ANMAT · structured requirements

🇦🇷 Argentina IVD regulatory data

Explore the IVD requirements currently available for Argentina, organized by topic and linked to official sources.

2 facts1 dimensions2 official sourceslatest verification 2026-09-15

Changes after registration

Common questions about changing a registered IVD in Argentina. Each question separates published rules from details still awaiting verification.

Does changing a device brand name or logo require an update? →Specific rules awaiting verification
How do I update a manufacturer's name without changing the legal entity? →Specific rules awaiting verification
What changes when the manufacturer's office address changes? →Specific rules awaiting verification
Does a catalogue or reference code change affect registration or UDI? →Specific rules awaiting verification
Can a registration transfer to a different legal entity? →Specific rules awaiting verification
Can several changes be filed together? →Specific rules awaiting verification

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

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.

Argentina approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Argentina (8 records)

ArgentinaUS FDA · EU conformity assessment

Prior approval / evidence record

Class II

class-ii

Class Name

Class II

Risk Level

medium

Pathway

Declaration of Conformity

Official Timeline

Min: 15
Max: 15
Unit: working-days

Verification Status

official-verified

Official Source

Title: Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url: https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date: 2019-12-03
Accessed Date: 2026-08-29

Realistic Timeline

Min: 6
Max: 12
Unit: months

With Prior Approval

Min: 4
Max: 7
Unit: months

Prior Approval Benefits

FDA 510(k)
EU CE Mark

Notes

Art. 5: the INPM has 15 administrative working days to assess the dossier and rule
Since 16 Feb 2026 an imported Class II device authorised in a Decreto 892/2025 Annex I country can instead use the prior-notification route, which takes effect on filing

Clinical Trial Required

Local Testing Required

Gmp Required

Yes

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaNMPA

Regulatory reference

China NMPA approval: not in Decreto 892/2025 Anexo I notification-route countries

reliance.china-nmpa-not-reference

Pending verification

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: argentina
China Classes In Scope: NMPA Class I filings and Class II certificates for devices that are ANMAT Class I/II (and IVD A/B without cold chain)
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Applies only to ANMAT Class I and II devices (and IVD A/B not requiring cold chain) of foreign origin (Decreto 892/25 Art. 2)
Alternative under Art. 2.2: certificates from official services of the country of origin or an accredited certifying body/laboratory proving compliance with the same Argentine quality/technical requirements
Anexo I may be expanded by the Secretaría de Industria y Comercio (Art. 15)
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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

ArgentinaEU conformity assessment

Prior approval / evidence record

EU CE Mark

Authority: EU CE Mark
Accepted: Yes
Benefit: Recognized for documentation
Timeline Savings: 2-4 months

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks Disposición ANMAT 236/2026 — prior-notification route for imported Class I/II devices and Class A/B IVDs under Decreto 892/2025

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaUS FDA · EU conformity assessment

Prior approval / evidence record

Class IV

class-iv

Class Name

Class IV

Risk Level

highest

Pathway

Full Registration

Official Timeline

Min: 110
Max: 110
Unit: working-days

Verification Status

official-verified

Official Source

Title: Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url: https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date: 2019-12-03
Accessed Date: 2026-08-29

Realistic Timeline

Min: 18
Max: 24
Unit: months

With Prior Approval

Min: 12
Max: 16
Unit: months

Prior Approval Benefits

FDA PMA
EU CE Mark Class III

Notes

Art. 6: Class IV runs on the same 110 administrative working days as Class III
Extensive clinical evidence and an on-site audit are possible, and art. 7 suspends the period during the deficiency response

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaSource authority not specified

Prior approval / evidence record

Prior-notification import route (Decreto 892/2025 / Disposición 236/2026)

Name: Prior-notification import route (Decreto 892/2025 / Disposición 236/2026)
Description: 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
Timeline Reduction: Registration takes effect on filing instead of after the 15-working-day assessment
Eligibility: Foreign origin
Free Sale Certificate issued no more than 24 months earlier by a Decreto 892/2025 Annex I country, which also removes local testing
Otherwise, certificates or test reports from a recognised certification body or an OAA-accredited laboratory
Importer holds the corresponding sanitary licence

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaUS FDA · EU conformity assessment

Prior approval / evidence record

Class III

class-iii

Class Name

Class III

Risk Level

high

Pathway

Registration with clinical data

Official Timeline

Min: 110
Max: 110
Unit: working-days

Verification Status

official-verified

Official Source

Title: Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url: https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date: 2019-12-03
Accessed Date: 2026-08-29

Realistic Timeline

Min: 12
Max: 18
Unit: months

With Prior Approval

Min: 8
Max: 12
Unit: months

Prior Approval Benefits

FDA 510(k)/PMA
EU CE Mark

Notes

Art. 6: ANMAT has 110 administrative working days to assess the dossier and issue the administrative act
Art. 7 suspends that period while the applicant answers the single consolidated deficiency notice, which is why the realistic range is far longer

Clinical Trial Required

Yes

Local Testing Required

Gmp Required

Yes

Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

ArgentinaNMPA

Prior approval / evidence record

China NMPA approval: origin evidence only

reliance.china-nmpa-origin-evidence

Pending verification

Statement: 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.
Source Jurisdiction Id: china
Source Authority Id: nmpa
Source Approval: China NMPA medical device registration certificate (Class II/III) or Class I filing record
Target Jurisdiction Id: argentina
China Classes In Scope: NMPA Class II/III certificates (and Class I filing proof) for ANMAT Class II, III and IV devices
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Product Marketing
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Art. 3 g3): registration proof from the country of manufacture, ≤24 months old, consular legalization or Hague apostille, sworn translation
Art. 5: discretionary exemption from Art. 2 f)/g), Art. 3 e)/g2)/g3), Art. 16 d1), Art. 17 d)/e1)/e2) when ANMAT considers the foreign framework 'acorde' and there is sufficient marketing history; requires current official certification of authorization and marketing in that country
Recital: the country list in Anexo III of Disposición 5267/06 was suppressed
Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.

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.

ArgentinaUS FDA

Prior approval / evidence record

FDA 510(k)

Authority: FDA 510(k)
Accepted: Yes
Benefit: Facilitates approval process
Timeline Savings: 2-4 months

Maintained reference · planning ranges remain estimates · reviewed 2026-08-29

Related structured datasets

Classification systems · 1 record

Open IVD risk Groups A through D by intrinsic risk (Disposición ANMAT 2198/2022). →

argentina:ivd

Jurisdiction Id

argentina

Domains

Name

IVD risk Groups A through D by intrinsic risk (Disposición ANMAT 2198/2022).

Classes

Id
a
Label
Group A
Normalized Risk Level
low
Id
b
Label
Group B
Normalized Risk Level
medium
Id
c
Label
Group C
Normalized Risk Level
high
Id
d
Label
Group D
Normalized Risk Level
highest

Regulator

ANMAT

Official Domains

argentina.gob.ar
anmat.gob.ar
infoleg.gob.ar

Source Status

official-source-verified

Source Title

Disposición ANMAT 2198/2022, Art. 3

Source Url

https://servicios.infoleg.gob.ar/infolegInternet/anexos/360000-364999/362696/norma.htm

Verified On

2026-08-25

Source Supports

ivd-class-axis

Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Argentina registration →

Country

Argentina

Jurisdiction Id

argentina

Country Code

Flag

🇦🇷

Regulator

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Regulator Abbrev

ANMAT

Region

americas

Tier

Risk Classification

4-class (I, II, III, IV)

Classes

Id
class-i-sworn-declaration
Class Name
Class I (Annex II Part A)
Risk Level
low
Pathway
Sworn declaration, registered on receipt
Official Timeline
Min
0
Max
0
Unit
working-days
Verification Status
official-verified
Official Source
Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date
2019-12-03
Accessed Date
2026-08-29
Realistic Timeline
Min
1
Max
3
Unit
months
Notes
Art. 4: Class I devices that are not sterile, have no measuring function and are not active, and appear in Annex II Part A, file a sworn declaration; the INPM endorsement at the moment of receipt is itself the RPPTM registration record, so no review period runs
The realistic range is dossier preparation and company-licensing lead time, not regulator review
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-i
Class Name
Class I (all other)
Risk Level
low
Pathway
Declaration of Conformity
Official Timeline
Min
15
Max
15
Unit
working-days
Verification Status
official-verified
Official Source
Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date
2019-12-03
Accessed Date
2026-08-29
Realistic Timeline
Min
4
Max
6
Unit
months
Notes
Art. 5: the INPM has 15 administrative working days to assess the dossier and rule
Art. 7 allows a single consolidated deficiency notice; the applicant then has 30 administrative working days to respond and the review period is suspended meanwhile
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
class-ii
Class Name
Class II
Risk Level
medium
Pathway
Declaration of Conformity
Official Timeline
Min
15
Max
15
Unit
working-days
Verification Status
official-verified
Official Source
Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date
2019-12-03
Accessed Date
2026-08-29
Realistic Timeline
Min
6
Max
12
Unit
months
With Prior Approval
Min
4
Max
7
Unit
months
Prior Approval Benefits
FDA 510(k)
EU CE Mark
Notes
Art. 5: the INPM has 15 administrative working days to assess the dossier and rule
Since 16 Feb 2026 an imported Class II device authorised in a Decreto 892/2025 Annex I country can instead use the prior-notification route, which takes effect on filing
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
Yes
Id
class-iii
Class Name
Class III
Risk Level
high
Pathway
Registration with clinical data
Official Timeline
Min
110
Max
110
Unit
working-days
Verification Status
official-verified
Official Source
Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date
2019-12-03
Accessed Date
2026-08-29
Realistic Timeline
Min
12
Max
18
Unit
months
With Prior Approval
Min
8
Max
12
Unit
months
Prior Approval Benefits
FDA 510(k)/PMA
EU CE Mark
Notes
Art. 6: ANMAT has 110 administrative working days to assess the dossier and issue the administrative act
Art. 7 suspends that period while the applicant answers the single consolidated deficiency notice, which is why the realistic range is far longer
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes
Id
class-iv
Class Name
Class IV
Risk Level
highest
Pathway
Full Registration
Official Timeline
Min
110
Max
110
Unit
working-days
Verification Status
official-verified
Official Source
Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date
2019-12-03
Accessed Date
2026-08-29
Realistic Timeline
Min
18
Max
24
Unit
months
With Prior Approval
Min
12
Max
16
Unit
months
Prior Approval Benefits
FDA PMA
EU CE Mark Class III
Notes
Art. 6: Class IV runs on the same 110 administrative working days as Class III
Extensive clinical evidence and an on-site audit are possible, and art. 7 suspends the period during the deficiency response
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
Yes

Expedited Pathways

Name
Prior-notification import route (Decreto 892/2025 / Disposición 236/2026)
Description
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
Timeline Reduction
Registration takes effect on filing instead of after the 15-working-day assessment
Eligibility
Foreign origin
Free Sale Certificate issued no more than 24 months earlier by a Decreto 892/2025 Annex I country, which also removes local testing
Otherwise, certificates or test reports from a recognised certification body or an OAA-accredited laboratory
Importer holds the corresponding sanitary licence

Prior Approvals

Authority
FDA 510(k)
Accepted
Yes
Benefit
Facilitates approval process
Timeline Savings
2-4 months
Authority
EU CE Mark
Accepted
Yes
Benefit
Recognized for documentation
Timeline Savings
2-4 months

Key Requirements

Argentina Registration Holder (for foreign manufacturers)
Technical documentation in Spanish
Free Sale Certificate
ISO 13485 certification
Spanish labeling and IFU
IVD clocks (Disposición ANMAT 2198/2022): Group A/B registration by Declaración de Conformidad 15 administrative working days; Group C/D 110 administrative working days
Post-approval clocks (Disposición 9688/2019): Class I/II modification 15 administrative working days (art. 13); Class III/IV modification 75 administrative working days (art. 15); the agile-modification list in art. 14 runs on a Declaration of Conformity; transfer of registration 50 administrative working days (art. 18)
Reválida must be started within the 30 administrative working days before expiry (art. 9); filing in time extends the existing certificate

Local Rep Required

Yes

Local Rep Name

Argentina Registration Holder

Mdsap Accepted

Mdsap Benefit

Not officially recognized but ISO 13485 helps

Registration Validity

5 years (renewable)

Last Updated

2026-08-29

Verification Status

official-verified

Official Sources

Title
Disposición ANMAT 9688/2019 (texto actualizado) — arts. 4–6 registration clocks, arts. 13/15/18 modification and transfer clocks
Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/330000-334999/332646/texact.htm
Effective Date
2019-12-03
Accessed Date
2026-08-29
Title
Disposición ANMAT 236/2026 — prior-notification route for imported Class I/II devices and Class A/B IVDs under Decreto 892/2025
Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/338244/20260206
Effective Date
2026-02-16
Accessed Date
2026-08-29

Reviewed On

2026-08-29

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by ANMAT. Appoint a Argentina Registration Holder.
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to ANMAT including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
ANMAT reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. ANMAT may issue questions.
Duration
0 working days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, ANMAT issues Argentina market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Argentina fees →

Jurisdiction Id

argentina

Country

Argentina

Country Code

Authority

ANMAT

Low Risk Local

Min: 445725
Max: 500220
Currency: ARS
Per Product: Yes

High Risk Local

Min: 564165
Max: 824985
Currency: ARS
Per Product: Yes

Details

Id
registration-class-i-ii-family
Item
Registration - Class I/II family
Currency
ARS
Amount Local
500220
Amount Local Formatted
ARS 500,220
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
Source Title
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
Source Effective Date
2026-06-01
Verified On
2026-08-25
Id
registration-class-iii-iv-family
Item
Registration - Class III/IV family
Currency
ARS
Amount Local
824985
Amount Local Formatted
ARS 824,985
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
Source Title
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
Source Effective Date
2026-06-01
Verified On
2026-08-25
Id
ivd-registration-class-a-b
Item
IVD Registration - Class A/B
Currency
ARS
Amount Local
445725
Amount Local Formatted
ARS 445,725
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
Source Title
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
Source Effective Date
2026-06-01
Verified On
2026-08-25
Id
ivd-registration-class-c-d
Item
IVD Registration - Class C/D
Currency
ARS
Amount Local
564165
Amount Local Formatted
ARS 564,165
Frequency
Per application
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
Source Title
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
Source Effective Date
2026-06-01
Verified On
2026-08-25
Id
manufacturer-importer-authorization
Item
Manufacturer/importer authorization including GMP and technical director
Currency
ARS
Amount Local
1880550
Amount Local Formatted
ARS 1,880,550
Frequency
Per authorization
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
Source Title
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
Source Effective Date
2026-06-01
Verified On
2026-08-25
Id
foreign-plant-gmp-verification
Item
Foreign plant GMP verification
Currency
ARS
Amount Local
11799000
Amount Local Formatted
ARS 11,799,000 + travel
Frequency
Per main plant
Notes
Travel and additional-plant charges are separate.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
Source Title
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
Source Effective Date
2026-06-01
Verified On
2026-08-25

Notes

Official Annex II to Disposition 2978/2026; effective 1 June 2026.
Fees can be inflation-adjusted by a later ANMAT disposition, so use the linked tariff before payment.
Registrations also carry an annual maintenance charge (tasa anual): the last published maintenance tariff (Disposición ANMAT 5634/2024, 2023 period) was ARS 39,500/52,000/70,000/93,000 per Class I/II/III/IV for marketed devices and ARS 45,500/64,000/81,500/118,500 for not-marketed devices; the current maintenance amounts sit in the 2978/2026 annexes and supersede those figures.

Last Updated

2026-08-25

Verification Status

official-verified

Official Sources

Title
ANMAT Disposition 2978/2026 and downloadable Annex II tariff schedule
Url
https://www.boletinoficial.gob.ar/detalleAviso/primera/342122/20260519
Effective Date
2026-06-01
Accessed Date
2026-08-25

Reviewed On

2026-08-25

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

Open Argentina certifications →

Slug

argentina

Market

Argentina

Confidence

low

Schemes

Id
anmat-electrical-emc-evidence
Name
ANMAT electrical/EMC evidence
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Source Urls
https://servicios.infoleg.gob.ar/infolegInternet/anexos/360000-364999/362696/norma.htm
Source Binding
candidate
Id
enacom-homologation
Name
ENACOM homologation
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Source Urls
https://www.enacom.gob.ar/homologacion-de-equipos_p347
Source Binding
candidate
Id
ramatel
Name
RAMATEL
Category
Radio Spectrum
Status
Transition Not Yet Mandatory
Object
Radio Equipment
Effective Date
2026-09-01
Source Urls
https://www.enacom.gob.ar/homologacion-de-equipos_p347
Source Binding
candidate
Id
anmat-ivd-performance-test-protocol
Name
ANMAT IVD performance test protocol
Category
Product Specific Conformity
Status
Included In Medical Registration
Object
Ivd Group C Or D Device
Note
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.
Source Urls
https://servicios.infoleg.gob.ar/infolegInternet/anexos/360000-364999/362696/norma.htm
Source Binding
reviewed

Official Sources

Authority
Argentina
Topic
Resolution 57/2026 and RAMATEL
Url
https://www.argentina.gob.ar/normativa/nacional/resoluci%C3%B3n-57-2026-423392/texto
Authority
ENACOM
Topic
equipment homologation
Url
https://www.enacom.gob.ar/homologacion-de-equipos_p347
Authority
ANMAT
Topic
Disposición 2198/2022 IVD registration and performance testing
Url
https://servicios.infoleg.gob.ar/infolegInternet/anexos/360000-364999/362696/norma.htm