ANMAT market access

Argentina medical device registration resources

Research ANMAT registration records, classification, regulations, timelines, fees, and market updates — the stable entrance to every Argentina medical device resource.

47,454 filing records11 free resources24/25 requirements covered15 regulations trackedAug 2026 fees reviewed

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Medical device registration database

Search official ANMAT device registration records.

Medical device registry insights

Explore market trends, registrations, manufacturers, and local representatives.

Medical device regulations

Browse official ANMAT regulations and guidance documents.

Government registration fees

Review current ANMAT application, review, and renewal fees.

AI registration cost and timeline planner

Estimate the likely ANMAT pathway, government fees, dossier preparation time, review timeline, and registration steps.

Medical device regulation news

Follow recent ANMAT policy, guidance, and compliance updates.

AI medical device classifier

Describe your device and get a preliminary ANMAT risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Argentina requirements.

AI similar registered product finder

Describe a device and find comparable products in the ANMAT registration database.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

Compare ANMAT statutory review periods with realistic approval times by device class.

Structured regulatory requirements

Explore all 42 source-linked facts →

24 of 25 research dimensions currently covered · 22 official sources · latest verification 2026-08-29

Market entry

D01

Authority & regime

Verified

Competent authority: ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica), a decentralized autarchic body under the Ministerio de Salud, is the competent authority for medical devices…

1 source-linked fact

Checked 2026-08-25

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D02

Legal basis & guidance

Verified

Statutory scope under Ley 16.463: Ley 16.463 subjects the import, export, production, elaboration, fractioning, marketing and warehousing of medicinal specialties and medical technology products to prior authorization and c…
Current registration framework (GMC 25/21 via Disposición 64/2025): Medical device registration is governed by MERCOSUR Resolución GMC 25/21, incorporated into Argentine law by Disposición ANMAT 64/2025 (published in the Boletín Oficial on 13 January 2025),…

3 source-linked facts

Checked 2026-08-25

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D03

Device definition & scope

Verified

Device definition (producto médico): 'Producto médico' under MERCOSUR GMC Res. 25/21 covers any instrument, apparatus, equipment, implant, in vitro diagnostic product, software, material or other article intended by the manufa…

1 source-linked fact

Checked 2026-08-25

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D04

Classification rules

Verified

Risk classes I through IV.: Class I, Class II, Class III, Class IV

1 maintained scheme

Checked 2026-08-25

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D05

Registration pathways

Verified

Registration route split by class: Registration route splits by class: Class I and II registrations, modifications and reválidas are processed under Disposición ANMAT 5706/2017 (Art. 1); Class III and IV registrations under…
IVD Groups A/B registration by Declaration of Conformity: IVDs (reactivos de diagnóstico in vitro) in Groups A and B are registered by Declaración de Conformidad (declaration of conformity), with 15 administrative working days for ANMAT to evaluat…

2 source-linked facts

Checked 2026-08-25

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D06

Reliance & recognition

Verified

MDSAP affiliate membership (QMS audit reliance): target: geo:arg · sourceApproval: Medical Device Single Audit Program · edgeType: qms audit reliance · membership: affiliate member · marketAccessStrength: evidence only · regulatoryLayer:…
Foreign-authorization dossier exemptions (Class III/IV): At inscription of a product already authorized by a foreign health authority with an equivalent regulatory framework (with official free sale certificate), the applicant is exempt from cert…

2 source-linked facts

Checked 2026-08-25

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D07

Economic-operator roles

Verified

Local market-entry role: archetype: marketing authorization holder or registrant · name: ANMAT habilitated importer/manufacturer holding the product registration · required for foreign: yes · registration relation:…

1 source-linked fact

Checked 2026-08-25

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D08

Establishment, import & distribution

Verified

BPF and habilitación certificates presented together: The establishment's BPF (Buenas Prácticas de Fabricación) certificate and its habilitación certificate must be presented jointly: the authorized scope and its validity are determined by the…
Class I/II import notice within 48 hours: Since 6 August 2025 (Disposición ANMAT 4446/25), imports of Class I and II medical devices require an AVISO DE IMPORTACIÓN (sworn declaration import notice) filed in the BONITA system up to…

3 source-linked facts

Checked 2026-08-25

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D09

Dossier requirements

Verified

Legalization/apostille of foreign documents: Foreign documents in Class III/IV registration dossiers must be legalized under the Consular Regulation or by Hague Apostille and translated by a public translator (traductor público).
Foreign registration/free-sale certificate age limit: The certificate of registration or free sale from the country of origin submitted with Class III/IV registration applications must be no older than 24 months.

3 source-linked facts

Checked 2026-08-25

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D10

Official forms & portals

Verified

Mandatory electronic filing via Sistema HELENA: Since 1 November 2017 all trámites under Disposición ANMAT 5706/2017 (Class I/II registration, modification, reválida) must be filed electronically through the Sistema HELENA; both the Dire…
ANMAT e-systems by function: Official ANMAT systems: GHEMA (habilitación of manufacturer and importer establishments), HELENA (electronic product registration, including IVDs), BONITA (import management, incl. import n…

2 source-linked facts

Checked 2026-08-25

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Submission & evidence

D11

Label, IFU & language

Verified

Label, IFU, and submission language: label ifu: Spanish · submission: Spanish; foreign documents must be legalized/apostilled and translated by a public translator · status: verified official
Mandatory label elements and registration-number format: Device labels must state, in Spanish, at least: manufacturer/importer name and address, product identification, the word 'estéril' where applicable, lot number or serial number, manufacture…

3 source-linked facts

Checked 2026-08-25

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D12

QMS, audit & inspection

Verified

QMS and audit evidence for market access: iso relation: local qms with iso evidence · local regime: BPF (Buenas Prácticas de Fabricación) per Disposición ANMAT 194/99 required for registration; BPF certificate and habilitación cert…

1 source-linked fact

Checked 2026-08-25

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D13

Standards, testing & ancillary approvals

Unresolved

ANMAT electrical/EMC evidence: Electrical safety
ENACOM homologation: Wireless / radio
RAMATEL: Wireless / radio

4 maintained overlays

Checked 2026-08-29

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D14

Fees

Verified

Registration - Class I/II family: ARS 500,220
Registration - Class III/IV family: ARS 824,985

6 maintained fee lines

Checked 2026-08-25

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D15

Review clocks

Verified

Class I (Annex II Part A) · Sworn declaration, registered on receipt: 0 working days
Class I (all other) · Declaration of Conformity: 15 working days
Class II · Declaration of Conformity: 15 working days

5 maintained pathways · 1 related fact

Checked 2026-08-29

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D16

Approval validity & renewal

Verified

Authorization duration: type: fixed term · description: 5 years; reválida (renewal) application must be filed within the last 90 days of validity
Class I/II reválida filing window: Class I and II reválida applications must be filed within the 90 days before registration expiry.

2 source-linked facts

Checked 2026-08-25

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Lifecycle & post-market

D17

Change control

Verified

Modifications keep original validity: Approved modifications and changes do not restart the registration clock: the product keeps its original 5 year validity and expiry date.

1 source-linked fact

Checked 2026-08-25

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D18

UDI, listing & traceability

Verified

National traceability system (GTIN + serie): The Sistema Nacional de Trazabilidad de Productos Médicos, created by Resolución 2175/2013, is the tool against illegitimate commerce; products are verified by GTIN (Global Trade Item Numbe…

1 source-linked fact

Checked 2026-08-25

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D19

Clinical investigation & performance

Verified

Clinical-investigation use exempt from registration: Devices intended for research or clinical trials are exempt from registration, provided the legal provisions of the competent health authority for such activities are met; commercialization…
ANMAT authorization of clinical investigations: ANMAT is the body responsible for authorizing and controlling experimental clinical investigations in medicines, food and medical products, and for issuing the governing regulation; approva…

2 source-linked facts

Checked 2026-08-25

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D20

Special access & derogation

Verified

Compassionate-use import authorization: Unregistered devices may be imported for a named patient whose disease endangers life or quality of life (uso compasivo), under individual ANMAT authorization through the TAD portal (free,…
Custom-made device registration exemption: Custom made devices (productos médicos confeccionados a medida, under the conditions of Anexo IV) are exempt from registration; they must be manufactured under BPF by habilitated establishm…

2 source-linked facts

Checked 2026-08-25

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D21

Manufacturer PMS

Verified

Post-market tecnovigilancia duty for registration holders: All holders of medical device registrations authorized by ANMAT must comply with the post market tecnovigilancia duties of Disposición ANMAT 8194/2023.
Trend reports (informes de tendencia): Registration holders must establish, elaborate, maintain and keep available to ANMAT trend reports (informes de tendencia) as part of post market surveillance.

2 source-linked facts

Checked 2026-08-25

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D22

Vigilance & incident reporting

Verified

Serious incident reporting deadlines: Any serious threat to public health must be reported within 48 hours; incidents involving death or serious deterioration of health must be notified within 10 calendar days of becoming aware.
FSCA reported within 10 days of implementation: Field safety corrective actions (FSCA) must be reported to ANMAT within 10 calendar days counted from their implementation.

3 source-linked facts

Checked 2026-08-25

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D23

Recall, FSCA & market surveillance

Verified

Field safety notice (Nota de Seguridad en Campo): Disposición ANMAT 8194/2023 provides for the 'Nota de Seguridad en Campo' (field safety notice) as the communication instrument linked to field safety corrective actions.
Market-control enforcement: nationwide lot ban: When illegitimate product is detected, ANMAT market control actions include a nationwide prohibition on use and commercialization of the involved manufacturing lot, together with traceabili…

2 source-linked facts

Checked 2026-08-25

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D24

Advertising, claims & promotion

Verified

Only authorized products may be advertised: Under Disposición ANMAT 4059/25, only products holding the corresponding authorization may be advertised. For devices, the covered scope is products authorized with the condition 'uso sin p…
Mandatory warning legend in device advertising: Advertising for medical devices must include the legend 'LEA ATENTAMENTE LAS INSTRUCCIONES DE USO. ANTE LA MENOR DUDA CONSULTE A SU MÉDICO'.

2 source-linked facts

Checked 2026-08-25

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D25

Submission communications & appeal

Verified

Reconsideration appeal within 20 days: A party may file a recurso de reconsideración (reconsideration appeal) against an ANMAT act within 20 days of notification, under the national administrative procedure regulation applicable…
Hierarchical appeal within 30 days; alzada for autarchic acts: The recurso jerárquico (hierarchical appeal) must be filed before the authority that issued the challenged act within 30 days; acts of autarchic entities such as ANMAT may also be challenge…

2 source-linked facts

Checked 2026-08-25

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Government fees

Full fee schedule (6 lines) →

ANMAT registration fees in ARS · reviewed 2026-08-25

Fee line	Amount	Provenance
Registration - Class I/II family	ARS 500,220	Verified
Registration - Class III/IV family	ARS 824,985	Verified
IVD Registration - Class A/B	ARS 445,725	Verified
IVD Registration - Class C/D	ARS 564,165	Verified

2 more fee lines on the full schedule · 6 of 6 rows source-verified

Registration timeline

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Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) review clocks and planning ranges · 4-class (I, II, III, IV) classification

Class / pathway	Review clock	Planning total	Provenance
Class I (Annex II Part A)(Sworn declaration, registered on receipt)	0 working days	1-3 months	Verified
Class I (all other)(Declaration of Conformity)	15 working days	4-6 months	Verified
Class II(Declaration of Conformity)	15 working days	6-12 months	Verified
Class III(Registration with clinical data)	110 working days	1-1.5 years	Verified