Explore the medical device requirements currently available for Uruguay, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
The advertising regime of Decreto 18/989 (propaganda limited to the approved pharmacological actions and doses; 30-day silence rule for unapproved indications) covers medicamentos and, via Art. 16, pharmaceutical products for medicinal, dental, cosmetic and dietetic use; it does not cover reactivos de diagnóstico, equipos médicos or dispositivos terapéuticos.
What expires, what is retained periodically, and when must renewal start?
Registration (registro) of a medical product is valid for 5 years.
Renewal must be requested before the Departamento de Tecnología Médica of the MSP in advance of expiry; if observations are raised there are 90 days to cure them, after which the renewal is deemed denied and the file archived. The registration certificate enables commercialisation of the products during its validity period.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Product registrations included in a certificate may be transferred to another company (Cesión de Registro) only with prior approval of the Departamento de Tecnología Médica; the transfer is definitive and keeps the validity of the original registration.
Any modification made by the manufacturer or importer must be communicated to the competent sanitary authority for the purpose of updating the registration; failure to comply with this duty is a ground for suspension of the product registration.
Which clinical or IVD performance evidence or study is required and accepted?
The dossier must describe the safety and efficacy (essential requirements) of the product; where this description does not demonstrate safety and efficacy, the sanitary authority may require clinical investigation at the charge of the importer or manufacturer.
Is the product a device, IVD, accessory, software, or borderline product locally?
Art. 1 of Decreto 3/008 establishes three categories: A) reactivos para diagnóstico (chemical or biological substances, alone or as systems, excluding reading equipment, used in vitro or in vivo to investigate a human ailment); B) equipos médicos (instruments or apparatus, mechanical, electrical, electronic or logical - including software - applied to diagnostic, biological, imaging or therapeutic ends, including spare parts, calibration/conditioning solutions and accessories); C) dispositivos (terapéuticos/médicos) (instruments, implements, implants and materials for diagnosis, prevention, monitoring, treatment or alleviation of disease, etc., whose principal action is not achieved by pharmacological or metabolic means).
Category A covers IVD-type reagents; reading equipment is excluded from A and captured under B.
Which evidence, local deltas, formats, and signatures are required?
The technical report must contain: a) detailed description of the product including operating rationale and action, composition and accessories; b) manufacturer-stated intended use/indication; c) precautions, restrictions, warnings and special care including storage and transport; d) presentation forms; e) flow diagram of manufacturing stages with a summary of each; f) description of safety and efficacy (essential requirements) - if safety and efficacy are not demonstrated, MSP may require a clinical investigation at the charge of the importer or manufacturer.
The registration file (carpeta) comprises: habilitación/registry constancia; technical specifications of the product; commercial documentation attached to the product (brochures, instructions, user manuals, warranties); certificate of free sale of the country of origin; sworn declaration of new/used/recycled status; and a solicitud form - presented per family with numbered folios, a table of contents (formulario/rótulo/CLV/información técnica folios), copies of quality certificates the company holds (if applicable) and the technical report. Free sale certificates must have the products to be registered marked on them.
Manual section 7.1 sets the folder order (PRIMERO nota ... SEXTO formulario ... SÉPTIMO información técnica); footnote: 'señalizar en el CLV de procedencia los productos a registrar'.
For medical equipment, a sworn declaration states whether the equipment is new, used or recycled with year of manufacture; used equipment requires a local recycling protocol, a copy of the free sale certificate of the country of origin, user and service manuals, and a sworn declaration by the representative detailing recycling, pre-installation, installation and after-sales capability; recycled equipment requires a management system with process traceability. Providers with expired registrations may renew once if the equipment remains operational.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
The MSP keeps a registry/habilitación of companies that are manufacturers, representatives, distributors and/or importers of the regulated medical products; under Decreto 3/008 the scope extends to companies that produce, import, store, distribute or perform repair/maintenance of such products. Foreign manufacturers therefore operate through an MSP-habilitated local company (representative/importer).
Decreto 3/008 Art. 2 restates the habilitación duty for producers, importers, storers, distributors and repairers.
Every company under Decreto 3/008 must have a responsible Director Técnico, a university professional (physician, dentist, pharmaceutical chemist, engineer or other competent professional), who evaluates products, trains staff, advises technically and co-shares responsibility for compliance; registration applications must be signed by the legal representative and the Director Técnico, and both remain responsible for the product while it remains on the market.
Which establishment licences, importer permissions, and distribution controls apply?
Companies that produce, import, store, distribute or repair/maintain medical products must be habilitated by the MSP; the habilitación is valid for five years. The trámite (form FO-13222-003) is filed in person with a note to the Minister signed by the legal representative and the Dirección Técnica, notarial certificate, Director Técnico credential, premises documentation (plans, pest control, fire brigade clearance, staff health cards) and product lists; the certificate is valid up to 5 years from the date of the Ministerial Resolution and the trámite is fee-bearing (arancelado).
Decreto 3/008 Art. 2: 'La habilitación tendrá una validez de cinco (5) años'; filing is physical plus scanned PDFs at Departamento de Administración Documental, Av. 18 de Julio 1892.
Medical products offered at public auction must be previously inspected by competent MSP personnel to determine fitness and validity for use; only authorised firms may acquire them, and the auctioneer must report buyer details to the Departamento de Tecnología Médica within five business days.
Importing equipos y dispositivos médicos requires an MSP certificate obtained through VUCE trámite TECM: either a 'certificado negativo' (product not registered) or a 'desaduanamiento' (customs clearance) which requires the company to be registered with MSP and the product to have a registration application in process; VUCE transmits the approved certificate automatically to the Dirección Nacional de Aduanas enabling entry (certificate numbers start with prefix VU).
What regulator fee applies to this class, route, event, and date?
For registration purposes the tariffs in force (aranceles vigentes) apply, i.e. the fee schedule is set outside Decreto 3/008 itself and is collected through MSP Tesorería and the VUCE trámite charges.
The TECM trámite for the MSP negative certificate / customs clearance (desaduanamiento) certificate for importing medical equipment and devices has no cost.
Which label and IFU elements, languages, symbols, and translation controls apply?
All regulated products must be labelled and carry user instructions and technical information; the labelling, in Spanish, must state: a) product name and container content; b) lot number and, where applicable, manufacturing date and expiry; c) name and address of manufacturer and importer and country of origin; d) MSP product registration number and responsible Director Técnico name; e) instructions for safe use; f) sterilisation date, method and expiry (if applicable); g) storage/conservation/handling conditions and reusable status; h) warnings. Items a) to c) must appear on the primary packaging. Equipment whose dimensions permit must bear name, address, telephone and contact details of the responsible company.
Which current law, regulation, guidance, and transition provisions apply?
Decreto N° 35/025 (promulgated 17/02/2025, published 06/03/2025) internalises MERCOSUR GMC Resolución N° 7/24 approving the 'Reglamento Técnico MERCOSUR Requisitos esenciales de seguridad y desempeño de los productos médicos y productos médicos para diagnóstico in vitro', and derogates Decreto N° 152/001 (which had internalised GMC Res. 72/98).
Decreto 3/008 Art. 8 f) still cites Decreto 152/001 in its consolidated text; that reference now points to the repealed instrument.
Decreto N° 3/008 'Requisitos para reactivos de diagnóstico, dispositivos terapéuticos y equipos médicos' (promulgated 01/01/2008, published 17/01/2008, Registro Nacional de Leyes y Decretos Tomo 1/2008 p. 9) is the operative national regulation, issued under Decreto-Ley N° 15.443 (Ley Orgánica de la Salud Pública) and modified inter alia by Decreto 87/010.
Replaced the regulation of Decreto 165/999 (9 June 1999), which MSP practice still references for information requirements.
Decreto N° 428/022 (promulgated 27/12/2022, published 20/01/2023, in force from publication) internalises MERCOSUR GMC Resolución N° 25/21 on registration of medical products and derogates Decreto N° 7/001 (which had internalised GMC Res. 40/00).
Effective from 2023-01-20
MSP - Departamento de Evaluación de Tecnología (Departamento de Tecnología Médica), División Productos de Salud
VUCE PIRM electronic transfer plus MSP product-specific forms (FO-13222 series) and the MSP 'Manual de Procedimientos - Registro de Producto'
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
The Director Técnico and the legal representative are responsible for communicating to the DTM-MSP any problem that arises during commercialisation of the products, and remain responsible for the product during the whole habilitación period and while products remain on the market.
Which current form, portal, account, and submission package must be used?
MSP publishes the FO-13222 series for technology-evaluation trámites, including: FO-13222-006 registration of equipo médico; -007 reactivo de diagnóstico; -008 dispositivo terapéutico; -009 general product registration request; -010 model registration note; -011 Class I declaration; -016 certificate of negative registration; -017 request for evaluation prioritisation; -018 change of Dirección Técnica; -019 unregistered medical products; -020 patient informed consent; plus verification checklists LV-13222-001 to -004.
The existence of FO-13222-011 'Formulario de Declaración Clase I' evidences a class-based declarative track alongside full registration.
The PIRM trámite is performed by a logged VUCE user of a VUCE-registered company (or the customs broker), using digital signature - the Uruguayan identity card with DNIC PIN or an advanced physical-person signature with token; the form must obligatorily be signed by the company's Director Técnico. Operation is started with Código de Régimen 'REGISTRO / ESPECIALES', Entidad 'Ministerio de Salud Pública', Trámite PIRM.
Corrects the baseline partial portal-surface fact with verified portal detail.
Which QMS, audit, inspection, and certificate scope is accepted or required?
The dossier is evaluated documentarily and includes copies of quality certificates held by the company only 'if applicable'; recycled equipment must have a management system with process traceability. Registered companies must exhibit, on MSP inspection: the product registration certificate, a complete copy of the registration dossier, maintenance activity records (for equipment maintainers), a copy of the registration of products commercialised with supplier/acquirer documentation (distributors), and the applicable quality certificate.
Which recall, FSCA, notice, and authority-coordination duties apply?
Where products are not fit for their intended use or may pose a danger to human health, definitive seizure is ordered and the products are destroyed at the infractor's expense.
The competent authorities will suspend the registrations of medical products where: a) non-compliance with Art. 7 literal h) (change notification) is proven, or b) there are duly justified suspicions that the product presents risks to the health of the patient, operator or third parties.
Which registration, notification, listing, reliance, or conformity route applies?
All products defined in Decreto 3/008 (diagnostic reagents, therapeutic devices, medical equipment) must be registered with the MSP; applications are submitted by companies holding a valid MSP habilitación, and registration is done by families of products.
Registration and renewal applications are filed electronically through the VUCE PIRM trámite ('PIRM - MSP - Recepción de solicitudes de registro de productos de DETM'), backed by the MSP manual dossier ('carpeta', max 20 products per folder, all within the same family) and category-specific forms.
Corrects the baseline partial fact with verified portal and form identifiers.
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.
Regulatory reference
Registration requires a certificate of free sale (certificado de libre venta, CLV) issued by the competent authority of the country of origin; where the authorities of origin do not issue it and MSP deems it pertinent, it may be replaced by a quality certificate granted by recognised bodies.
Manual (form item 5) additionally records the CLV country, expiry date and folio number with the certificates highlighted.
Prior approval / evidence record
Decreto 3/008 Art. 7 d) requires, for product registration before the Ministry of Public Health, a free-sale certificate issued by the competent body of the country of origin; if the origin authorities do not issue one and MSP deems it pertinent, it may be replaced by a quality certificate from recognized bodies. An NMPA registration/free-sale certificate is therefore the required origin document for China-made devices. The decree contains no reference-country list and no abridged review based on foreign approvals, and MSP evaluates safety and efficacy under Art. 8 f) with the option to require clinical investigation.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
uruguay
NMPA Class I filings and Class II/III certificates for all MSP product categories (reactivos de diagnóstico, equipos médicos, dispositivos médicos)
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2008-01-17
Source passage: d) certificado de libre venta emitido por el organismo competente del país de origen. En caso de que las autoridades del país de origen no lo emitieran y si el Ministerio de Salud Pública lo juzga pertinente, podrá sustituirse por certificado de calidad otorgado por organismos reconocidos;
Prior approval / evidence record
CE Mark (EU MDR)
Yes
Uruguay works from the certificate of free sale and the technical dossier behind the CE certificate. The MSP period is set by the procedure, not by where the device was approved.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
FDA 510(k)/PMA
Yes
Accepted as evidence of conformity alongside the certificate of free sale, with no published reduction.
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
What review, validation, and applicant stop-clock rules apply?
Product registrations must be authorised within a maximum of 180 days from submission of the application; if observations are issued, the period is automatically suspended and the applicants have 90 days to cure them, failing which the file is archived. (Historical note: Decreto 165/999 Art. 9 set a 40-day certificate deadline after acceptance, superseded by Decreto 3/008.)
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
The MSP official trámite surface includes 'Solicitud de ingreso de un producto médico por uso compasivo'; the forms catalogue provides FO-13222-019 'Formulario de productos medicos no registrados' and FO-13222-020 'Formulario de Consentimiento Informado para el Paciente' for such entries.
In situations of sanitary emergency declared by the Executive, the MSP may issue a provisional registration for the medical products regulated by Decreto 3/008 (diagnostic reagents, therapeutic devices, medical equipment) that are manufactured, imported, marketed or distributed in the country, under a precarious and revocable authorisation regime; MSP determines the requirements companies must meet, and the registration may be revoked at any moment if the product does not offer sufficient guarantees of safety and efficacy.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
Applicants answer MSP observations within the 90-day cure window (Art. 11); under the MSP manual, once first observations are issued the company has a maximum of 3 months to lift them or the application restarts as new, and three or more observation rounds lead MSP to consider rejecting the product; an FO-13222-017 form allows requesting prioritisation of product evaluation.
Before sanctions under Decreto 3/008 are applied (fines from a minimum of 30 Unidades Reajustables, suspension up to permanent cancellation of registration, annulment and criminal referral in case of fraud), the company is granted a period of 10 working days (vista) to respond.
Which UDI, device listing, database, and traceability duties apply?
Products must bear the MSP product registration number and the responsible Director Técnico name on the label; distributors must exhibit the registration of the products they commercialise together with documentation on their suppliers and acquirers; on questioned-product notifications the company must report units sold and buyers.
What is reportable, by whom, where, in what format, and by what deadline?
The MSP BPM portal offers separate online trámites 'Notificación de Eventos Adversos con Reactivos de Diagnóstico', 'Notificación de Eventos Adversos con Equipos Médicos' and 'Notificación de Eventos Adversos con Dispositivos Terapéuticos' (authentication required), plus a 'Registro de Comercialización de DEA/DESA por Empresas de Equipos Médicos'.
Companies commercialising the regulated products must notify the MSP and the users when they detect adverse effects or receive notifications from foreign regulators, manufacturers or national users about questioned products; the notification must include the name and registration number of the questioned products, the date of withdrawal of the product(s), units sold, buyers and other technovigilance-relevant information. Omission of this obligation is deemed fraud.
uruguay:medical-device
uruguay
MERCOSUR RTM risk classes I, II, III and IV.
Uruguay applies the MERCOSUR Reglamento Técnico de Registro de Productos Médicos (Res. GMC N° 25/21), internalised by Decreto N° 428/022, which derogated Decreto N° 7/001 (Res. GMC 40/00).
i
Clase I
low
ii
Clase II
medium
iii
Clase III
high
iv
Clase IV
highest
MSP
official-source-verified
Decreto N° 428/022, Anexo — Reglamento Técnico MERCOSUR de Registro de Productos Médicos (Res. GMC N° 25/21), Parte 2 y Apéndice II
https://www.impo.com.uy/bases/decretos-reglamento/428-2022/1
2026-08-29
Parte 2.1 classifies medical devices by intrinsic risk into clases I, II, III or IV using the rules of Apéndice II; Parte 2.2 gives the competent health authority the classification decision when the rules leave doubt; Parte 3.13 allows simplified registration procedures only for clases I and II.
Decreto N° 428/022 de 27/12/2022 (promulgación 27/12/2022, publicación 20/01/2023), arts. 1 a 3
https://www.impo.com.uy/bases/decretos/428-2022
2026-08-29
Article 1 incorporates Res. GMC N° 25/21 into Uruguayan law as an integral annex, article 2 derogates Decreto N° 7/001 of 10 January 2001, and article 3 puts the decree in force on publication in the Diario Oficial, so the RTM class axis is the current national one.
Decreto N° 428/022, Anexo (Res. GMC N° 25/21) — Parte 2 y Apéndice II
https://www.impo.com.uy/bases/decretos/428-2022
2026-08-29
Uruguay
uruguay
UY
🇺🇾
Ministry of Public Health
Ministry of Public Health
americas
3
Device registration under Decree 3/008
product-registration
Medical-device registration
MSP registration
180
180
days
7
10
months
Yes
official-verified
Uruguay Decreto 3/008 Art. 6, 11 y 13 — registro máximo 180 días, validez 5 años, renovación con 90 días para subsanar
https://www.impo.com.uy/bases/decretos/3-2008
2008-01-17
2026-08-30
registration-renewal
Registration renewal
MSP renewal
180
180
days
6
9
months
Yes
official-verified
Uruguay Decreto 3/008 Art. 6, 11 y 13 — registro máximo 180 días, validez 5 años, renovación con 90 días para subsanar
https://www.impo.com.uy/bases/decretos/3-2008
2008-01-17
2026-08-30
CE Mark (EU MDR)
Yes
Uruguay works from the certificate of free sale and the technical dossier behind the CE certificate. The MSP period is set by the procedure, not by where the device was approved.
None published
FDA 510(k)/PMA
Yes
Accepted as evidence of conformity alongside the certificate of free sale, with no published reduction.
None published
Yes
Uruguayan Authorized Representative
No
Not accepted
5 years under Decreto 3/008 Art. 6, successively revalidable for equal periods
2026-08-30
official-verified
Uruguay Decreto 3/008 Art. 6, 11 y 13 — registro máximo 180 días, validez 5 años, renovación con 90 días para subsanar
https://www.impo.com.uy/bases/decretos/3-2008
2008-01-17
2026-08-30
Uruguay Decreto 428/022 — RTM MERCOSUR GMC 25/21 Parte 3 §8: el plazo de evaluación queda remitido a la legislación de cada Estado Parte
https://www.impo.com.uy/bases/decretos-reglamento/428-2022/1
2022-12-27
2026-08-30
2026-08-30
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 Ministry of Public Health. Appoint a Uruguayan Authorized Representative.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to Ministry of Public Health including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
Ministry of Public Health 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. Ministry of Public Health may issue questions.
180 days
⚙️
5
Registration Approval
Upon successful review, Ministry of Public Health issues Uruguay market authorization certificate.
1-2 weeks
✅
uruguay
Uruguay
UY
Ministry of Public Health
0
0
UYU
Yes
0
0
UYU
Yes
current-official-fee-status
PIRM registration and MSP arancelado fees (indexed UR units)
UYU
0
PIRM: 5 UR fixed + 25 UR families + professional stamps
Check before submission
The PIRM registration trámite (VUCE/MSP) costs a fixed 5 UR per trámite plus 25 UR when families are selected; two obligatory professional stamps add to the cost. UR is an indexed unit, not a fixed peso amount.
formula-or-dynamic
official-source-only
https://vuce.gub.uy/pirm
Uruguay VUCE PIRM: registration trámite costs (UR)
2026-08-25
2026-08-25
official-source-only
Uruguay VUCE PIRM: registration trámite costs (UR)
https://vuce.gub.uy/pirm
2026-08-25
Uruguay VUCE TECM: negative-certificate / customs-clearance trámite (no cost)
https://vuce.gub.uy/tecm2
2026-08-25
Uruguay company habilitación trámite (fee-bearing, Tesorería MSP)
https://www.gub.uy/tramites/habilitacion-registro-empresas-importan-almacenan-distribuyen-productos-medicos
2026-08-25
2026-08-25
formula-or-dynamic
No
uruguay
Uruguay
high
mercosur-essential-requirements-decreto-35-025
MERCOSUR essential requirements (Decreto 35/025)
Medical Electrical Safety
Included In Medical Registration
Finished Device
Decreto 35/025 (published 06/03/2025) internalises MERCOSUR GMC Res. 7/24 essential safety and performance requirements, replacing the GMC 72/98 safety/efficacy requirements internalised by the now-derogated Decreto 152/001. No mandatory local testing overlay (electrical safety, radio, metrology, e.g. LATU) was located for registration; quality certificates are attached only 'si corresponde' and the free-sale certificate may be replaced by a quality certificate from recognised bodies when the origin country does not issue one (Decreto 3/008 Art. 7 d)).
candidate
sterile-product-sterilisation-documentation
Sterile-product sterilisation documentation
Product Specific Conformity
Included In Medical Registration
Sterile Device
Manual de Procedimientos — Registro de Producto, form item 11 'PARA PRODUCTOS ESTÉRILES': sterilisation process protocol, validation of the sterilisation process, sterility certificate and sterility test; renewals list the lots commercialised in the last two years.
reviewed
ursec-transmitter-generic-homologation
URSEC generic homologation of radio transmitters before sale
Radio Spectrum
Mandatory If Feature
Radio Transmitter
Decreto 114/003 of 25 March 2003 approves the Reglamento de Administración y Control del Espectro Radioeléctrico. Art. 33 requires every radio-communication transmitter to be generically homologated by URSEC before commercialisation and operation on the Uruguayan market, unless URSEC expressly excepts it. Homologation Types II A, II B and II C follow RF power (above 100 mW, up to 100 mW, and artisan-made). URSEC may endorse foreign-administration homologations under procedures it sets. Art. 35 lists as a grave infraction the import, manufacture, distribution, sale or installation of radiocommunication equipment that does not hold URSEC homologation. The official gub.uy procedure states the same certificate applies to any radio transmitter, including Wi-Fi/Bluetooth transmitters; that procedure page is used only as the current application surface, not as a substitute for Art. 33.
unresolved
arnr-ionizing-generator-authorization
ARNR authorisation to import and operate ionising generators
Ionizing Radiation
Mandatory If Feature
Ionizing Generator Or Radioactive Source
Ley 19.056 of 4 January 2013 Art. 6 forbids, without authorisation of the Autoridad Reguladora Nacional en Radioprotección, all activities involving ionising radiation and the import, export and transport of radioactive sources, radioisotopes or equipment that generates ionising radiation. Art. 5(D) charges ARNR with those import/export/transport authorisations and Art. 5(F) with operation licences for installations and personal authorisations for people who work with generators, plus authorisations to operate inspected equipment. Art. 3 defines equipos generadores de radiaciones ionizantes as any equipment that emits ionising radiation during operation.
reviewed
IMPO (Uruguay)
Decreto 35/025 — MERCOSUR GMC 7/24 essential requirements internalisation
https://www.impo.com.uy/bases/decretos/35-2025
IMPO (Uruguay)
Decreto 3/008 Art. 7 d) — free-sale certificate replaced by recognised-body quality certificate
https://www.impo.com.uy/bases/decretos/3-2008
GUB.UY
Manual de Procedimientos Registro de Producto — sterile-product documentation item 11
https://www.gub.uy/tramites/sites/catalogo-tramites/files/2020-10/17291575Manual%2520Registro%2520Producto%2520ver%25205%252008-07.pdf
IMPO (Uruguay)
Decreto 114/003 Reglamento de Administración y Control del Espectro Radioeléctrico Arts. 33 and 35
https://www.impo.com.uy/bases/decretos-reglamento/114-2003
IMPO (Uruguay)
Ley 19.056 Arts. 5(D), 5(F) and 6 — ARNR authorisation to import and operate ionising generators
https://www.impo.com.uy/bases/leyes/19056-2013
