Ministry of Public Health · Americas

Uruguay medical device regulatory resources

Every Uruguay dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

6 free resources23/25 topics with records1 regulations trackedAug 2026 fees reviewed

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Medical device regulation news

Follow recent Ministry of Public Health — Medical Technology Evaluation Department policy, guidance, safety, and compliance updates.

Registration timeline

Compare official and realistic MSP approval times by device class and pathway.

Government registration fees

Check current Ministry of Public Health fee requirements for device market entry.

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Medical device regulations

Read the MERCOSUR technical regulation internalised by Uruguay, with citeable Spanish passages.

Structured regulatory requirements

Explore all 42 source-linked facts →

23 of 25 research dimensions currently covered · 16 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified

Competent authority: Ministry of Public Health (MSP), División Productos de Salud Departamento de Tecnología Médica (currently organised as Departamento de Evaluación de Tecnología) evaluates registration appli…
Sanctioning authority: The Dirección General de la Salud (DIGESA) of the MSP exercises the sanctioning power, at the request of the Departamento de Tecnología Médica of the División Productos de Salud.

2 source-linked facts

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Essential safety and performance requirements (current): 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…
Main national regulation: 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…

4 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Regulated product categories and definitions: 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…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

MERCOSUR RTM risk classes I, II, III and IV.: Clase I, Clase II, Clase III, Clase IV

1 maintained scheme

Checked 2026-08-29

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D05

Registration pathways

Verified

Registration obligation: 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…
Market-access route and submission surface: submissionSurface: Registration and renewal applications are filed electronically through the VUCE PIRM trámite ('PIRM MSP Recepción de solicitudes de registro de productos de DETM'), backe…

2 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

China NMPA approval: origin evidence only: statement: 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…
Foreign evidence accepted at registration: 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 i…

2 source-linked facts

Checked 2026-09-15

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D07

Economic-operator roles

Verified

Company roles subject to MSP registry: 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 ex…
Director Técnico requirement: Every company under Decreto 3/008 must have a responsible Director Técnico, a university professional (physician, dentist, pharmaceutical chemist, engineer or other competent professional),…

2 source-linked facts

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

Establishment licence (habilitación): 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 00…
Public auction import controls: 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…

3 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Technical report (informe técnico): The technical report must contain: a) detailed description of the product including operating rationale and action, composition and accessories; b) manufacturer stated intended use/indicati…
Registration dossier content: The registration file (carpeta) comprises: habilitación/registry constancia; technical specifications of the product; commercial documentation attached to the product (brochures, instructio…

3 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Official forms catalogue: 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 ge…
VUCE PIRM portal mechanics: 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 ph…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Labeling and IFU in Spanish: 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 an…

1 source-linked fact

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS and inspection regime: 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 tr…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

MERCOSUR essential requirements (Decreto 35/025): Electrical safety
Sterile-product sterilisation documentation: Product-specific
URSEC generic homologation of radio transmitters before sale: Wireless / radio

4 maintained overlays

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D14

Fees

Unresolved

PIRM registration and MSP arancelado fees (indexed UR units): PIRM: 5 UR fixed + 25 UR families + professional stamps

1 maintained fee line · 2 related facts

Checked 2026-08-25

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D15

Review clocks

Verified

Medical-device registration · MSP registration: 180 days
Registration renewal · MSP renewal: 180 days

2 maintained pathways · 1 related fact

Checked 2026-08-30

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D16

Approval validity & renewal

Verified

Registration validity: Registration (registro) of a medical product is valid for 5 years.
Renewal window and consequences: 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…

2 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Registration transfer (Cesión de Registro): 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…
Post-registration change notification: 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…

2 source-linked facts

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

Traceability and listing identifiers: 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…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical evidence rule: 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 requir…

1 source-linked fact

Checked 2026-08-25

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D20

Special access & derogation

Verified

Compassionate use / unregistered product entry: 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 regis…
Emergency provisional registration: 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, therape…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-market duty of the company: 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 f…

1 source-linked fact

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Online adverse-event notification trámites: 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…
Technovigilance notification duty: 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 nation…

2 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Seizure and destruction of dangerous products: 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.
Registration suspension for risk: 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…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Advertising decree scope excludes medical products: 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…

1 source-linked fact

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Deficiency response windows and prioritisation: 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 th…
Right to be heard before sanctions: 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…

2 source-linked facts

Checked 2026-08-25

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