Explore the medical device requirements currently available for Argentina, organized by topic and linked to official sources.
Which claims, audiences, channels, approvals, and restrictions apply?
Advertising for medical devices must include the legend 'LEA ATENTAMENTE LAS INSTRUCCIONES DE USO. ANTE LA MENOR DUDA CONSULTE A SU MÉDICO'.
One of the mandatory legends listed for covered product categories.
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 prescripción' (per Art. 22 inc. c, Disposición 9688/19); self-testing IVDs (para autoevaluación) are included in the scope.
Supersedes the Disp. 4974/16-era advertising framework hinted in the brief.
What expires, what is retained periodically, and when must renewal start?
Fixed Term
5 years; reválida (renewal) application must be filed within the last 90 days of validity
GMC 25/21 annex: 'El registro de un producto médico tendrá un periodo de validez establecido por cada Estado Parte, pudiendo ser revalidado sucesivamente'.
Class I and II reválida applications must be filed within the 90 days before registration expiry.
Same 90-day window as Disp. 727/13 Art. 18 for Class III/IV.
Does the event require internal documentation, notice, prior approval, transfer, or a new application?
Approved modifications and changes do not restart the registration clock: the product keeps its original 5-year validity and expiry date.
Change events are handled as modification trámites under Disp. 5706/17 rather than new applications.
Which clinical or IVD performance evidence or study is required and accepted?
ANMAT is the body responsible for authorizing and controlling experimental clinical investigations in medicines, food and medical products, and for issuing the governing regulation; approval verifies scientific and ethical standards, licensed (matriculated) professionals and habilitated sites, with ANMAT inspection powers.
Complements the GMC 25/21 registration exemption for investigation devices.
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 and any other use are prohibited.
Effective from 2025-01-13
Clinical investigations themselves require prior ANMAT authorization per the investigaciones clínicas normativa page.
Is the product a device, IVD, accessory, software, or borderline product locally?
'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 manufacturer for medical use in humans.
Effective from 2025-01-13
Definition applied in Argentina through Disposición ANMAT 64/2025.
Which evidence, local deltas, formats, and signatures are required?
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.
Issued by the competent authority of the country of origin.
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 language documents must be accompanied by sworn translation by a public translator.
For registration of an imported device, the manufacturer's declaration may be up to 2 years old from issuance and must be legalized or apostilled; proof of registration, a free-sale certificate or an equivalent document must also be submitted.
Effective from 2025-01-13
Declaration window: 'con hasta dos (2) años desde su emisión [...] legalizada o apostillada'.
Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?
Marketing Authorization Holder Or Registrant
ANMAT-habilitated importer/manufacturer holding the product registration
yes
Holds Or Applies For Registration
Often Same
May Be Separate
Allowed Subject To Establishment Authorization
All medical-device importers without exception require ANMAT habilitación (Disposición 2319/02 t.o. 2004) and product registration; foreign manufacturers reach the market through the habilitated local company. Interprovincial IVD-reagent distributors also require ANMAT habilitación.
IVD distributor clause: 'Las empresas distribuidoras de los productos médicos reactivos de diagnóstico de uso in vitro [...] deberán contar con habilitación emitida por la ANMAT' (interprovincial sales).
Which establishment licences, importer permissions, and distribution controls apply?
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 BPF certificate, so presenting either document separately has no validity.
Original text: both certificates 'deben presentarse en forma conjunta, careciendo de validez la presentación por separado'.
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 48 hours after nationalization; the notice is free of charge and prior ANMAT import authorization for these classes was eliminated.
Effective from 2025-08-06
The notice states the regime entered into force on publication date (6 Aug 2025) and that prior intervention of ANMAT for I/II import authorization is eliminated.
Class III and IV devices, all IVDs, temporary imports of medical devices, and samples of unregistered products (any class) still require prior ANMAT import authorization. Direct users (non-profit healthcare establishments) may import any class through the TAD procedure.
Effective from 2025-08-06
Exception list published together with the Class I/II notice regime.
Which label and IFU elements, languages, symbols, and translation controls apply?
For listed implants (cardiac and vascular circulatory implants, CNS implants, spinal implants, hip and knee prostheses, breast prostheses, intraocular lenses) an implant card must carry product name/model, lot or serial number, manufacturer and importer name/address, and ANMAT registration number, with blank fields for the implanting center, implantation date and patient ID; it is issued in triplicate (patient record, patient, financing entity).
Requested 'además' (in addition) to the standard documentation for the listed implant families.
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 and expiry dates, single-use indication where applicable, storage conditions, warnings/precautions, sterilization method where applicable, the responsible technical professional, and the ANMAT registration number.
Page also requires 'Información en idioma castellano' as element 1 of the label list.
Spanish
Spanish; foreign documents must be legalized/apostilled and translated by a public translator
Verified Official
Effective from 2025-01-13
MERCOSUR rule: labels and instructions must be written in the language of the State Party where registration is sought.
Which current law, regulation, guidance, and transition provisions apply?
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), which derogates Disposiciones ANMAT 2318/02 and 1285/04.
Effective from 2025-01-13
Art. 1 incorporates Res. GMC 25/21; Art. 3 derogates the prior registration dispositions.
Ley 16.463 subjects the import, export, production, elaboration, fractioning, marketing and warehousing of medicinal specialties and medical technology products to prior authorization and control by the health authority, in establishments enabled by it.
Art. 1: 'la importación, exportación, producción, elaboración, fraccionamiento, comercialización o depósito en jurisdicción nacional'.
Disposición ANMAT 8194/2023 is the current post-market tecnovigilancia regime for medical devices, replacing Disposiciones ANMAT 8054/10 and 7485/11.
Baseline hint Disposición 4024/2005 and brief hint 4974/16-era frameworks are superseded by this regime for vigilance.
Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?
All holders of medical-device registrations authorized by ANMAT must comply with the post-market tecnovigilancia duties of Disposición ANMAT 8194/2023.
Art. 20 required holders to adapt their quality-management systems within 120 calendar days ('adecuar su sistema de gestión de calidad dentro de los 120 (ciento veinte) días corridos').
Registration holders must establish, elaborate, maintain and keep available to ANMAT trend reports (informes de tendencia) as part of post-market surveillance.
Trend reporting sits alongside incident reporting (Art. 6) and FSCA duties (Arts. 9-10).
Which current form, portal, account, and submission package must be used?
Official ANMAT systems: GHEMA (habilitación of manufacturer and importer establishments), HELENA (electronic product registration, including IVDs), BONITA (import management, incl. import notices), ARGOS (adverse-event and field-safety-corrective-action reports), THEMIS (régimen simplificado per Disposición 8799/2025).
Excerpt is the GHEMA description on the page.
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 Director Técnico and the apoderado must hold an ANMAT digital signature.
Effective from 2017-11-01
Excerpt refers to the digital-signature holders required for HELENA filings.
Which QMS, audit, inspection, and certificate scope is accepted or required?
Local Qms With Iso Evidence
BPF (Buenas Prácticas de Fabricación) per Disposición ANMAT 194/99 required for registration; BPF certificate and habilitación certificate must be presented together.
ISO 13485 is supporting evidence, not an automatic BPF waiver.
Affiliate Audit Report And Certificate Use
BPF requirement cited in both the Class II and Class III/IV dossier lists.
Which recall, FSCA, notice, and authority-coordination duties apply?
When illegitimate product is detected, ANMAT market-control actions include a nationwide prohibition on use and commercialization of the involved manufacturing lot, together with traceability tracking of units and coordination with jurisdictions.
Listed among the actions of the Departamento de Control de Mercado.
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.
Communication duty of the registration holder vis-à-vis affected users/public.
Which registration, notification, listing, reliance, or conformity route applies?
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 Disposición ANMAT 727/2013 (Art. 2), with their data modifications also under 5706/2017; IVDs under Disposición ANMAT 2198/2022. All routes end in the Registro de Productos Médicos.
Correction: baseline attributed the 15-day provision to 'some higher-risk routes'; it applies to Class I/II trámites under Disp. 5706/17.
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 evaluate the documentation.
Evaluation clock: 'un plazo de 15 (QUINCE) días hábiles administrativos para evaluar la documentación' (Art. 4).
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
class-ii
Class II
medium
Declaration of Conformity
15
15
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
6
12
months
4
7
months
No
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
Decreto 892/2025 (in force 60 days after 17 Dec 2025) and ANMAT Disposición 236/2026 create a notification-based import route for Class I and II medical devices that are authorized for public consumption in at least one country of Anexo I of the decree, and exempt such products from local testing on presentation of a free-sale certificate. Anexo I lists Australia, the EFTA countries, the EU countries, the United States, Israel, Japan and the United Kingdom; China is not included, so an NMPA certificate does not open this route.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
argentina
NMPA Class I filings and Class II certificates for devices that are ANMAT Class I/II (and IVD A/B without cold chain)
No Reliance Route
none
Product Marketing
Yes
Yes
Effective from 2026-02-15
Source passage: ARTÍCULO 2º.- ... productos médicos de clase de riesgo I y II ... siempre y cuando: 1. se encuentren autorizados para su consumo público en el mercado interno de al menos uno de los países o grupo de países que se indican en el ANEXO I (IF-2025-115076139- APN-MDYTE) del presente decreto
Prior approval / evidence record
EU CE Mark
Yes
Recognized for documentation
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
class-iv
Class IV
highest
Full Registration
110
110
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
18
24
months
12
16
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
Prior-notification import route (Decreto 892/2025 / Disposición 236/2026)
Foreign-origin Class I and II devices, and Class A/B IVDs that need no cold chain, register through a digital sworn declaration that carries the character of prior notification
Registration takes effect on filing instead of after the 15-working-day assessment
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
geo:arg
Medical Device Single Audit Program
Qms Audit Reliance
Affiliate Member
Evidence Only
Qms Audit
Yes
FDA lists ANMAT among MDSAP Affiliate Members (not full members); MDSAP audit reports/certificates serve as evidence within ANMAT processes and do not create product authorization or a BPF waiver.
Confirmed against the FDA MDSAP page; no Argentine page claims full membership.
Prior approval / evidence record
class-iii
Class III
high
Registration with clinical data
110
110
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
12
18
months
8
12
months
Yes
No
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Prior approval / evidence record
For imported Class II–IV devices, Disposición ANMAT 727/2013 Art. 3 g3) requires an authenticated copy of the registration proof issued by the competent authority of the country where the device is manufactured, issued within the previous 24 months and legalized/apostilled; for China-made devices the NMPA registration certificate is therefore a mandatory dossier document but confers no abridged review. Separately, Art. 5 allows ANMAT, at its discretion, to treat a device authorized by a foreign health authority whose regulatory functions and legislation are 'in line with' Argentina's framework as meeting similar quality/safety/efficacy characteristics and to exempt it from certain dossier items; the disposición deliberately abolished the former country list (Anexo III of Disposición 5267/06), so no official list includes or excludes China.
china
nmpa
China NMPA medical device registration certificate (Class II/III) or Class I filing record
argentina
NMPA Class II/III certificates (and Class I filing proof) for ANMAT Class II, III and IV devices
Origin Country Evidence
Evidence Only
Product Marketing
Yes
Yes
Effective from 2013-02-08
Source passage: g3) Copia autenticada del comprobante de registro otorgado por la autoridad competente, en el país donde el producto médico es fabricado con fecha de emisión no mayor a 24 meses anteriores a la presentación del expediente. ... Art. 5 — Al momento de la inscripción de un producto médico en el RPPTM autorizado por una Autoridad Sanitaria de otro país, cuyas funciones regulatorias, fiscalizadoras y legislación resulten acordes a nuestro marco regulatorio vigente ... esta Administración Nacional podrá considerar que dicho producto cumple con similares características en términos de calidad, seguridad y eficacia.
Prior approval / evidence record
FDA 510(k)
Yes
Facilitates approval process
2-4 months
Maintained reference · planning ranges remain estimates · reviewed 2026-08-29
Regulatory reference
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 certain dossier items: Art. 2 incisos f) and g) and Art. 3 incisos e), g2) and g3) of Disposición ANMAT 727/2013.
Exemptions include the local clinical evidence (Art. 2 f) and legalization-heavy foreign documentation items.
What review, validation, and applicant stop-clock rules apply?
The 15-administrative-working-day review clock for Class I/II trámites is suspended until the applicant supplies the missing information or documentation (stop-clock rule).
Base clock: 'QUINCE (15) DÍAS HÁBILES ADMINISTRATIVOS' counted from the start of the trámite.
Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?
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, fully online). The dossier includes the device history (foreign authorizations with diplomatic legalization, ongoing foreign trials), a publication indexed in Index Medicus, a risk/benefit justification signed by the treating physician and endorsed by the ethics committee, and signed informed consent; documents must be signed and stamped on every page by the responsible physician.
Definition: 'Es el uso de un producto médico para tratar una enfermedad que compromete la vida de un paciente o su calidad de vida'.
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 establishments and carry the special label (rótulo especial) conforming to the model of Anexo V.
Exemption clause: custom-made products 'quedarán exentos de inscripción'.
How are deficiencies answered, clocks handled, and decisions escalated or appealed?
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 challenged by recurso de alzada before the Ministerio de Salud.
Alzada clause (Art. 94) covers definitive administrative acts of autarchic entities.
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 to ANMAT decisions.
Deficiency responses and clock cures during review run under Disp. 5706/17 Art. 13 (stop-clock until missing documentation is supplied).
Which UDI, device listing, database, and traceability duties apply?
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 Number, the 13-digit number after (01) on the label/traceability support) plus a unique alphanumeric serie (up to 20 digits, after (21)).
What is reportable, by whom, where, in what format, and by what deadline?
Tecnovigilancia submissions must be processed through the ANMAT digital platform available for that purpose (ARGOS, the ANMAT system for adverse-event and field-safety-corrective-action reports).
ARGOS is described on ANMAT's official systems page as handling 'reportes de eventos adversos y/o acción correctiva de seguridad en campo'.
Field safety corrective actions (FSCA) must be reported to ANMAT within 10 calendar days counted from their implementation.
Clock runs from implementation of the corrective action, not from awareness.
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.
Two distinct deadlines in one article: 48 hours for grave public-health threats; 10 días corridos for death/serious deterioration.
argentina:ivd
argentina
IVD risk Groups A through D by intrinsic risk (Disposición ANMAT 2198/2022).
a
Group A
low
b
Group B
medium
c
Group C
high
d
Group D
highest
ANMAT
official-source-verified
Disposición ANMAT 2198/2022, Art. 3
https://servicios.infoleg.gob.ar/infolegInternet/anexos/360000-364999/362696/norma.htm
2026-08-25
argentina:medical-device
argentina
Risk classes I through IV.
i
Class I
low
ii
Class II
medium
iii
Class III
high
iv
Class IV
highest
ANMAT
official-source-verified
Disposición ANMAT 64/2025 — Anexo, Resolución GMC 25/21 (clasificación por reglas)
https://servicios.infoleg.gob.ar/infolegInternet/anexos/405000-409999/408309/norma.htm
2026-08-25
Argentina
argentina
AR
🇦🇷
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
ANMAT
americas
2
4-class (I, II, III, IV)
class-i-sworn-declaration
Class I (Annex II Part A)
low
Sworn declaration, registered on receipt
0
0
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
1
3
months
No
No
No
class-i
Class I (all other)
low
Declaration of Conformity
15
15
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
4
6
months
No
No
No
class-ii
Class II
medium
Declaration of Conformity
15
15
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
6
12
months
4
7
months
No
No
Yes
class-iii
Class III
high
Registration with clinical data
110
110
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
12
18
months
8
12
months
Yes
No
Yes
class-iv
Class IV
highest
Full Registration
110
110
working-days
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
18
24
months
12
16
months
Yes
No
Yes
Prior-notification import route (Decreto 892/2025 / Disposición 236/2026)
Foreign-origin Class I and II devices, and Class A/B IVDs that need no cold chain, register through a digital sworn declaration that carries the character of prior notification
Registration takes effect on filing instead of after the 15-working-day assessment
FDA 510(k)
Yes
Facilitates approval process
2-4 months
EU CE Mark
Yes
Recognized for documentation
2-4 months
Yes
Argentina Registration Holder
No
Not officially recognized but ISO 13485 helps
5 years (renewable)
2026-08-29
official-verified
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
2019-12-03
2026-08-29
Disposición ANMAT 236/2026 — prior-notification route for imported Class I/II devices and Class A/B IVDs under Decreto 892/2025
https://www.boletinoficial.gob.ar/detalleAviso/primera/338244/20260206
2026-02-16
2026-08-29
2026-08-29
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 ANMAT. Appoint a Argentina Registration Holder.
1-3 months
📋
2
Application Submission
Submit complete registration dossier to ANMAT including device description, risk analysis, and testing reports.
1-2 weeks
📤
3
Administrative Review
ANMAT 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. ANMAT may issue questions.
0 working days
⚙️
5
Registration Approval
Upon successful review, ANMAT issues Argentina market authorization certificate.
1-2 weeks
✅
argentina
Argentina
AR
ANMAT
445725
500220
ARS
Yes
564165
824985
ARS
Yes
registration-class-i-ii-family
Registration - Class I/II family
ARS
500220
ARS 500,220
Per application
exact-current
official-verified
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
2026-06-01
2026-08-25
registration-class-iii-iv-family
Registration - Class III/IV family
ARS
824985
ARS 824,985
Per application
exact-current
official-verified
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
2026-06-01
2026-08-25
ivd-registration-class-a-b
IVD Registration - Class A/B
ARS
445725
ARS 445,725
Per application
exact-current
official-verified
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
2026-06-01
2026-08-25
ivd-registration-class-c-d
IVD Registration - Class C/D
ARS
564165
ARS 564,165
Per application
exact-current
official-verified
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
2026-06-01
2026-08-25
manufacturer-importer-authorization
Manufacturer/importer authorization including GMP and technical director
ARS
1880550
ARS 1,880,550
Per authorization
exact-current
official-verified
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
2026-06-01
2026-08-25
foreign-plant-gmp-verification
Foreign plant GMP verification
ARS
11799000
ARS 11,799,000 + travel
Per main plant
Travel and additional-plant charges are separate.
exact-current
official-verified
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
2026-06-01
2026-08-25
2026-08-25
official-verified
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
2026-06-01
2026-08-25
2026-08-25
exact-current
Yes
argentina
Argentina
low
anmat-electrical-emc-evidence
ANMAT electrical/EMC evidence
Medical Electrical Safety
Included In Medical Registration
Finished Device
candidate
enacom-homologation
ENACOM homologation
Radio Spectrum
Mandatory If Feature
Radio Equipment
candidate
ramatel
RAMATEL
Radio Spectrum
Transition Not Yet Mandatory
Radio Equipment
2026-09-01
candidate
anmat-ivd-performance-test-protocol
ANMAT IVD performance test protocol
Product Specific Conformity
Included In Medical Registration
Ivd Group C Or D Device
Disposición ANMAT 2198/2022 Art. 5 governs registration applications for IVD Group C and D products; for Group D products, which require sample evaluation, the applicant must file a performance test protocol covering a minimum of 100 determinations (protocolo de ensayo para un mínimo de 100 determinaciones). Group C products are within Art. 5 but the 100-determination protocol is stated for Group D only.
reviewed
Argentina
Resolution 57/2026 and RAMATEL
https://www.argentina.gob.ar/normativa/nacional/resoluci%C3%B3n-57-2026-423392/texto
ENACOM
equipment homologation
https://www.enacom.gob.ar/homologacion-de-equipos_p347
ANMAT
Disposición 2198/2022 IVD registration and performance testing
https://servicios.infoleg.gob.ar/infolegInternet/anexos/360000-364999/362696/norma.htm
