ANMAT · AmericasEvery Argentina dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.
Search official ANMAT device registration records.
Explore market trends, registrations, manufacturers, and local representatives.
Browse official ANMAT regulations and guidance documents.
Review current ANMAT application, review, and renewal fees.
Estimate the likely ANMAT pathway, government fees, dossier preparation time, review timeline, and registration steps.
Follow recent ANMAT policy, guidance, and compliance updates.
Describe your device and get a preliminary ANMAT risk class with an explanation and source links.
Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Argentina requirements.
Describe a device and find comparable products in the ANMAT registration database.
Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.
Compare ANMAT statutory review periods with realistic approval times by device class.
Common questions about changing a registered medical device in Argentina. Each question separates published rules from details still awaiting verification.
24 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-09-15
ANMAT registration fees in ARS · reviewed 2026-08-25
Administración Nacional de Medicamentos, Alimentos y TecnologÃa 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) 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 | 0 working days | 1-3 months | Verified |
| Class I (all other)(Declaration of Conformity) 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 | 15 working days | 4-6 months | Verified |
| Class II(Declaration of Conformity) 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 | 15 working days | 6-12 months | Verified |
| Class III(Registration with clinical data) 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 | 110 working days | 1-1.5 years | Verified |
Newest official ANMAT headlines from the daily-refreshed feed — every row links directly to the authority publication.
ArgentinaOct 20ANANMATANMAT Lifts Operating Suspension for Medical Device Company ELECTRON PLAST S.A.ArgentinaOct 9ANANMATANMAT Issues Health Alert Reminder on Unregistered Decorative Contact LensesArgentinaOct 6ANANMATANMAT Establishes New Guidelines for Processing Good Manufacturing Practice (GMP) Certificates Abroad for Medical Devices and IVDsArgentinaSep 15ANANMATANMAT Suspends Manufacturing Activities of RIPEZZI S.R.L. and Prohibits Use of All Its Imported Medical DevicesArgentinaOfficial ANMAT rules and guidance · 15 of 15 documents linked to official sources
Computed from 47,454 official ANMAT filing records · data as of 2026-08-26
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Assess a current ANMAT update against one product and turn it into an owner-ready action workpaper.
Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Argentina (ANMAT).
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