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🇺🇬 Uganda medical device regulatory data

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

31 facts20 dimensions12 official sourceslatest verification 2026-09-16

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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A first registration certificate is valid five years and a renewal certificate one year

validity.five-year-certificate-and-annual-renewal
Fact-level verified

Under S.I. 2014 No. 29 the term of a device registration is finite. The Authority issues a certificate of registration for a first registration which is valid for five years; the holder must pay an annual retention fee prescribed by the Authority for maintaining the registered product on the Register; and a certificate for renewal of registration is valid for one year from the date of issue. A renewal application must be submitted to the Authority at least 90 days before the expiry of the registration, in writing, and must be accompanied by a consolidated report of the changes made with respect to the registered product during the validity of its registration whether or not those changes were reported to the Authority, a report of additional adverse drug reactions detected during the lifetime of the registered product, five samples of the packaging in the form in which it is to be marketed, and the prescribed fee. The certificate must be kept at the premises of the holder.

Conditions
  • This is a NEW KEY recording evidence that contradicts the existing row validity.indefinite-registration-with-annual-retention. That row states, on DAR/GDL/028 s. 4.7, that registration 'remains valid unless it is suspended, revoked or terminated' and does not record any five-year or one-year term. The statutory instrument fixes terms; both texts remain in force and are printed by NDA, so the two are recorded side by side rather than one being overwritten.
  • Reg. 40(6) preserves the guideline's language in parallel: the registration of a product 'shall be valid except where the registration is suspended or cancelled by the Authority or is terminated by the holder of the certificate of registration'.
  • DAR/GDL/028 s. 4.8 allows the registrant to terminate a registration by giving 30 days' written notice and reasons to the Authority, and allows the Authority to suspend or revoke a registration, or amend its conditions, by giving reasons in writing.
  • DAR/GDL/028 s. 4.14 expresses maintenance of registration status as subject to consistent quality and satisfactory performance on the market, and to payment of an annual retention fee.
  • The certificate of registration may itself carry terms and conditions, including tests to be performed to maintain safety and efficacy requirements and the requirement to submit the results of any tests performed.

Effective from 2014-03-28

DAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and Appliances

Contradiction recorded, not silently overwritten, per the round-209 coordinator's rule. The existing key validity.indefinite-registration-with-annual-retention is left in place and untouched: it is an accurate reading of DAR/GDL/028 s. 4.7, which does say the registration remains valid unless suspended, revoked or terminated, and its round-204 note recorded that the guideline text was read from an Internet Archive capture because nda.or.ug was unreachable. Reading the gazetted statutory instrument directly shows the guideline's 'remains valid' language sits alongside a five-year first term and one-year renewals, which the earlier row does not carry. A reviewer should treat this key as the more complete statement of validity and renewal and the earlier row as the guideline-level statement of termination conditions. Excerpt joins reg. 40(1)-(3) with reg. 42(1) verbatim, separated by [...].

Authority & regime

Which authority and binding regime govern this product, task, and date?

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The National Drug Authority is the competent authority that registers surgical instruments and appliances

authority.nda-competent-authority
Fact-level verified

S.I. 2014 No. 29 makes the National Drug Authority the registering authority for surgical instruments in Uganda: every surgical instrument must be registered by the Authority before sale or distribution in Uganda, and the Authority registers the instruments that meet the safety and efficacy standards it determines. The Authority's device remit is registration, licensing of manufacturers/importers/suppliers, GMP inspection of local and foreign manufacturing sites, labelling approval, advertising vetting, adverse-event receipt and suspension of registrations. NDA regulates the import, manufacture, export and supply of medical devices, and states that it does so under a ministerial decree ADM.140/323/01 of 20 July 2020 together with a Surgical Instruments and Appliances Regulation.

Conditions
  • The Authority is a body corporate established by the National Drug Policy and Authority Act, Cap. 206; s. 35 and s. 64 of that Act are the enabling powers cited by S.I. 2014 No. 29.
  • NDA's own device page cites the instrument stack inconsistently (a 2019 Surgical Instruments and Appliances Regulation, S.I. 77; DAR/GDL/028 cites 'Statutory Instrument No-29 ... 2017'; INS/GDL/047 cites the 2019 Regulations reg. 20(5)); see legal-basis.ndpa-act-and-regulations for the instrument-stack contradiction.

Effective from 2014-03-28

National Drug Policy and Authority Act, Cap. 206 (Laws of Uganda)Medical Devices — National Drug Authority

Read in full from the NDA-hosted PDF of S.I. 2014 No. 29 (Uganda Gazette No. 18 Vol. CVII, 28 March 2014, 166,307 characters of text layer) via the Bright Data Web Unlocker; nda.or.ug answers direct curl/browserless/WebFetch with a Cloudflare 'Just a moment...' 403 challenge. The 'regulates the import, manufacture, export and supply of medical devices' wording and the ADM.140/323/01 decree reference are quoted from the NDA Medical Devices page, which is why it is a supporting source rather than a new fact: the fact's only content is not the authority's name.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Variations are filed on Appendix V and must be applied for before the change is made

change.variation-filed-on-appendix-v
Fact-level verified

Whenever a holder of a certificate of registration wishes to make an amendment or alteration to the particulars provided in the application for registration, the holder must apply to the Authority for amendment or alteration of the registration (reg. 39(1)). The application must be accompanied by a detailed description of the amendment or alteration to be effected with reasons for it, where applicable samples of the altered product, and the prescribed fee (reg. 39(2)). DAR/GDL/028 s. 4.10 requires the application for variation of a registered surgical instrument or appliance to be made using Appendix V, and requires the National Drug Authority to be informed of any significant change — a 'significant change' being defined in reg. 24 as a change that could reasonably be expected to affect the safety or effectiveness of a surgical instrument. NDA's Medical Devices page states the same duty for registered devices generally: inform NDA of any changes to a registered medical device currently through a Variation application.

Conditions
  • 'Significant change' is statutorily defined as a change that could reasonably be expected to affect the safety or effectiveness of a surgical instrument (reg. 24), which bounds the notification duty.
  • The variation application must state reasons for the amendment or alteration and, where applicable, include samples of the altered product.
  • The application attracts the prescribed fee.
  • The consolidated report of changes submitted with a renewal application must include changes whether or not they were reported to the Authority, which is the enforcement backstop for unreported variations.

Effective from 2014-03-28

DAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and AppliancesMedical Devices — National Drug Authority

Excerpt joins reg. 39(1) and reg. 39(2)(a)-(c) verbatim with the s. 4.10 Appendix V sentence, separated by [...]. The gazetted reg. 39(2) contains a duplicated word ('shall be shall be accompanied by'), reproduced as printed.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical evidence and a clinical evaluation are required per the IMDRF Essential Principles; human-subject investigations follow Helsinki

clinical.clinical-evidence-and-investigation-requirements
Fact-level verified

Uganda routes clinical requirements through the IMDRF Essential Principles checklist that DAR/GDL/028 Appendix II adopts. Essential Principle 7.0 provides that every medical appliance requires clinical evidence, appropriate for the use and classification of the appliance, demonstrating that the appliance complies with the applicable provisions of the essential principles, and that a clinical evaluation should be conducted. Essential Principle 18.1 provides that clinical investigations on human subjects should be carried out in accordance with the spirit of the Helsinki Declaration, which includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results. Operationally, DAR/GDL/028 s. 4.3.2(i) lists 'Performance & Safety clinical studies (where applicable, upon request)' among the registration requirements for high-risk surgical instruments and appliances, and s. 4.12.3(c) requires a Track 3 applicant to file 'Summary information on pre-clinical design verification and validation' as Appendix I item 2 part p. NDA's classification page points to the UNBS webstore for the surgical-instrument standards it applies.

Conditions
  • The Essential Principles are adopted via the DAR/GDL/028 Appendix II conformity checklist, which the applicant must complete as evidence of conformity for classes B, C and D.
  • Performance and safety clinical studies are required where applicable and upon request, not as a routine stand-alone submission.
  • Track 3 applicants must file pre-clinical design verification and validation summary information (Appendix I no. 2 part p) in place of a track-checklist clinical submission.
  • No device-specific clinical-investigation application form, authorisation route or approval timeline was located; the Conduct of Clinical Trials Regulations 2024 published by NDA is an image-only scan and could not be read, so it is not relied on here.

Effective from 2020-08-14

S.I. 2014 No. 29 — The National Drug Policy and Authority (Registration) Regulations, 2014 (Uganda Gazette No. 18 Vol. CVII, 28 March 2014)Classify Your Medical Device — National Drug Authority

New fact: no Uganda row existed for D19. Excerpt is Essential Principles 7.0 and 18.1 verbatim, joined by [...]. The appendix is a flattened IMDRF Essential Principles table reproduced in the guideline and carries an 'Applicable to the appliance?' / 'Method of Conformity' / 'Identity of Specific Documents' column set which the text extraction renders inline; the principle text itself is quoted without those column labels. The Conduct of Clinical Trials Regulations 2024 is named in conditions only to record what could not be read, not as evidence.

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.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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A separate complete dossier per instrument, with class A and class B/C/D content sets

dossier.class-based-technical-documentation
Fact-level verified

A separate and complete dossier in electronic form must be submitted for each surgical instrument, appliance, group or family. DAR/GDL/028 s. 4.3.3.1 sets out two content sets. For class A the dossier is the filled application form (Appendix I), a letter of authorization, the IFU/patient information leaflet and promotion material including brochures and catalogues, labelling information, information on sterilization methods and validation standards where applicable, and proof of a quality management system such as an ISO 13485 certificate. For classes B, C and D the dossier is the filled application form, a letter of authorization, information on appliance details, a summary of technical documentation, labelling information, evidence of conformity to the Essential Principles / Essential requirements checklist (Appendix II), and proof of a quality management system such as an ISO 13485 certificate. The statutory application particulars are listed in reg. 27(4) of S.I. 2014 No. 29 (items (a) to (l)), and DAR/GDL/028 s. 4.3.2 lists the substantive technical requirements for high-risk instruments, including manufacturing process and flowchart, contract-manufacturer relationship letters and technical agreements, ICH zone IV stability studies, laboratory QC analysis files, performance and safety clinical studies where applicable, distribution status and English leaflet and labelling artwork.

Conditions
  • The dossier requirements are said to differ by class, labelling and presentation route, not by registration track: 'The dossier for surgical instruments and appliances (whether for listing or registration) will differ in requirements, as these requirements are based on the class and labelling and not on the route of registration it will follow.'
  • A representative label may suffice for groups of more than five versions, on an undertaking letter that labels are identical apart from the differentiating factor (unit size, pack size, software version), with the differentiating parts highlighted.
  • A representative sample for each product category must accompany the company registration dossier, together with the required certificates for each appliance; exemption from sample submission can be requested for large or very expensive appliances, in which case the product catalogue and/or sample viewing may be considered.
  • Where the manufacturer of any step differs from the legal manufacturer or authorised representative in the country of origin, authenticated relationship letters from the contract manufacturer and the technical agreement must be provided, and the contract manufacturer must be registered with a separate file submitted by the Market Authorisation Holder.
  • Performance and safety clinical studies are required where applicable and upon request.

Effective from 2020-08-14

S.I. 2014 No. 29 — The National Drug Policy and Authority (Registration) Regulations, 2014 (Uganda Gazette No. 18 Vol. CVII, 28 March 2014)

Excerpt is the s. 4.3.3.1 requirement sentence plus the two column headings and their first rows verbatim; the table was flattened by text extraction into two columns and is reproduced here in reading order, which is why the excerpt reads as interleaved lists. The statutory particulars list in reg. 27(4) is summarised in the value rather than quoted, and is carried by the supporting source.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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An authorised local technical representative must declare responsibility for every application

operator.local-technical-representative
Fact-level verified

S.I. 2014 No. 29 reg. 27(3) lists who may apply: the patent holder, a licensed person, the manufacturer of the surgical instrument, or an agent authorised by the manufacturer or patent holder. It does not require the applicant to be resident in Uganda. The operative local-actor requirement is instead in DAR/GDL/028 s. 4.3.1: a declaration by the authorised local technical representative of the applicant must be submitted for all applications, undertaking (a) to ensure all submitted documents are an accurate reflection of truth, collected and compiled through the right and legal channels, authenticated by signature and stamping of their source; (b) to be fully responsible for the product and the post-market plan submitted for complaint handling or recall; and (c) to comply fully with NDA's requirements after placing the product on the market. The local technical representative is also the party that must submit corrected artwork where NDA requires labelling changes, and where NDA requires new artwork the product will not get marketing approval until the Local Technical Representative in Uganda submits it with a sample from the first consignment.

Conditions
  • The declaration must accompany all applications, not only high-risk ones.
  • The local technical representative is accountable for complaint handling and recall, which localises the D23 obligations onto a Ugandan actor.
  • Where NDA requires labelling changes, the Local Technical Representative in Uganda must submit the new artwork together with a sample from the first consignment that conforms to the approved labelling and packaging artwork.
  • Company registration documents must be submitted at the same time as the registration file of the first product; subsequent files from the same manufacturer need not repeat them.

Effective from 2020-08-14

S.I. 2014 No. 29 — The National Drug Policy and Authority (Registration) Regulations, 2014 (Uganda Gazette No. 18 Vol. CVII, 28 March 2014)

Excerpt is the s. 4.3.1 declaration passage verbatim. The regulation's own applicant list (reg. 27(3)) is quoted in the value from a second instrument; it is deliberately described as not requiring residence, because the regulation does not say so and the guideline does not either — the residence requirement is a practice-level inference and is not asserted here.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

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Nine mandatory label elements, to be provided in English, permanently and prominently

label.english-labelling-requirements
Fact-level verified

Reg. 29(1) of S.I. 2014 No. 29 requires the applicant to submit with the registration application a label carrying: the name of the surgical instrument; the name and address of the manufacturer; the identifier of the surgical instrument, including the identifier of any instrument or appliance that is part of a system, test kit or group; an indication of package contents where they are not readily apparent (size, net weight, length, volume or number of units); the word 'Sterile' if the manufacturer intends the device to be sold in a sterile condition; the expiry date where applicable, determined on the basis of the component with the shortest projected useful life; the medical conditions, purposes and uses for which it is manufactured, sold or represented, including performance specifications necessary for proper use, unless self-evident to the intended user; the directions for safe and effective use, unless directions are not required; and any special storage conditions. Reg. 29(2) requires that information to be provided in English, in a permanent and prominent manner, in terms easily understood by the intended user. Reg. 35 adds that where a surgical instrument or appliance is intended to be sold to the general public, the reg. 29(1) information must be set out on the outside of the package and be visible under normal conditions of sale, and where the package is too small, the directions for use must accompany the device.

Conditions
  • English is mandatory and is the only language specified: reg. 29(2) requires the information 'in English', with no additional national-language requirement.
  • The guideline adds a tenth item, the batch number / lot number / identification number, required to appear on the label under DAR/GDL/028 s. 4.4.1(j).
  • DAR/GDL/028 s. 4.4 requires the labelling information to be in English, permanent and prominent, legible, and in terms easily understood by the intended user; s. 4.4.2 and s. 4.4.3 restate the general-public and small-package rules.
  • English leaflet and labelling artwork must conform to the country-of-origin marketing approval, and if NDA requires changes the product will not get marketing approval until the Local Technical Representative in Uganda submits the new artwork with a sample from the first consignment.
  • The approved artwork and design are attached to the registration certificate where applicable.

Effective from 2014-03-28

DAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and Appliances

Excerpt is reg. 29(2) and reg. 35(1)-(2) verbatim, joined by [...]; the nine label elements of reg. 29(1) are enumerated in the value rather than quoted in full to keep the excerpt to a size that can be checked line by line. Reg. 29(1) contains a typographical error in the gazetted text ('Subject to subregualtion (2)' in reg. 35(1)), reproduced here as printed.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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The certificate holder must monitor safety and effectiveness and file periodic reports; annual PMS reports for high-risk products

pms.annual-post-marketing-surveillance-reports
Fact-level verified

S.I. 2014 No. 29 reg. 40(5) places a continuing market obligation on the holder of a certificate of registration: the holder 'shall monitor the safety and effectiveness of the registered ... surgical instrument while on the market in Uganda and shall submit periodic reports as may be prescribed by the Authority'. Reg. 42(2) makes that obligation concrete at renewal, requiring the renewal application to be accompanied by a consolidated report of the changes made with respect to the registered product during the validity of its registration — whether or not those changes were reported to the Authority — and a report of additional adverse drug reactions detected during the lifetime of the registered product. DAR/GDL/028 s. 4.7 conditions the continuing validity of registration on submission of annual post-marketing surveillance reports for those products NDA defines to be of high risk or to require special attention, and on submission of adverse-effect reports for products classified as class D. DAR/GDL/028 s. 4.14 expresses maintenance of registration status as subject to consistent quality and satisfactory performance of the product on the market and to payment of the annual retention fee.

Conditions
  • The annual post-marketing surveillance report duty in DAR/GDL/028 s. 4.7 is bounded to products NDA defines as high risk or as requiring special attention; the adverse-effect report duty in the same section is bounded to class D.
  • The statutory periodic-report duty in reg. 40(5) is not itself frequency-bounded: it says reports 'as may be prescribed by the Authority'.
  • The renewal file must include changes whether or not they were reported to the Authority, so the consolidated report operates as a catch-all disclosure.
  • The local technical representative declares responsibility for the post-market plan submitted for complaint handling or recall (DAR/GDL/028 s. 4.3.1(b)).
  • Maintenance of registration is also conditioned on payment of an annual retention fee prescribed by the Authority.

Effective from 2014-03-28

DAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and Appliances

Excerpt joins reg. 40(5) with reg. 42(2)(a)-(b) verbatim, separated by [...]. The statutory text says 'adverse drug reactions' rather than 'adverse device events' because S.I. 2014 No. 29 is a drug instrument that was extended to surgical instruments by reg. 2(c); the wording is reproduced as printed rather than paraphrased.

Official forms & portals

Which current form, portal, account, and submission package must be used?

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Form 7 (Schedule 6) is the device application form; Form 8 is the certificate; DAR/GDL/028 adds Appendices I-VII

forms.application-form-7-and-appendices
Fact-level verified

The device application form is Form 7, prescribed by reg. 27(2) of S.I. 2014 No. 29 as Schedule 6 to those Regulations: 'APPLICATION FORM FOR THE REGISTRATION OF SURGICAL INSTRUMENTS', printed under the heading 'NATIONAL DRUG POLICY AND AUTHORITY ACT, CAP 206'. The certificate of registration is Form 8, prescribed by reg. 30(2) as Schedule 7. The format of the register of surgical instruments is Schedule 5, prescribed by reg. 26. DAR/GDL/028 wraps the statutory form set in its own appendices: Appendix I is Form 7 with the product and manufacturer detail and the submission checklist, Appendix II is the IMDRF Essential Principles conformity checklist, Appendix III is Form 8, Appendix IV is the register format, Appendix V is the form for variation of a registered surgical instrument or appliance, and Appendix VI is the application submission checklist. NDA publishes the current downloadable form set on its Application Forms page, which lists the application form for the registration of surgical instruments, the application form for variation/alteration of a registered surgical instrument/appliances, the Essential Principles checklist for registering surgical instruments and appliances, and the classification rules for surgical instruments and appliances.

Conditions
  • Form 7 is prescribed by Schedule 6; the certificate (Form 8) by Schedule 7; the register format by Schedule 5.
  • Variations are made on Appendix V of DAR/GDL/028, not on a statutory schedule.
  • The current live form set is published as documents from the NDA Application Forms page rather than being reproduced inside the regulations; the guideline appendices and the page entries must be read together.
  • Licence applications (as distinct from product registration) are submitted online through the NDA portal at https://portal.nda.or.ug/.

Effective from 2014-03-28

Application Forms — National Drug AuthorityDAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and Appliances

Excerpt is the arrangement-of-schedules entries and the Schedule 6 header block verbatim, joined by [...]. The DAR/GDL/028 appendix letters are taken from the guideline's own cross-references (Appendix I in s. 4.13 and s. 4.2, Appendix II in s. 4.3.3.1, Appendix III in s. 4.5, Appendix IV in s. 4.6, Appendix V in s. 4.10, Appendix VI in s. 4.13) and from the appendix headings themselves. The NDA Application Forms page names each document in the live set and is the supporting source; it was read from the saved page text, not merely cited.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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NDA recognises ISO 13485:2016 as the basis for cGMP, and inspects all local and foreign manufacturers

qms.acceptable-quality-system-standards-and-inspection
Fact-level verified

NDA recognises the medical-devices quality management systems requirements of the ISO 13485:2016 standard as the basis for the regulated medical devices current good manufacturing practices (cGMP), but compliance with ISO 13485:2016 does not replace the Authority's regulatory requirement of cGMP. INS/GDL/047 Rev 0, effective 6 September 2023, sets out the cGMP requirements for design and development, manufacture, storage, distribution, installation or servicing of surgical instruments and appliances, and forms the basis of GMP inspection by NDA as one of the requirements for registration in Uganda. Its scope is expressly extraterritorial: the guidelines are to be used for GMP inspections of all local and foreign manufacturers of surgical instruments and appliances whose products are registered or subjected to registration in Uganda, and they establish requirements applicable to manufacture including in vitro diagnostics. DAR/GDL/028 Table 3 separately lists the quality system standards NDA accepts from the five IMDRF founding member countries, and s. 4.3.1 provides that a pre-registration GMP inspection or quality system audit may be conducted as part of evaluation of a surgical instrument or appliance.

Conditions
  • ISO 13485:2016 recognition is stated as the basis for cGMP; it is not a substitute, and cGMP remains a separate regulatory requirement.
  • Acceptable quality system standards by country (DAR/GDL/028 Table 3): ISO 13485 or ISO 13488 for Australia, Canada and the European Union; GMP QS Standard for medical appliances #1128 for Japan; QS 21 CFR part 820 for the United States.
  • A pre-registration GMP inspection or quality system audit may be conducted as part of the evaluation of an application.
  • INS/GDL/047 states its basis as the National Drug Policy and Authority (Surgical Instruments & Surgical appliances) Regulations, 2019, regulation 20(5): 'The Authority shall, ascertain that the manufacturing facility complies with accepted GMP guidelines adopted by the Authority.'

Effective from 2023-09-06

DAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and Appliances

Read in full from the NDA-hosted PDF of INS/GDL/047 Rev 0 (Revision Date 28 Aug 2023, Effective Date 6 Sep 2023, Review Due Date 6 Sep 2026; 68,627 characters of text layer) via the Bright Data Web Unlocker. Excerpt joins the ISO 13485 recognition sentences and the scope sentence verbatim, separated by [...]. Note the standard-year discrepancy inside the source: the recognition sentence says 'ISO 13485:2016' but the next sentence says 'ISO 13485: 2016' with a stray space; both spellings are reproduced as printed where quoted.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

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The manufacturer determines recalls and NDA may suspend a registration with notice and a hearing

recall.holder-responsibility-and-authority-suspension
Fact-level verified

On the manufacturer's side, INS/GDL/047 s. 7.1.1.8 requires the manufacturer to determine product recalls and other field actions that are relevant for products already distributed, s. 7.1.1.7 requires relevant information on quality issues and on preventive and corrective actions to be submitted to the competent health authority when applicable, and s. 7.2.1.2 requires complaints to be notified to the competent health authority when applicable. DAR/GDL/028 s. 4.3.1(b) makes the authorised local technical representative fully responsible for the post-market plan submitted for complaint handling or recall. On the Authority's side, reg. 31(1) of S.I. 2014 No. 29 allows NDA to suspend a registration by giving the holder written notice stating the reason, and reg. 31(2) requires suspension where the holder has contravened the Regulations or the Act, made a false or misleading statement in the application, failed to comply with the terms and conditions of the certificate, or where the instrument no longer meets the safety and efficacy standards NDA determines. Before suspending, NDA must consider the holder's compliance record and whether maintaining the registration would injure health or safety, and must give written notice of intention to suspend setting out the reason, the corrective action required and the time to take it (reg. 31(3)); it may not suspend before that time has elapsed or without giving the holder an opportunity to be heard (reg. 31(4)). Reg. 32 carves out an exception: NDA may suspend without a hearing where necessary to prevent injury to the health or safety of patients, users or other persons. Reg. 33 allows reinstatement where the situation that caused the suspension is corrected or the reason was unfounded, and DAR/GDL/028 s. 4.8 additionally allows NDA to revoke a registration or amend its conditions by giving reasons in writing.

Conditions
  • Four statutory grounds for suspension: contravention of the Regulations or the Act; a false or misleading statement in the application; non-compliance with the terms and conditions of the certificate; or the instrument no longer meeting NDA's safety and efficacy standards.
  • Suspension normally requires written notice of intention, a stated corrective action and a time to take it, and an opportunity to be heard; reg. 32 removes the hearing only where necessary to prevent injury to health or safety.
  • The registrant may also terminate a registration by giving NDA 30 days' written notice and reasons (DAR/GDL/028 s. 4.8(ii)).
  • The manufacturer's recall duty is a cGMP obligation binding on all local and foreign manufacturers whose products are registered or subject to registration in Uganda (INS/GDL/047 s. 1.2.4).

Effective from 2014-03-28

INS/GDL/047 Rev 0 — Guidelines on Good Manufacturing Practice for Surgical Instruments and AppliancesDAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and Appliances

Excerpt is reg. 31(1)-(2) and reg. 32 verbatim, joined by [...]. The recall wording ('determine product recalls and other field actions') is quoted in the value from INS/GDL/047, which is the only instrument that uses the word recall for devices; the statutory instrument regulates suspension and revocation instead. That split is why the supporting source carries the recall limb rather than a second fact being created.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

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Three NDA tracks distinguish founding-IMDRF licensing, accepted quality-system or WHO evidence, and manufacturer conformity declarations

registration.three-registration-tracks
Fact-level verified

Registration is mandatory before sale or distribution, and an application is made before manufacture, importation or exportation (reg. 25(1), reg. 27(1)). NDA operates three registration tracks, defined in DAR/GDL/028 s. 4.12 and restated on NDA's Medical Devices page: Track 1 for products licensed in an IMDRF founding-member country (Australia, Canada, European Union, Japan, United States); Track 2 for products not licensed in an IMDRF country but holding documented conformity to a quality system standard from a certification body accredited by an IMDRF regulatory authority, or WHO Prequalification, or another international organisation recognised by NDA; Track 3 for products with no certification to any of the accepted quality system standards, which must instead carry a Manufacturer's Declaration of Conformity to the IMDRF Essential Principles of Safety and Performance and pre-clinical design verification and validation information. The application is made on Form 7 (Schedule 6 to S.I. 2014 No. 29; Appendix I to DAR/GDL/028). All applications and supporting documents must be typed in English, and where original copies are in another language they must be presented with a certified English translation (s. 4.2).

Conditions
  • Track 1 applicants must file a notarized copy of the licence in the IMDRF founding-member country, a Certificate of Analysis confirming compliance to an accepted quality system standard, and evidence of repeat sales in the country of manufacture.
  • Track 2 requires documented evidence of conformity from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA.
  • Track 3 requires a Manufacturer's Declaration of Conformity to the IMDRF Essential Principles of Safety and Performance, or equivalent, plus a summary of pre-clinical design verification and validation.
  • Applications are processed either for expedited registration with a notice of listing, or for review by the Technical Committee which upon approval grants a certificate of registration.

Effective from 2020-08-14

S.I. 2014 No. 29 — The National Drug Policy and Authority (Registration) Regulations, 2014 (Uganda Gazette No. 18 Vol. CVII, 28 March 2014)Medical Devices — National Drug Authority

Excerpt joins the s. 4.12 heading and the three track headings verbatim, separated by [...]. The review clock in reg. 38(1) (60 days) and the six-month query rule are deliberately not asserted in this fact's value: review clocks are a typed dataset (D15) and are out of scope for this round. Read in full from the NDA-hosted PDF via the Bright Data Web Unlocker.

Reliance & recognition

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

Compare countries

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 (10 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

UgandaWHO · IMDRF member authorities · ISO

Prior approval / evidence record

Track 2: WHO Prequalification or QMS certification from an IMDRF-accredited body substitutes for an IMDRF-country licence

reliance.track-2-who-prequalification-or-imdrf-accredited-qms
Fact-level verified
Statement

A product that is not licensed in an IMDRF founding-member country can still enter Track 2 by producing documented evidence of conformity to an accepted quality system standard from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, or WHO Prequalification, or any other international organisation recognised by NDA. This is a documentary substitution: the foreign element that unlocks the route is the quality-system certification and its accreditation, not a product approval. NDA's Medical Devices page states the same route for products 'prequalified by WHO or registered in SRA countries'.

Source Approval

WHO Prequalification, or ISO 13485/ISO 13488 (or the country-equivalent QS) certification issued by a certification body accredited by a regulatory authority in an IMDRF founding-member country; more broadly, registration in a country NDA treats as a stringent regulatory authority

Edge Type

Qms Audit Reliance

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Track 2 requires documented evidence of conformity from a certification body accredited by a regulatory authority in one of the IMDRF founding member countries, OR WHO Prequalification, OR any other international organisation recognised by NDA.
  • A Certificate of Analysis confirming compliance to a quality system standard in Table 3 must also be filed.
  • The accepted standards in DAR/GDL/028 Table 3 are ISO 13485 or ISO 13488 (Australia, Canada, European Union), GMP QS Standard for medical appliances #1128 (Japan) and QS 21 CFR part 820 (United States).
  • Track 2 still requires evidence of repeat sales in the country of manufacture and a completed submission checklist, and NDA retains the registration decision.

Effective from 2020-08-14

Medical Devices — National Drug Authority

edgeType 'qms_audit_reliance' is reused from the existing vocabulary (4 prior uses): the mechanism is reliance on a third party's quality-system certification rather than on a product approval. NDA's page wording for this route ('Track 2 for Products prequalified by WHO or registered in SRA countries') is carried by the supporting source. The guideline does not define 'SRA'; the page's SRA language and the guideline's 'accredited by a regulatory authority in one of the IMDRF founding member countries' are not identical, and the fact is bounded to what the guideline says.

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

Prior approval / evidence record

For classes B, C and D, certification from a recognised country (or CE certification) is mandatory; only class A may be exempted

reliance.reference-country-or-ce-certification-mandatory-classes-b-d
Fact-level verified
Statement

Uganda treats recognised-country certification as an eligibility gate, not merely as evidence. DAR/GDL/028 s. 4.11 states that devices not certified by any of the recognised countries will be examined and may be exempted from recognised-country certification only if they are class A; for other classes the recognised-country or CE certification is a must. The recognised countries are the United States (FDA clearance/approval), Canada, Japan (MHLW clearance/approval) and Europe. For Europe the certificate required scales with class: full quality assurance / EC Type Examination Certificate for class B and C, and full quality assurance / EC Design Examination Certificate for class D, and the notified body must itself be approved by European health authorities.

Source Approval

US FDA clearance/approval; Canada clearance/approval; Japan MHLW clearance/approval; Europe EC quality-system certification with an EC Type Examination Certificate (class B and C) or EC Design Examination Certificate (class D) issued by a notified body approved by European health authorities

Edge Type

Eligibility Gate

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Applies to appliances classified B, C or D; a class A appliance may be examined and exempted from recognised-country certification if appropriate.
  • Evidence must be provided as original authenticated documents.
  • For Europe the certificate type is class-dependent: EC Type Examination Certificate for class B and C, EC Design Examination Certificate for class D.
  • The notified body must be approved officially by European health authorities and the committee will ask for documented evidence of the notified body's registration or licensing.
  • This gate sits above the track structure: an uncertified class B/C/D product cannot fall back to Track 3, because Track 3 still requires a Manufacturer's Declaration of Conformity rather than third-party certification, and s. 4.11 makes recognised-country or CE certification a must for those classes.

Effective from 2020-08-14

Medical Devices — National Drug Authority

Excerpt is a contiguous verbatim run from s. 4.11 with the class-by-class European detail joined by [...]. edgeType 'eligibility_gate' is reused from the existing vocabulary (1 prior use) rather than inventing a token: the mechanism is that recognised certification is a precondition for classes B-D, which is what that token means. marketAccessStrength is 'facilitated' rather than 'evidence_only' because holding the certificate changes which applications can be accepted at all, not just how much paperwork is filed. There is an internal tension in the source between s. 4.11 (certification is a must for classes B-D) and s. 4.12.3 (Track 3 for products with no certification to any listed quality system standard); both are recorded, and the tension is stated in conditions rather than resolved by assumption.

UgandaSource authority not specified

Prior approval / evidence record

A legalised country-of-origin marketing approval is a mandatory dossier item for high-risk surgical instruments

reliance.country-of-origin-marketing-approval-mandatory
Fact-level verified
Statement

For surgical instruments or appliances classified or considered high risk, the applicant must submit a legalised approval issued by a health authority in the country of origin to market the product in the relevant country (a certificate of conformity, or any equivalent), together with all certificates or documents issued by an assessment body as evidence of regular approval or clearance. This is a mandatory dossier item and is distinct from the IMDRF reference-country route: the country of origin need not be an IMDRF founding member, but its marketing approval must exist and must be legalised.

Source Approval

Any marketing approval, certificate of conformity or equivalent issued by the health authority of the country of origin, legalised; plus certificates or documents issued by an assessment body as evidence of regular approval or clearance in the country of origin

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Expressed in DAR/GDL/028 s. 4.3.2 as a requirement for 'surgical Instruments or appliances classified or considered high risk', subdivided by sterile or non-sterile presentation.
  • The approval must be legalised and submitted as an authenticated document.
  • Evidence of repeat sales in the country of manufacture is required separately under s. 4.3.2(n) and the track checklists.
  • Applies in addition to, not instead of, the recognised-country or CE certification gate in s. 4.11 for classes B-D.

Effective from 2020-08-14

S.I. 2014 No. 29 — The National Drug Policy and Authority (Registration) Regulations, 2014 (Uganda Gazette No. 18 Vol. CVII, 28 March 2014)

edgeType 'origin_country_evidence' (46 prior uses) is the exact token for this mechanism: the origin-country approval is required paperwork and the full local review still runs, hence marketAccessStrength 'evidence_only' rather than 'facilitated'.

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

Prior approval / evidence record

Track 1: an IMDRF founding-member licence opens an abridged evaluation (Australia, Canada, EU, Japan, USA)

reliance.imdrf-reference-country-licence-track-1
Fact-level verified
Statement

A device already licensed in one of the IMDRF founding-member countries goes into Track 1, which NDA describes as an expedited review with shortened registration timelines whose evaluation process is abridged by the foreign approval. The applicant does not re-submit the full technical dossier: Track 1 requires a covering attestation, abbreviated product and manufacturer details, a notarized copy of the IMDRF-country licence, a Certificate of Analysis confirming compliance to an accepted quality system standard, evidence of repeat sales in the country of manufacture, product samples where practicable, and a completed submission checklist. The approval recognised is the one listed for the country in DAR/GDL/028 Table 2.

Source Approval

Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The recognised approval is country-specific: DAR/GDL/028 Table 2 names GMPALS licence or CE mark for Australia, an appliance licence for Canada, CE mark for the European Union, an appliance licence for Japan, and a 510K appliance letter for the United States.
  • Track 1 still requires a national application on Form 7 and NDA retains the registration decision; the foreign licence abridges the evaluation, it does not replace the registration.
  • Track 1 additionally requires a Certificate of Analysis confirming compliance to a quality system standard from DAR/GDL/028 Table 3 (ISO 13485 or ISO 13488 for Australia, Canada and the EU; GMP QS Standard for medical appliances #1128 for Japan; QS 21 CFR part 820 for the United States) and evidence of repeat sales in the country of manufacture.
  • CE-marked products enter track 1 via the European Union founding-member entry; there is no separate CE-only track.

Effective from 2020-08-14

Medical Devices — National Drug Authority

Excerpt joins the s. 4.12.1 heading with items (d) and (e) of the same list and with Table 2 verbatim, separated by [...]. NDA's Medical Devices page restates the same mechanism in its own words for the customer question: '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.' That page sentence is the supporting source's contribution and is why this is not marked source-backed-partial.

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

UgandaNMPA

Prior approval / evidence record

China NMPA approval is not on the recognised-country list and opens no route of its own

reliance.china-nmpa-no-recognition-route
Fact-level verified
Statement

Uganda's recognised-country list is closed and does not include China. DAR/GDL/028 s. 4.11 enumerates the recognised countries as the United States, Canada, Japan and Europe; Table 2 names Australia, Canada, the European Union, Japan and the United States; and NDA's Medical Devices page names 'Australia, Canada, European Union countries, Japan, and the United States'. A China NMPA registration therefore does not by itself put a product into Track 1 and does not satisfy the s. 4.11 certification gate for classes B-D. The applicable track depends on the device's qualifying approvals and evidence, not its manufacturing country alone. A Chinese-manufactured device holding a qualifying recognised-country approval may use Track 1. The separate country-of-origin approval document requirement remains applicable.

Source Approval

none

Edge Type

No Reliance Route

Market Access Strength

none

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • This is an enumeration-derived negative: it rests on the recognised-country lists being closed, not on an express exclusion of China anywhere in the instruments.
  • China is not named in DAR/GDL/028 at all; the guideline's reference list cites the China Food and Drug Administration (2014) Regulations for the Supervision and Administration of Medical Devices as a background reading, which is a bibliography entry and not a recognition provision.
  • The separate origin-country requirement in s. 4.3.2(c) is unaffected: a Chinese health-authority marketing approval is still required as a dossier item, it simply carries no abridgement.

Effective from 2020-08-14

Medical Devices — National Drug Authority

Upgraded from source-backed-partial: round 204 recorded this negative from the same lists but could not read the document directly. The lists are closed enumerations ('the recognized countries below', 'the IMDRF founding member countries') and the excerpt quotes them, which is what makes the bounded negative verifiable. This entry deliberately does not repeat round 204's earlier framing, which described the s. 4.11 gate in terms of 'China NMPA' rather than the closed list; the value here is bounded to the list itself. NDA's page list omits Australia's GMPALS detail and the guideline's Table 2 omits nothing, so the three citations are consistent.

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?

Compare countries

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?

Compare countries

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?

Compare countries

'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.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

A written objection to a registration decision may be filed with NDA; refusals must give reasons and a hearing

appeal.written-objection-to-a-registration-decision
Fact-level verified

DAR/GDL/028 s. 4.9 provides the appeal route for devices: any objection to a decision of the registration in relation to any application for registration or listing of a surgical instrument or appliance can be submitted in writing to NDA, and after consideration of the representations NDA may approve registration or listing, or if not satisfied may reject the application. The statutory instrument supplies the procedural guarantees. Where NDA is not satisfied with the information provided in an application it must require the applicant to provide further information necessary to complete the application (reg. 38(3)), and where it does not accept an application it must communicate its decision and the reasons for refusal to the applicant (reg. 38(4)). Where NDA refuses to issue, amend or alter a certificate of registration it must notify the applicant in writing of the reasons for the refusal and give the applicant an opportunity to be heard (reg. 41(2)). On suspension, NDA must give written notice of intention setting out the reason, the corrective action required and the time within which it must be taken (reg. 31(3)(c)), and may not suspend before that time has elapsed or without giving the holder an opportunity to be heard (reg. 31(4)). DAR/GDL/028 s. 4.3.1 adds a procedural sanction for silence: once a query or request has been raised the processing halts until a response is received, and if no response is received within six months from the written query notification date the application may be cancelled or rejected.

Conditions
  • The objection is filed in writing with NDA; the guideline describes no further tribunal, board or judicial step, and no appeal deadline is stated.
  • Reg. 41(2) requires reasons in writing plus an opportunity to be heard on a refusal to issue, amend or alter a certificate.
  • The six-month silence rule in DAR/GDL/028 s. 4.3.1 is a cancellation/rejection ground, not a decision that can be appealed under s. 4.9 — the guideline's own remedy for it is a fresh application.
  • Grounds on which NDA may refuse under reg. 41(1) include non-compliance with the Regulations or the Act, failure to meet the safety and efficacy standards, insufficient information or samples where the applicant does not comply with a request for more, a false or misleading statement in the application, and non-compliant labelling.

Effective from 2020-08-14

S.I. 2014 No. 29 — The National Drug Policy and Authority (Registration) Regulations, 2014 (Uganda Gazette No. 18 Vol. CVII, 28 March 2014)

Excerpt is DAR/GDL/028 s. 4.9 verbatim joined to reg. 41(2) of the statutory instrument, separated by [...]. The appeal route itself is in the guideline rather than the regulation, which is why the guideline is the primary source and the regulation is supporting: the regulation supplies the duty to give reasons and a hearing but does not name an objection procedure.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

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A device identifier must appear on the label, and the manufacturer must use serial or batch identification; no UDI database exists

udi.device-identifier-on-label-no-udi-database
Fact-level verified

Uganda imposes label-level device identification and manufacturer record-keeping, not a UDI system. Reg. 29(1)(c) of S.I. 2014 No. 29 requires the label to carry 'the identifier of the surgical instrument, including the identifier of any surgical instrument or appliance that is part of a system, test kit or group', and DAR/GDL/028 s. 4.4.1(j) adds the batch number / lot number / identification number. INS/GDL/047 s. 6.4 requires each manufacturer to establish and maintain procedures for identifying components, manufacturing materials, intermediate products and finished products during all stages of storage, production, distribution and installation, and to identify each unit, batch or lot of products with a serial or batch number, recorded in the device history record. The traceability records NDA itself keeps are the register of surgical instruments and appliances maintained under reg. 26 in the Schedule 5 format, and it is to be available on the NDA website. No UDI rule, UDI issuing agency designation or UDI database was found in S.I. 2014 No. 29, DAR/GDL/028, INS/GDL/047 or on NDA's Medical Devices page.

Conditions
  • The identifier requirement is a labelling-content requirement and a manufacturer record-keeping duty; it is not a submission of UDI data to a database.
  • The 'no UDI database' element is an enumeration-derived negative resting on the four instruments and one NDA page examined for this round, as recorded in the excerpt's companion locators and in the unresolved entry for D18.
  • The register of surgical instruments and appliances is maintained by NDA in the Schedule 5 / Appendix IV format and is to be available on the NDA website.
  • The batch, lot or identification number is an additional label element in DAR/GDL/028 that does not appear in the statutory list at reg. 29(1).

Effective from 2014-03-28

INS/GDL/047 Rev 0 — Guidelines on Good Manufacturing Practice for Surgical Instruments and AppliancesDAR/GDL/028 Rev 0 — Guidelines on Registration of Surgical Instruments and Appliances

Upgraded in place. The existing row asserted the label-identifier requirement and the 'no UDI database' negative on DAR/GDL/028 s. 4.4.1 alone and could not read the document directly. Reading the statutory instrument and the GMP guideline directly adds two hard elements the earlier row lacked: the reg. 29(1)(c) statutory basis, and the s. 6.4.2 serial/batch identification duty recorded in the device history record. The 'no UDI database' element is retained but explicitly bounded as an enumeration-derived negative over the four instruments examined, rather than stated as an institutional fact. Excerpt joins reg. 29(1)(c) with the INS/GDL/047 s 6.4 identification sentence, separated by [...].

Related structured datasets

Classification systems · 1 record
Open NDA Classes A, B, C and D →
Id

uganda:medical-device

Jurisdiction Id

uganda

Domains
  • medical-device
Name

NDA Classes A, B, C and D

Description

Uganda's four-class risk axis, from Class A (low risk) to Class D (high risk, where the risk relates to the patient or to public health). Classification is risk based and the applicant applies the guideline's classification rules to the device's intended purpose.

Classes
  • Id

    a

    Label

    Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D

    Normalized Risk Level

    highest

Regulator

NDA

Official Domains
  • nda.or.ug
Source Status

official-source-verified

Reference Sources
  • Title

    NDA medical devices page - registration tracks and the registration precondition

    Url

    https://www.nda.or.ug/medical-devices/

    Reviewed On

    2026-09-16

    Supports

    The page states that all medical devices for importation and supply must be registered before they can be supplied in Uganda regardless of track or risk class, and describes the three tracks by which NDA processes a device application. Note on retrieval: nda.or.ug refuses automated retrieval (HTTP 403 to curl, to WebFetch and to the text proxy) and the Internet Archive replay of the NDA PDFs is truncated at the crawl cap, so these two URLs were read and verified in the round-204 extraction, whose locators and quoted passages are carried here unchanged.

Source Title

Guidelines on Registration of Surgical Instruments / Appliances, R0 2020, Appendix VII classification rules and Table 1

Source Url

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

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
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
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
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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