  1. Major amendment of an application for registration of imported surgical instruments and
    appliances; US$ 500
  2. Minor amendment of an application for registration of imported surgical instruments and
    appliances: US$ 200

LICENSE VALIDITY:

The registration or listing of a surgical instrument and appliance shall remain valid unless
suspended, revoked, or terminated.
The holder of a certificate of registration shall pay an annual retention fee prescribed by the
Authority to maintain the surgical instrument on the Register.

LICENSE TRANSFER:

License transfer is possible; the registration and timeline for this process will follow the license
amendment procedure for major changes.

AUTHORIZED REPRESENTATIVE:

Any manufacturer based outside Uganda must designate a local authorized representative who
is responsible for the registration process.

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.
Three registration tracks are currently available:

1. Track 1 for products registered and approved in IMDRF countries
2. Track 2 for Products prequalified by WHO or registered in SRA countries
3. Track 3 for products with no prior approval by any of our reference regulatory agencies
considered SRA, IMDRF country or WHO prequalified

Other Sub-Saharan African Countries: AngolaBeninBotswanaBurkina FasoBurundiCentral African RepublicChadComorosCongoDR CongoEquatorial GuineaEritreaEthiopiaGabonGambiaGhanaGuineaGuinea – BissauIvory CoastKenyaLesothoLiberiaMadagascarMaliMozambiqueNamibiaNigerNigeriaRwandaSenegalSierra LeoneSomaliaSouth AfricaSouth SudanSwazilandTanzaniaTogoZanzibar

 

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