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🇺🇬 Uganda IVD regulatory data

Explore the IVD requirements currently available for Uganda, organized by topic and linked to official sources.

10 facts5 dimensions6 official sourceslatest verification 2026-09-16

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in Uganda. Each question separates published rules from details still awaiting verification.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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'Surgical instrument' is the statutory term and expressly includes appliances, IVDs, reagents and software

scope.surgical-instruments-and-appliances
Fact-level verified

Uganda's device statute does not use the phrase 'medical device'. The regulated object is the 'surgical instrument', defined in reg. 24 of S.I. 2014 No. 29 as any instrument, apparatus, implement, machine, implant, in vitro reagent or calibrator, software, material or other similar or related article, and expressly including an appliance, intended by the manufacturer to be used alone or in combination, for human beings or animals for one or more of six listed purposes: diagnosis/prevention/monitoring/treatment/alleviation of disease; diagnosis/monitoring/treatment/alleviation of or compensation for an injury; investigation, replacement, modification or support of the anatomy or of a physiological process; supporting or sustaining life; disinfection of a surgical instrument; or providing information for medical purposes by in-vitro examination of specimens — and which does not achieve its primary intended action by pharmacological, immunological or metabolic means. 'In vitro diagnostic device' and 'test kit' are defined separately in the same regulation. DAR/GDL/028 s. 1.3 confines the guideline to registration of surgical instruments and appliances in Uganda only, and excludes instruments and appliances used for a patent application or a donation/gift.

Conditions
  • An 'appliance' is a subset of 'surgical instrument' in the Ugandan statute; the two words are used together throughout because the regulations and guidelines say 'surgical instruments and appliances'.
  • Both domains apply: reg. 24 defines 'in vitro diagnostic device' as a surgical instrument intended to be used in vitro for the examination of specimens taken from the body of a human being or of an animal, and reg. 1.3 of INS/GDL/047 states that its requirements apply to the manufacture of surgical instruments and appliances including in vitro diagnostics.
  • NDA's public-facing definition on its 'Is it a Medical Device?' page adds 'control of conception' to the list of intended purposes and names gauze roll, absorbent cotton, ventilators, incubators, syringes, BP machines, condoms, gloves, catheters and diagnostic kits as examples.

Effective from 2014-03-28

DAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and AppliancesIs it a Medical Device? — National Drug Authority

Excerpt is the reg. 24 definition of 'surgical instrument' verbatim, joined by [...] to the s. 1.3 scope sentence from DAR/GDL/028. Text-layer extraction renders the statutory quotation marks as typographic quotes; they are normalised to plain quotes here without altering wording. The 'control of conception' addition on NDA's own page is recorded in conditions rather than in the value because it is a webpage gloss on the statutory list, not the statutory list itself.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

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Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Uganda approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Uganda (5 records)

UgandaWHO · IMDRF member authorities · ISO

Prior approval / evidence record

WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA

Authority

WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA

Accepted

Yes

Benefit

Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.

National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

UgandaNMPA

Prior approval / evidence record

China NMPA registration certificate

Authority

China NMPA registration certificate

Accepted

No

Benefit

China is not on NDA's recognised-country list, which is closed: DAR/GDL/028 §4.11 enumerates the United States, Canada, Japan and Europe, Table 2 names Australia, Canada, the European Union, Japan and the United States, and the medical-devices page names the same five. An NMPA registration therefore does not put a product into Track 1 and does not satisfy the §4.11 gate for classes B-D; a Chinese-manufactured device reaches Uganda through Track 2 or Track 3, and the country-of-origin marketing approval must still be legalised and filed in every case.

National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

UgandaAustralia TGA · Health Canada · EU conformity assessment · Japan MHLW / PMDA · US FDA · IMDRF member authorities

Prior approval / evidence record

Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States

Authority

Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States

Accepted

Yes

Benefit

Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.

National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

UgandaUS FDA · Health Canada · Japan MHLW / PMDA · EU conformity assessment

Prior approval / evidence record

Recognised-country certification or CE certification — an eligibility gate for classes B, C and D

Authority

Recognised-country certification or CE certification — an eligibility gate for classes B, C and D

Accepted

Yes

Benefit

DAR/GDL/028 §4.11 makes certification from a recognised country (United States, Canada, Japan, Europe) or CE certification mandatory for classes B, C and D: devices not certified by any recognised country will be examined and may be exempted from the requirement only if they are class A. The European certificate required scales with class — full quality assurance or EC Type Examination Certificate for classes B and C, and full quality assurance or EC Design Examination Certificate for class D, from a notified body approved by European health authorities. This is a gate, not a fast track: it conditions eligibility and shortens nothing by itself.

National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

UgandaSource authority not specified

Prior approval / evidence record

Reagents and articles of a foreign-licensed test kit are deemed registered in Uganda

reliance.test-kit-deemed-registration
Fact-level verified
Statement

Uganda deems registered, for the purposes of importation, sale or advertisement, all the reagents or articles of an in-vitro diagnostic test kit that is licensed or registered outside Uganda, where those reagents or articles are manufactured by the manufacturer of the test kit. This is a statutory deemed-registration rule in S.I. 2014 No. 29 reg. 28(2) and it is unilateral: the foreign licence or registration is not required to come from any named country or any reference list, and no Ugandan application is described for the deemed reagents and articles themselves. It sits alongside reg. 28(1), under which a surgical instrument or group that forms part of another registered instrument or group is likewise deemed registered.

Source Approval

Any licence or registration of the test kit issued outside Uganda, by any jurisdiction; no reference-country list is imposed

Edge Type

Unilateral Recognition

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

No

Target Decision Retained

No

Conditions
  • The deemed registration attaches to the reagents or articles of the test kit, and only where they are manufactured by the manufacturer of the test kit.
  • The deeming is expressed 'for the purposes of its importation, sale or advertisement'.
  • The foreign licence or registration is not restricted to any named country or reference list, unlike the Track 1 and s. 4.11 mechanisms.
  • Read with reg. 28(1), which deems registered any surgical instrument or group forming part of an already-registered instrument or group.

Effective from 2014-03-28

New key, not an upgrade: no existing Uganda fact records this mechanism. edgeType 'unilateral_recognition' is reused from the existing vocabulary (1 prior use) because Uganda acts unilaterally on a foreign registration without any reciprocity or named reference country — which also distinguishes it from the Track 1 and s. 4.11 mechanisms that are keyed on a closed IMDRF list. 'deemed registered' is the statute's own phrase. The fact is scoped to IVD because reg. 24 defines 'test kit' as an in vitro diagnostic device.

Review clocks

What review, validation, and applicant stop-clock rules apply?

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Processing halts on a query; no response within six months may lead to cancellation or rejection (DAR/GDL/028 §4.2)

clock.applicant-query-response-six-months
Fact-level verified

Once NDA raises a query or a request for additional data or samples, processing of a surgical instrument/appliance application halts until the response is received. If no response is received within six months of the written query notification date, the application may be cancelled or rejected.

Conditions
  • Applicant-side clock; the guideline states no authority-side assessment period for device applications.

Effective from 2020-08-14

Guideline review due date was 14 Aug 2023; Rev 0 is still the version published on nda.or.ug on 2026-09-16.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

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Registration guideline does not apply to surgical instruments/appliances imported as a donation or gift (DAR/GDL/028 §1.3)

special.donated-or-gift-appliances-outside-registration-guideline
Fact-level verified

The device registration guideline expressly excludes from its scope surgical instruments and appliances that are the subject of a patent application or a donation/gift; donated devices therefore fall outside the registration tracks and are handled under the donation rules of the import regulations.

Conditions
  • Scope exclusion only; the guideline does not itself describe the donation route.

Effective from 2020-08-14

Importation for donation requires prior notification and written NDA authorisation with conditions; donated products must come from an approved source with at least one year shelf life (S.I. 34 of 2014, regs 13-14)

special.donation-import-written-authorisation-and-conditions
Fact-level verified

Under Part III of the Importation and Exportation of Drugs Regulations 2014, importation for donation is allowed only where the recipient or donor informs NDA of the necessity directly related to the recipient's disease pattern, notifies NDA before shipment of the range, quantities, population served and recipient, and NDA authorises the importation in writing specifying the conditions; the donated product is verified on arrival, must come from a source approved by NDA and have at least one year of remaining shelf life at entry.

Conditions
  • The Regulations are drafted in terms of 'drug' (reg. 2 definition mirrors the Act); they do not name surgical instruments or appliances, although the device registration guideline excludes donated appliances from registration and NDA's Medical Devices page treats devices as regulated products.
  • Regulation 14(2) refers to conformity with authorised pharmacopoeias, a medicine-oriented criterion.

Effective from 2014-03-28

Regulations 15-20 add: original unopened packaging with English labelling, transport costs borne by donor/recipient, a certificate of donation, accountability returns by the recipient, prohibition of sale or transfer, and re-export of non-compliant donations. Read from the Government of Uganda trade-portal copy; the NDA copy is the same gazette scan.

Drugs outside the national formulary may be imported and sold on NDA authorisation to meet emergency or extraordinary circumstances (NDPA Act s.8(4))

special.emergency-import-authorisation-outside-national-formulary
Fact-level verified

Section 8(3) of the Act prohibits importing or selling any drug not on the national formulary, but section 8(4) allows a drug not on the formulary to be imported and sold after authorisation by the Drug Authority to meet emergency or extraordinary circumstances.

Conditions
  • 'Drug' is defined in section 1 as any substance or preparation used for internal or external application to the human or animal body in the treatment or prevention of disease or for improving physiological functions; surgical instruments and appliances are addressed separately under the regulation-making power in s.64(1)(g), so application of s.8(4) to devices is not explicit on the face of the Act.

Section 1 definition: '“drug” means any substance or preparation used or intended to be used for internal or external application to the human or animal body either in the treatment or prevention of disease or for improving physiological functions, or for agricultural or industrial purposes;'. Section 64(1)(g): 'regulating, restricting or prohibiting the importation, sale or advertising of surgical instruments and appliances;'.

Exemption from sample submission may be requested for large or very expensive appliances (DAR/GDL/028 §4.2)

special.sample-submission-exemption-large-or-expensive-appliances
Fact-level verified

Applicants may ask NDA for exemption from submitting product samples for large appliances or those that are extra expensive; NDA may then consider the product catalogue and/or a sample viewing instead.

Conditions
  • Discretionary; applies to the sample element of the dossier only.

Effective from 2020-08-14

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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'Recognized Standards' are national or international standards deemed to give presumption of conformity to essential principles (DAR/GDL/028 §2.0)

standards.recognized-standards-presumption-of-conformity
Fact-level verified

The registration guideline defines Recognized Standards as national or international standards deemed to offer the presumption of conformity to specific essential principles of safety and performance; the guideline does not publish a list of recognised standards.

Conditions
  • Definition only; no standards list is annexed to the guideline. The reference list cites EN ISO 13485:2016 and the IMDRF Essential Principles document.

Effective from 2020-08-14

Section 5.0 References lists, among others, 'EN ISO 13485:2016 Medical devices - Quality management systems' and 'Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices' (IMDRF/GRRP/N47).

Track 3 applications (no recognised QMS certification) must include a manufacturer's Declaration of Conformity to the IMDRF Essential Principles and pre-clinical verification/validation summaries (DAR/GDL/028 §4.12.3)

standards.track-3-declaration-of-conformity-to-imdrf-essential-principles
Fact-level verified

For appliances without certification to any of the quality-system standards in Table 3, the application must contain the manufacturer's Declaration of Conformity to the IMDRF Essential Principles of Safety and Performance (or the checklist in Appendix II), summary information on pre-clinical design verification and validation, product and manufacturer details, evidence of repeat sales in the country of manufacture, product samples where practicable and the submission checklist.

Conditions
  • Track 3 only; Track 1 and Track 2 rely instead on a notarised reference-country licence or a recognised QMS certificate plus certificate of analysis.

Effective from 2020-08-14

Appendix II is the 'Essential Principles Checklist in Registering of Surgical Instruments and Appliances' (pages 24-35), whose columns ask for the method of conformity and identity of specific documents per principle.

Imported consignments must carry a batch certificate of analysis and a certificate of conformity or test report, checked by NDA at the port of entry (S.I. 34 of 2014, reg. 9)

testing.batch-certificate-of-analysis-or-conformity-at-port-of-entry
Fact-level verified

Imported drugs must be accompanied by the certificate of analysis issued in the country of manufacture and the certificate of conformity or test report for the specific batch or lot; on arrival NDA inspects the consignment to confirm compliance with approved specifications and that each batch has a certificate of analysis.

Conditions
  • Regulation drafted for 'drugs'; the Service Delivery Timelines nevertheless list a 25-working-day clock for mandatory testing of medical devices after sampling, showing NDA applies port-of-entry testing to devices.

Effective from 2014-03-28

Regulation 6 requires a verification certificate (Form 25/26) per consignment before importation; Form 25 asks whether the drugs are registered and states that unregistered items must be registered prior to importation.

Related structured datasets

Classification systems · 0 records

No maintained record.

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Uganda registration →
Country

Uganda

Jurisdiction Id

uganda

Country Code

UG

Flag

🇺🇬

Regulator

National Drug Authority (NDA)

Regulator Abbrev

NDA

Region

africa

Tier

3

Risk Classification

4-class (A, B, C, D) — NDA's own risk axis from Class A (low risk) to Class D (high risk, where the risk relates to the patient or to public health), applied from the classification rules in DAR/GDL/028 Rev 0 (Appendix VII and Table 1); every device must be registered before importation or supply regardless of class

Classes
  • Id

    surgical-instruments-registration

    Class Name

    Surgical instruments and appliances — registration by the Authority

    Pathway

    Application to the National Drug Authority for registration of a surgical instrument before manufacture, importation or exportation, on Form 7 of Schedule 6 to S.I. 2014 No. 29 (reg. 27(1)-(2)), filed by the patent holder, a licensed person, the manufacturer, or an agent authorised by the manufacturer or patent holder (reg. 27(3)); registration is a precondition of sale or distribution (reg. 25(1))

    Official Timeline
    Min

    60

    Max

    60

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

    Url

    https://www.nda.or.ug/wp-content/uploads/2022/03/Drug-Registration-Regulation.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    6

    Unit

    months

    Notes
    • Reg. 38(1) of the National Drug Policy and Authority (Registration) Regulations, 2014 (S.I. 2014 No. 29), Part IV: 'The Authority shall determine an application for registration under these Regulations, within sixty days from the date of receipt of the application.' It is the only clock in the instrument that runs against the Authority, and reg. 38(2)-(4) name the three decisions it governs — approve and register, require further information, or refuse with reasons.
    • The device scope is established by reg. 2(c), which applies the Regulations to 'surgical instruments', and by Part III (regs. 24-35, Registration of Surgical Instruments), reg. 25(1) of which requires all surgical instruments to be registered by the Authority before sale or distribution. The unit is calendar days: the regulation says 'within sixty days', not working days or business days.
    • THE SIXTY DAYS IS NOT A WALL-CLOCK PROMISE, and the reasons are recorded rather than smoothed over. Reg. 37 lets the Authority require further information and samples in the course of examining an application without any time limit and contains no clock-stop rule; NDA's registration guideline then supplies the stop rule the statute lacks — 'Once a query or a request has been raised, the processing shall halt until after the response to the query has been received' — and adds that an application may be cancelled or rejected if no response is received 'within six months from the written query notification date'; and the licence applications that must be lodged alongside registration at NDA carry no period at all. The realistic range covers those unclocked steps around the statutory 60 days.
    • Registered surgical instruments are recorded in the register kept under reg. 26 in the format of Schedule 5; the certificate of registration is Form 8 under reg. 30(2) (Schedule 7), and a first registration certificate is valid for five years under reg. 40(1).
    • The instrument read in full is the gazetted text of S.I. 2014 No. 29 (https://www.nda.or.ug/wp-content/uploads/2022/03/Drug-Registration-Regulation.pdf — NDA's own 'NDPA Act & Regulations' page links it under the title 'Drug Registration Regulation', the only registration regulation the Authority publishes). NDA's medical-devices page cites a later device instrument, 'statutory Instrument no 77 of the Surgical Instruments and appliances Regulation 2019', which could not be retrieved on any transport and is not listed on the Authority's own legislation page, so whether it amends or replaces this clock is unresolved and is recorded as such in the entry's other rows.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    Yes

Prior Approvals
  • Authority

    Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States

    Accepted

    Yes

    Benefit

    Track 1: an abridged evaluation in which the foreign approval carries the technical assessment, with a much smaller submission (attestation, abbreviated product and manufacturer details, notarized copy of the licence, Certificate of Analysis to an accepted quality-system standard, evidence of repeat sales and product samples where practicable). It is an expedited review with shortened registration timelines, but NDA publishes no number for the shortening and the final decision remains NDA's.

  • Authority

    WHO Prequalification, or quality-system certification from a certification body accredited by a regulatory authority in an IMDRF founding-member country, or any other international organisation recognised by NDA

    Accepted

    Yes

    Benefit

    Track 2: accepted as a documentary substitution for an IMDRF-country licence under DAR/GDL/028 §4.12.2 — the foreign element that unlocks the route is the quality-system certification and its accreditation rather than a product approval, and no shortened period is published for it.

  • Authority

    Recognised-country certification or CE certification — an eligibility gate for classes B, C and D

    Accepted

    Yes

    Benefit

    DAR/GDL/028 §4.11 makes certification from a recognised country (United States, Canada, Japan, Europe) or CE certification mandatory for classes B, C and D: devices not certified by any recognised country will be examined and may be exempted from the requirement only if they are class A. The European certificate required scales with class — full quality assurance or EC Type Examination Certificate for classes B and C, and full quality assurance or EC Design Examination Certificate for class D, from a notified body approved by European health authorities. This is a gate, not a fast track: it conditions eligibility and shortens nothing by itself.

  • Authority

    China NMPA registration certificate

    Accepted

    No

    Benefit

    China is not on NDA's recognised-country list, which is closed: DAR/GDL/028 §4.11 enumerates the United States, Canada, Japan and Europe, Table 2 names Australia, Canada, the European Union, Japan and the United States, and the medical-devices page names the same five. An NMPA registration therefore does not put a product into Track 1 and does not satisfy the §4.11 gate for classes B-D; a Chinese-manufactured device reaches Uganda through Track 2 or Track 3, and the country-of-origin marketing approval must still be legalised and filed in every case.

Key Requirements
  • All surgical instruments and appliances must be registered by the Authority before they are sold or distributed (reg. 25(1) of S.I. 2014 No. 29), on Form 7 of Schedule 6 (reg. 27(2)); the application may be made by the patent holder, a licensed person, the manufacturer, or an agent authorised by the manufacturer or patent holder (reg. 27(3)), and the particulars the application must contain are listed in reg. 27(4)(a)-(l).
  • A declaration by the authorised local technical representative of the applicant must be submitted for all applications, undertaking that the submitted documents are an accurate reflection of truth, that the representative is fully responsible for the product and the post-market plan for complaint handling or recall, and that it will comply with NDA's post-market requirements; the local technical representative is also the party that must submit corrected or new artwork where NDA requires it, and a product will not get marketing approval until the Local Technical Representative in Uganda submits the artwork with a sample from the first consignment (DAR/GDL/028 §4.3.1).
  • For classes B, C and D, certification from a recognised country or CE certification is mandatory and only class A may be exempted from it (DAR/GDL/028 §4.11); the European certificate required scales with class, and the notified body must itself be approved by European health authorities.
  • A separate and complete dossier in electronic form is required for each surgical instrument, appliance, group or family, with two content sets: for class A, the filled application form, letter of authorization, IFU and promotion material, labelling information, sterilization information where applicable and proof of a quality management system such as ISO 13485; for classes B, C and D, the filled application form, letter of authorization, appliance details, a summary of technical documentation, labelling information, evidence of conformity to the Essential Principles checklist and the quality-system proof (DAR/GDL/028 §4.3.3.1).
  • Labelling must carry nine elements — the name of the instrument, the manufacturer's name and address, the instrument identifier, package contents where not readily apparent, the word 'Sterile' where applicable, the expiry date, the medical conditions, purposes and uses, the directions for safe and effective use and any special storage conditions — provided in English, permanently and prominently, in terms easily understood by the intended user (regs. 29(1)-(2) and 35).
  • Gazetted fees apply: under the National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67, in force 1 October 2025, revoking the 2022 Fees Regulations) first registration of an imported surgical instrument is US$1,500 and of a locally manufactured one US$200; annual retention is US$200 for an imported device and US$100 for a locally manufactured one; a major amendment of an imported-device application is US$500, a minor amendment US$200 and a notification of amendment US$50. Fees are non-refundable and payable on application, and NDA will not receive an application for which the fee is unpaid.
  • Renew before expiry: the renewal application must reach the Authority at least 90 days before the registration expires, in writing, with a consolidated report of the changes made during the registration's validity whether or not they were reported, a report of adverse reactions detected during the product's lifetime, five samples of the packaging in the form in which it is to be marketed and the prescribed fee (regs. 42(1)-(2)).
  • Keep the registration in force: an annual retention fee must be paid to remain on the Register and annual post-marketing surveillance reports must be submitted for products NDA treats as high risk or requiring special attention, with adverse-effect reports; a registration may be terminated by the registrant on 30 days' written notice with reasons, and NDA may suspend or revoke a registration, or amend its conditions, giving reasons in writing (S.I. 2014 No. 29 reg. 40 and DAR/GDL/028 §§4.5-4.7, 4.14).
  • Answer a query: processing halts once a query or request is raised and resumes on the response, and an application may be cancelled or rejected if no response is received within six months of the written query notification date (DAR/GDL/028 §4.3.1).
Local Rep Required

Yes

Local Rep Name

Authorised local technical representative in Uganda, which must declare responsibility for every application and is the party that submits corrected or new artwork; reg. 27(3) of S.I. 2014 No. 29 does not itself require the applicant to be resident in Uganda, so the operative local-actor requirement is the technical-representative declaration in DAR/GDL/028 §4.3.1.

Mdsap Accepted

No

Mdsap Benefit

Uganda has no MDSAP provision. S.I. 2014 No. 29, DAR/GDL/028 and NDA's device pages do not name MDSAP: the quality-system evidence the guideline asks for is 'an ISO 13485 certificate' or the equivalent, and Track 2's substitution turns on certification from a body accredited by an IMDRF founding-member regulatory authority, which is a broader test that does not reference the MDSAP programme. No MDSAP-related reliance row exists for this jurisdiction.

Registration Validity

Two answers are published and they disagree, so both are carried. S.I. 2014 No. 29 reg. 40(1) gives a first registration certificate five years and a renewal certificate one year from issue, with renewal to be filed at least 90 days before expiry (reg. 42(1)). NDA's registration guideline states the opposite term — that registration or listing of a surgical instrument or appliance 'remains valid unless it is suspended, revoked or terminated', subject to the annual retention fee and to annual post-marketing surveillance and adverse-effect reports for products NDA treats as high risk or requiring special attention (DAR/GDL/028 §§4.5-4.7, 4.14). Whether S.I. 77 of 2019 of the Surgical Instruments and Appliances Regulations changed either is unresolved: that instrument could not be retrieved on any transport and is not published on NDA's own legislation page.

Last Updated

2026-09-16

Verification Status

partially-verified

Official Sources
  • Title

    National Drug Authority — Drug Registration Regulations, 2014 (S.I. 2014 No. 29), regs. 38 and 42 made under the National Drug Policy and Authority Act, Cap. 206

    Url

    https://www.nda.or.ug/wp-content/uploads/2022/03/Drug-Registration-Regulation.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by NDA. Appoint a Authorised local technical representative in Uganda, which must declare responsibility for every application and is the party that submits corrected or new artwork; reg. 27(3) of S.I. 2014 No. 29 does not itself require the applicant to be resident in Uganda, so the operative local-actor requirement is the technical-representative declaration in DAR/GDL/028 §4.3.1..

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to NDA including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    NDA reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. NDA may issue questions.

    Duration

    60 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, NDA issues Uganda market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Uganda fees →
Jurisdiction Id

uganda

Country

Uganda

Country Code

UG

Authority

NDA

Low Risk Local
Min

200

Max

1500

Currency

USD

Per Product

No

High Risk Local
Min

200

Max

1500

Currency

USD

Per Product

No

Details
  • Id

    registration-imported-device

    Item

    Application for registration of imported surgical instruments and appliances

    Currency

    USD

    Amount Local

    1500

    Amount Local Formatted

    USD 1500

    Frequency

    Per application

    Notes

    Schedule Part 1 item 1(e). The fee for first registration of an imported device.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

  • Id

    registration-locally-manufactured-device

    Item

    Application for registration of locally manufactured surgical instruments and appliances

    Currency

    USD

    Amount Local

    200

    Amount Local Formatted

    USD 200

    Frequency

    Per application

    Notes

    Schedule Part 1 item 1(f). The same register entry as an imported device, at a lower fee.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

  • Id

    annual-retention-imported-device

    Item

    Retention of imported surgical instruments and appliances on the Register

    Currency

    USD

    Amount Local

    200

    Amount Local Formatted

    USD 200

    Frequency

    Per year

    Notes

    Schedule Part 1 item 2(e). Registration is not perpetual: the device stays on the Register only while retention is paid.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

  • Id

    annual-retention-locally-manufactured-device

    Item

    Retention of locally manufactured surgical instruments and appliances on the Register

    Currency

    USD

    Amount Local

    100

    Amount Local Formatted

    USD 100

    Frequency

    Per year

    Notes

    Schedule Part 1 item 2(f).

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

  • Id

    major-amendment-imported-device

    Item

    Major amendment of an application to register an imported surgical instrument or appliance

    Currency

    USD

    Amount Local

    500

    Amount Local Formatted

    USD 500

    Frequency

    Per amendment

    Notes

    Schedule Part 3. A notification of amendment is charged separately at a lower amount.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

  • Id

    minor-amendment-imported-device

    Item

    Minor amendment of an application to register an imported surgical instrument or appliance

    Currency

    USD

    Amount Local

    200

    Amount Local Formatted

    USD 200

    Frequency

    Per amendment

    Notes

    Schedule Part 3.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

  • Id

    notification-of-amendment

    Item

    Notification of amendment

    Currency

    USD

    Amount Local

    50

    Amount Local Formatted

    USD 50

    Frequency

    Per notification

    Notes

    Schedule Part 3. The cheapest post-registration change route.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

  • Id

    examination-of-surgical-instruments

    Item

    Examination of surgical instruments and appliances by the Authority in the course of performing its functions

    Currency

    USD

    Amount Local

    1000

    Amount Local Formatted

    USD 1000

    Frequency

    Per batch

    Notes

    Schedule Part 8 item 1(c). Where analysis is performed in a laboratory not owned by the Authority, the cost is the cost of testing plus 10%.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Source Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Source Effective Date

    2025-10-01

    Verified On

    2026-09-16

Notes
  • The 2025 Regulations came into force on 1 October 2025 and revoked the National Drug Policy and Authority (Fees) Regulations, 2022 (S.I. 5 of 2022). They were made on 9 September 2025 under section 61 of the National Drug Policy and Authority Act and published as S.I. 2025 No. 67 in Uganda Gazette No. 72, Volume CXVIII of 17 September 2025.
  • The tariff differentiates an imported from a locally manufactured device, not by risk class: no class-based fee head appears in Part 1, so both published bands carry the same spread of USD 200 to USD 1500 for first registration.
  • Amounts were read by OCR from the scanned gazette PDF; the fee figures are legible but the surrounding table layout in the OCR text is not reliable.
  • Fees are non-refundable whether or not the application succeeds and are payable when the application is made; NDA will not receive an application for which the prescribed fee is unpaid.
  • An amendment of an application before registration is 10% of the applicable fee, and fast tracking is charged at 300% of the applicable fee. Both are percentages of another fee rather than published amounts and are excluded from the details.
  • The fast-tracking head in Part 1 covers fast tracking of applications for registration of drugs only; no separate fast-track registration fee for surgical instruments and appliances appears in Part 1.
  • Uganda shilling heads in the same instrument, such as the wholesale licence for surgical instruments and appliances and the inspection fee of UGX 3,500,000 per facility, are excluded from this record, which publishes the US-dollar registration tariff only.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    National Drug Policy and Authority (Fees) Regulations, 2025 (S.I. 2025 No. 67), Schedule Part 1 items 1(e)-(g) and 2(e)-(f), Part 3 items 3(g)-(i) and Part 8 item 1(c)

    Url

    https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf

    Effective Date

    2025-10-01

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Uganda certifications →
Slug

uganda

Market

Uganda

Confidence

low

Schemes
  • Id

    uganda-ucc-equipment-type-approval

    Name

    UCC type approval of communications equipment

    Category

    Radio Spectrum

    Status

    Mandatory Pre Market

    Object

    Radio Equipment

    Note

    The Uganda Communications Commission's Type Approval Framework for Communications Equipment in Uganda, made under section 5(i) and (k) of the Uganda Communications Act 2013 and the Uganda Communications (Equipment Type Approval) Regulations 2019, states that 'Type Approval of Communication Equipment is a mandatory requirement before importation, use or sale in Uganda'. Type approval is defined as the process by which communications equipment that meets the Commission's minimum technical requirements is authorised to be sold, distributed, imported or used in Uganda, and it applies to manufacturers, importers, distributors, sellers and operators alike. Applications are filed through the Commission's online portal, the file is reviewed, the applicant is invoiced and the certificate issues after payment. The type approval page publishes the applicable fees in US dollars per annum, including USD 20 application processing, USD 100 for radio equipment, USD 50 for a tracking device and USD 150 for a telecom network subsystem. A medical device that transmits therefore needs the UCC certificate in addition to its NDA registration.

    Source Urls
    • https://www.ucc.co.ug/type-approval-application/
    • https://www.ucc.co.ug/wp-content/uploads/2023/10/TYPE-APPROVAL-FRAMEWORK-FOR-COMMUNICATIONS-EQUIPMENT-IN-UGANDA.pdf
    Source Binding

    reviewed

  • Id

    uganda-ucc-communications-equipment-import-approval

    Name

    UCC approval at importation or sale of communications equipment

    Category

    Telecom Network Attachment

    Status

    Mandatory At Import

    Object

    Telecom Equipment

    Note

    The same framework makes the approval a condition of importation, use or sale rather than only of connection: the Commission states that all communications equipment manufactured, imported, distributed or sold in Uganda must be type approved, and it has separately warned the public that walkie-talkies and radio calls are being imported before approval and that equipment must be type approved before it is imported, installed and operated. The framework also provides for a one-off approval granted for a single dated purpose and for exemptions for equipment temporarily imported, which are grants rather than rights. For a network-attached device the practical effect is that the approval is checked at import, so the certificate must exist before shipment.

    Source Urls
    • https://www.ucc.co.ug/type-approval-application/
    • https://www.ucc.co.ug/wp-content/uploads/2023/10/TYPE-APPROVAL-FRAMEWORK-FOR-COMMUNICATIONS-EQUIPMENT-IN-UGANDA.pdf
    Source Binding

    reviewed

Official Sources
  • Authority

    Uganda Communications Commission

    Topic

    type approval application, procedure, fees and framework for communications equipment

    Url

    https://www.ucc.co.ug/type-approval-application/

  • Authority

    Uganda Communications Commission

    Topic

    Type Approval Framework for Communications Equipment in Uganda, under the Uganda Communications Act 2013 and the Uganda Communications (Equipment Type Approval) Regulations 2019

    Url

    https://www.ucc.co.ug/wp-content/uploads/2023/10/TYPE-APPROVAL-FRAMEWORK-FOR-COMMUNICATIONS-EQUIPMENT-IN-UGANDA.pdf

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