Medical Device Registration In Uganda
A medical device can be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination for a medical purpose.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved, Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers, and closed loop artificial pancreas systems. Additionally, medical devices include in vitro diagnostic (IVD) products, such as reagents, test kits, and blood glucose meters.
Procedure For Medical Device Registration In Uganda
Eligible applicant should visit the National Drugs Authority for more information and application form
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.
Your application will be verified and processed by a committee appointed by National Drug Authority (NDA)
If all the information is in order, you will be issued with the licences
Requirements For Medical Device Registration In Uganda
The basic regulatory requirements that manufacturers of medical devices distributed in Uganda must comply with are,
Establishment registration
Medical Device Listing
Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA)
Investigational Device Exemption (IDE) for clinical studies
Registration Process For Medical Device Registration In Uganda
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
Required Documents For Medical Device Registration In Uganda
Filling out the application form of renewing the registration of medical equipment and reagents.
The original registration certificate of the product issued previously by the Drug Control Department.
A valid manufacturing certificate of the factory issued by MOHAP.
License Validity For Medical Device Registration In Uganda
The licence is valid for 5 years and renewable afterwards
Eligibility For Medical Device Registration In Uganda
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.
Cost For Medical Device Registration In Uganda
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.
Required Information For Medical Device Registration In Uganda
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 For Medical Device Registration In Uganda
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.
Office Locations & Contacts For Medical Device Registration In Uganda
The Executive Secretary / Registrar, National Drug Authority:
Plot 19 Lumumba Avenue (opposite TWED plaza)
P.O. Box 23096, Kampala, UGANDA,
Phone: (+256) [0]417 788 100 (Reception) +256[0]417 788124(Directorate of product safety)
+256 [0]417 788 129 (Directorate of inspectorate services)
E-mail: ndaug@nda.or.ug
Website: National Drug Authority