Uganda - Registration of Medical Device or In-Vitro Devices (IVDs)

Advertisement

Procedure

How to apply :

1. Eligible applicant should visit the National Drugs Authority for more information and application form
2. Accurately fill the application form and attach the required document and submit, the application in type written or computer printed in ENGLISH , hard copy and soft copy form and address it to The Executive Secretary / Registrar, National Drug Authority office.
3. Your application will be verified and processed by a committee appointed by National Drug Authority (NDA)
4. If all the information is in order, you will be issued with the licences

Advertisement

Required Documents

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

Office Locations & Contacts

National Drug Authority - Head Office,
Plot 19 Lumumba Avenue (opposite TWED plaza)
Kampala, Uganda
P. O Box 23096,
Kampala, Uganda
Tel: +256 [0]417 788 100
Directorate of Product Safety : +256 [0]417 788 124
Directorate of Inspectorate Services : +256 [0]417 788 129
Email : [email protected]
Website :Link

Eligibility

• The license holder
• The manufacturer
• An authorized local agent of the license holder or manufacturer, also known as Local Technical Representative (LTR), who may be a body corporate licensed to deal in medicines and/or medical devices, a diagnostic laboratory, hospital, health centre or clinic.

Fees

drug fees regulation
NOTE:
Payment of fees may be made by Bank Transfer to:
National Drug Authority, Stanbic Bank Uganda Limited, Kampala,
Account no: 0240060034201 OR by bank draft in favour of National Drug Authority.

Validity

The licence is valid for 5 years and renewable afterwards

Documents to Use

Please attach documents that can be used by people. e.g. links

Sample Documents

Please attach sample completed documents that would help other people.

Processing Time

Please explain processing time taken in obtaining the document/certificate.

Related Videos

Videos explaining the procedure or to fill the applications. 
Attach videos using the following tag <&video type='website'>video ID|width|height<&/video&> from external websites. 	
Please remove the '&' inside the tags during implementation.
Website = allocine, blip, dailymotion, facebook, gametrailers, googlevideo, html5, metacafe, myspace, revver, 
sevenload, viddler, vimeo, youku, youtube
width = 560, height = 340, Video ID = Can be obtained from the URL of webpage where the video is displayed.
e.g In the following url 'http://www.youtube.com/watch?v=Y0US7oR_t3M' Video ID is 'Y0US7oR_t3M'.

Instructions

Please provide other instructions related to the certificate/documents.
e.g. The state office holds birth records since january 1908.

Required Information

• Proprietary/brand name
• Brief description of the device
• Category of the device
• Intended use and method of use
• Medical specialty in which the device is used
• Contraindications, warnings, precautions, potential adverse events
• List of accessories and other devices or equipment to be used in combination with the device.
• Variations in shape, style or size of the device, if applicable
• Labelling details
• Packaging description including pack sizes
• Recommended storage conditions
  
  

Manufacturer details shall comprise of the following information:

• The name, physical address, telephone number, fax number and e-mail
• Where different activities of manufacture of a given product are carried out at different manufacturing sites, the above particulars shall be provided for each site and the activity carried out at the particular site .
• A copy of a valid manufacturing licence for each site.
• The name, physical address, telephone number, faxes number, and e-mail of the manufacturer’s LTR

Need for the Document

The registration of medical device by the National Drug Authority (NDA) ensures that all medical devices or in vitro devices that are distributed, imported or exported in or out of Uganda are of benefits of the consumer’s interest.

Information which might help

Enter other informations which might help.

Other uses of the Document/Certificate

Please explain what are other uses of obtaining this document/certificate.
e.g. Birth Certificate can be used as proof of identity.

External Links

Guide lines

Others

More information which might help people.