Explore the medical device requirements currently available for Uganda, organized by topic and linked to official sources.
Common questions about changing a registered medical device in Uganda. Each question separates published rules from details still awaiting verification.
Which claims, audiences, channels, approvals, and restrictions apply?
NDA's medical-devices page prohibits advertising registered professional-use-only devices unless the advertisement is distributed only to qualified practitioners or appears in a publication intended for them.
Authority webpage, independently reviewed in R217.
NDA's medical-devices page places responsibility for compliance with device advertisement and promotion regulation and guidelines on the advertiser, and requires advertisement or promotional material to be submitted to NDA for vetting. 'Advertisement' is defined as the publication, dissemination or conveyance of any information for the purpose of promotion and the sale or use of the medical device by any means or in any form — including newspapers, periodicals, posters or notices, circulars and brochures, letters, photographs or films, broadcast and internet media, and public demonstration of device use.
The page displays a vetting email inconsistent with the authority domain. No unverified email destination is published in this fact.
What expires, what is retained periodically, and when must renewal start?
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.
Effective from 2014-03-28
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 [...].
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
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.
Effective from 2014-03-28
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.
What local class follows from which rules and decisive product facts?
The NDA surgical-instrument registration guideline groups medical devices into four risk classes: A (low), B (low-to-moderate), C (moderate-to-high) and D (high). Classification uses the technical rules in Appendix VII; where more than one rule applies, the highest applicable class is used.
English original, DAR/GDL/028; classification facts are scoped to medical devices covered by this guideline.
Which clinical or IVD performance evidence or study is required and accepted?
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.
Effective from 2020-08-14
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.
Is the product a device, IVD, accessory, software, or borderline product locally?
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.
Effective from 2014-03-28
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.
Which evidence, local deltas, formats, and signatures are required?
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.
Effective from 2020-08-14
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.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
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.
Effective from 2020-08-14
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.
Which label and IFU elements, languages, symbols, and translation controls apply?
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.
Effective from 2014-03-28
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.
Which current law, regulation, guidance, and transition provisions apply?
The National Drug Authority's operative registration guideline for devices is DAR/GDL/028 Rev 0, 'Guidelines on Registration of Surgical Instruments and Appliances', issued by the Directorate of Product Assessment and Registration. Its revision block records Revision Date 6 Aug 2020, Effective Date 14 Aug 2020 and Review Due Date 14 Aug 2023 — i.e. the review date had passed before this verification and the document is still the version NDA publishes. The guideline states its own legal basis: Act Cap. 206 s. 64(g), and a surgical-instruments statutory instrument whose art. 25(1) and (2) require all surgical instruments and appliances to be registered before sale or distribution. It is the instrument that carries the registration tracks, the dossier tables, the appendices and the IMDRF Essential Principles checklist.
Effective from 2020-08-14
Read in full (52 pp., 121,273 characters of text layer) from the official NDA URL via the Bright Data Web Unlocker. The revision block quoted in the excerpt is the running footer of the document and is identical on every page. Section 1.4.2's mis-citation of the statutory instrument is reproduced verbatim in the guideline; the correction is stated in conditions, not silently applied.
The statutory basis for medical-device regulation in Uganda is the National Drug Policy and Authority Act, Cap. 206. Section 64(g) empowers the Minister responsible for health to make regulations 'regulating, restricting or prohibiting the importation, sale or advertising of surgical instruments and appliances'. S.I. 2014 No. 29, the National Drug Policy and Authority (Registration) Regulations, 2014, is made under sections 35 and 64 of that Act and applies expressly to the registration of surgical instruments (reg. 2(c)); its Part III (regs. 24-35) is the device Part. The instrument does not use the words 'medical device': the statutory term of art is 'surgical instrument', defined in reg. 24 to include appliances, in-vitro reagents and calibrators and software.
Effective from 2014-03-28
The excerpt joins two passages from the same instrument, separated by the marker [...]: reg. 2 (Application) and the making clause printed under the title '(Made under Sections 35 and 64 of the National Drug Policy and Authority Act, Cap. 206)'. The Act s. 64(g) quotation is in the value and was read from the NDA-hosted Act PDF. Round 204 left the S.I. number open; this resolves it from the gazetted text itself.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
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.
Effective from 2014-03-28
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.
Which current form, portal, account, and submission package must be used?
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.
Effective from 2014-03-28
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.
Which QMS, audit, inspection, and certificate scope is accepted or required?
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.
Effective from 2023-09-06
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.
Which recall, FSCA, notice, and authority-coordination duties apply?
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.
Effective from 2014-03-28
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.
Which registration, notification, listing, reliance, or conformity route applies?
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).
Effective from 2020-08-14
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.
Which foreign decisions or evidence can be reused, with what effect and conditions?
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.
No linked record is currently maintained. This does not establish that a pathway is unavailable.
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
Yes
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.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
China NMPA registration certificate
No
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.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
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'.
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
Qms Audit Reliance
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
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.
Prior approval / evidence record
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.
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
Eligibility Gate
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
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.
Prior approval / evidence record
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.
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
Origin Country Evidence
Evidence Only
Premarket Review
Yes
Yes
Effective from 2020-08-14
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'.
Prior approval / evidence record
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.
Australia: TGA GMPALS licence or CE mark; Canada: appliance licence; European Union: CE mark; Japan: MHLW appliance licence; United States: FDA 510(k) letter
Abridged Or Recognition Route
facilitated
Premarket Review
Yes
Yes
Effective from 2020-08-14
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.
Prior approval / evidence record
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
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.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
Recognised-country certification or CE certification — an eligibility gate for classes B, C and D
Yes
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.
Maintained reference · planning ranges remain estimates · reviewed 2026-09-16
Prior approval / evidence record
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.
none
No Reliance Route
none
Premarket Review
Yes
Yes
Effective from 2020-08-14
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.
What review, validation, and applicant stop-clock rules apply?
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.
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.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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.
Effective from 2020-08-14
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.
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.
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.
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;'.
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.
Effective from 2020-08-14
Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?
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.
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).
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.
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 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.
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.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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.
Effective from 2020-08-14
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.
Which UDI, device listing, database, and traceability duties apply?
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.
Effective from 2014-03-28
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 [...].
What is reportable, by whom, where, in what format, and by what deadline?
NDA's medical-devices regulatory page requires every company dealing in medical devices — importers, manufacturers, suppliers and registrants — to report adverse events of their products. Reportable AEs follow a report-if-in-doubt disposition and three criteria: an AE (or potential AE) occurred, the device is associated with it, and it results in a serious threat to public health, the death of a patient, user or other person, or a serious deterioration in health (including an initial non-serious AE that could lead to death or serious injury on recurrence). Reporting channels: the WHO UMC primary-reporting portal (https://primaryreporting.who-umc.org/Reporting/Reporter?OrganizationID=UG), the NDA med-safety mobile app on Google Play, or the toll-free line 0800 101 999.
Reporting URL verified from the HTML href: OrganizationID=UG. Markdown emphasis introduced a spurious trailing underscore in the previous value. No reporting deadline is asserted.
uganda:medical-device
uganda
NDA Classes A, B, C and D
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.
a
Class A
low
b
Class B
medium
c
Class C
high
d
Class D
highest
NDA
official-source-verified
NDA medical devices page - registration tracks and the registration precondition
https://www.nda.or.ug/medical-devices/
2026-09-16
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.
Guidelines on Registration of Surgical Instruments / Appliances, R0 2020, Appendix VII classification rules and Table 1
https://www.nda.or.ug/wp-content/uploads/2022/02/Guidelines-on-Registration-of-Surgical-Instruments_R0_2020_Final.pdf
2026-09-16
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to a medical device.
Uganda
uganda
UG
🇺🇬
National Drug Authority (NDA)
NDA
africa
3
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
surgical-instruments-registration
Surgical instruments and appliances — registration by the Authority
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))
60
60
days
official-verified
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
https://www.nda.or.ug/wp-content/uploads/2022/03/Drug-Registration-Regulation.pdf
2026-09-16
2
6
months
No
No
Yes
Licence or approval from an IMDRF founding-member country — Australia, Canada, the European Union, Japan, the United States
Yes
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.
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
Yes
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.
Recognised-country certification or CE certification — an eligibility gate for classes B, C and D
Yes
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.
China NMPA registration certificate
No
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.
Yes
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.
No
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.
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.
2026-09-16
partially-verified
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
https://www.nda.or.ug/wp-content/uploads/2022/03/Drug-Registration-Regulation.pdf
2026-09-16
2026-09-16
default
planning-template
Maintained planning steps and estimates, not verified regulator deadlines.
1
Pre-Submission Preparation
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..
1-3 months
📋
2
Application Submission
Submit complete registration dossier to NDA including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
NDA reviews application for completeness. May request additional documents or clarifications.
2-4 weeks
🔍
4
Technical Evaluation
In-depth technical assessment of device safety and performance. NDA may issue questions.
60 days
⚙️
5
Registration Approval
Upon successful review, NDA issues Uganda market authorization certificate.
1-2 weeks
✅
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to a medical device.
uganda
Uganda
UG
NDA
200
1500
USD
No
200
1500
USD
No
registration-imported-device
Application for registration of imported surgical instruments and appliances
USD
1500
USD 1500
Per application
Schedule Part 1 item 1(e). The fee for first registration of an imported device.
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
registration-locally-manufactured-device
Application for registration of locally manufactured surgical instruments and appliances
USD
200
USD 200
Per application
Schedule Part 1 item 1(f). The same register entry as an imported device, at a lower fee.
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
annual-retention-imported-device
Retention of imported surgical instruments and appliances on the Register
USD
200
USD 200
Per year
Schedule Part 1 item 2(e). Registration is not perpetual: the device stays on the Register only while retention is paid.
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
annual-retention-locally-manufactured-device
Retention of locally manufactured surgical instruments and appliances on the Register
USD
100
USD 100
Per year
Schedule Part 1 item 2(f).
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
major-amendment-imported-device
Major amendment of an application to register an imported surgical instrument or appliance
USD
500
USD 500
Per amendment
Schedule Part 3. A notification of amendment is charged separately at a lower amount.
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
minor-amendment-imported-device
Minor amendment of an application to register an imported surgical instrument or appliance
USD
200
USD 200
Per amendment
Schedule Part 3.
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
notification-of-amendment
Notification of amendment
USD
50
USD 50
Per notification
Schedule Part 3. The cheapest post-registration change route.
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
examination-of-surgical-instruments
Examination of surgical instruments and appliances by the Authority in the course of performing its functions
USD
1000
USD 1000
Per batch
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%.
exact-current
official-verified
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
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)
2025-10-01
2026-09-16
2026-09-16
official-verified
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)
https://www.nda.or.ug/wp-content/uploads/2025/10/National-Drug-Authority-Fees-regulations-2025.pdf
2025-10-01
2026-09-16
2026-09-16
exact-current
Yes
These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to a medical device.
uganda
Uganda
low
uganda-ucc-equipment-type-approval
UCC type approval of communications equipment
Radio Spectrum
Mandatory Pre Market
Radio Equipment
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.
reviewed
uganda-ucc-communications-equipment-import-approval
UCC approval at importation or sale of communications equipment
Telecom Network Attachment
Mandatory At Import
Telecom Equipment
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.
reviewed
Uganda Communications Commission
type approval application, procedure, fees and framework for communications equipment
https://www.ucc.co.ug/type-approval-application/
Uganda Communications Commission
Type Approval Framework for Communications Equipment in Uganda, under the Uganda Communications Act 2013 and the Uganda Communications (Equipment Type Approval) Regulations 2019
https://www.ucc.co.ug/wp-content/uploads/2023/10/TYPE-APPROVAL-FRAMEWORK-FOR-COMMUNICATIONS-EQUIPMENT-IN-UGANDA.pdf
