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UGANDA MEDICAL DEVICE REGISTRATION

UGANDA MEDICAL DEVICE REGISTRATION

Regulatory Authority: National Drug Authority

The National Drug Authority (NDA) oversees the importation, production, exportation, and distribution of medical devices within Uganda, aiming to protect public health. Medical devices fall under the regulatory purview of Ministerial Decree ADM.140/323/01 issued on July 20, 2020, and Statutory Instrument No. 77 governing the Regulation of Surgical Instruments and Appliances in 2019.

NDA mandates that companies obtain licenses prior to engaging in domestic manufacturing, importing, or supplying of medical devices.

Furthermore, all medical devices must undergo registration with NDA before being distributed within Uganda.

Link to Regulatory Authority: https://www.nda.or.ug/medical-devices/#1603100276938-1176a4bd-aea2

Local Regulation/Guidelines: Guidelines on Registration of Surgical Instruments and Appliances

Link for Regulation/Guidelines: https://www.nda.or.ug/wp-content/uploads/2022/02/Guidelines-on-Registration-of-Surgical-Instruments_R0_2020_Final.pdf

Classification: Class A, B, C and D

Classification Guidelines

Classification

Level of risk

Examples

Class A

Low

Surgical retractors / tongue depressors

Class B

Low – moderate

Hypodermic Needles / suction equipment

Class C

Moderate – high

Lung ventilator / bone fixation plate

Class D

High risk Where risk relates to the patient or to public health

Heart valves / implantable defibrillator

Premarket Requirements:

  • All medical devices for importation and supply must be registered in Uganda, regardless of risk classification. Foreign manufacturers must appoint Authorized Representative and they can use existing approvals in recognized markets like Australia, Canada, EU countries, Japan, and the US for expedited reviews and shorter registration timelines.
  • The company registration documents should be submitted at the same time with the registration files of its first product/s.
  • Application for variation of a registered surgical instrument and appliance shall be made using Variation form.

Registration Requirements:

  • All applicants shall be required to submit a dully filled application form – Form 7
  • Bank deposit slip (prove of payment)
  • Details of the Surgical Instrument/appliance/appliance.
  • Certificate of conformity
  • All certificates / documents issued by an assessment body as evidence of regular approval or clearance.
  • Manufacturing process (Master formula, manufacturing steps, sterilization method used, and manufacturing facilities with steps performed at each facility).
    • A flowchart for the manufacturing process along with the relevant manufacturing sites should be provided.
  • Letter of Authorization
  • Performance & Safety clinical studies (where applicable, upon request)
  • Status of Surgical instrument / appliance distribution.

The technical requirements for registration should be submitted within the application for registration, corresponding to the surgical instrument or appliance class. The requirements should be attached to the application file, along with a covering letter.

Registration Dossier:

A separate and complete dossier in electronic form for each surgical instrument and or appliance(s), group or family shall be submitted.

Class A:

  • Application form (Form 7)
  • LoA
  • IFU, Catalogues and brochures
  • Labels
  • Sterilization methods (if applicable)
  • ISO 13485

Class B, C and D:

Registration Track:

  • There are three registration tracks that 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.
  • The specific documents required will vary depending on the registration track.
  • The registration will be done via NDAMIS portal.
  • Inform NDA of any changes to a registered medical device currently through a Variation application.

Track 1 – Applications for appliances licensed in one of the IMDRF Member countries should contain:

  • A covering letter containing the applicant’s attestation that all information in the application is true and correct.
  • Product details
  • Manufacturer details
  • Notarized copy of a license in the IMDRF founding member country

IMDRF Countries

AUS

Canada

EU

Japan

USA

Marketing permit

CE Mark/ GMPALS License

Appliance License

CE Mark

Appliance License

510K Appliance Letter

Certificate of Analysis

ISO 13485 or ISO 13488

ISO 13485 or ISO 13488

ISO 13485 or ISO 13488

GMP

QS (21 CFR part 820)

Certification Body

Govt or Third party accredited by the EU

Third party accredited by the EU

Third party accredited by the EU

Govt

Govt

  • Evidence of repeat sales in country of manufacture.
  • Appropriate number product samples, where practicable
  • A filled application submission checklist

Track 2-  Applications for appliances NOT licensed in one of the IMDRF Member Countries

  • A covering letter containing the applicant’s attestation that all information in the application is true and correct.
  • Product details
  • Manufacturer details
  • Certificate of Analysis Eg ISO 13485
  • Notarized copy of a license eg CE mark
  • Evidence of repeat sales in country of manufacture.
  • Appropriate number product samples, where practicable
  • A filled application submission checklist

Track 3 – Applications for appliances that do NOT have certification

  • A covering letter containing the applicant’s attestation that all information in the application is true and correct.
  • DoC
  • Summary information on pre-clinical design verification and validation
  • Product details
  • Manufacturer details
  • Evidence of repeat sales in country of manufacture.
  • Appropriate number product samples, where practicable
  • A filled application submission checklist

Registration Validity:

  • The registration or listing of a surgical Instrument and appliance shall remain valid unless suspended or revoked or for that matter terminated.
  • The validity of registration shall be subject to:-
  1. Submission of annual post-marketing surveillance reports for those products defined by the NDA to be of high risk or that require special attention.
  2. Submission of adverse effects reports associated with the use of surgical instruments and appliances. (Applicable for products classified as class D)
  • The holder of a certificate of registration shall pay an annual retention fee prescribed by the Authority, for maintaining the surgical instrument on the Register

Adverse Event Reporting:

  • All companies dealing in medical devices including importers, manufacturers, suppliers and registrants are required to report adverse events of their products.
  • The principle is to report adverse events (AE) that meet the three basic reporting criteria, indicating that there should be a pre-disposition to report in case of doubt:
    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.

Advertising and Promoting:

It is the responsibility of the advertiser to ensure compliance with the regulation and guidelines for advertisements and promotions of medical devices.

Please submit your advertisement or promotional material for vetting at [email protected].

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