Argentina medical device registration timeline
Source-linked clocksAdministración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) review clocks and end-to-end planning ranges, using the 4-class (I, II, III, IV) classification system.
| Class / pathway | Review clock | Planning total | With prior approval | 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 | 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 | 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 | 15 working days | 6-12 months | 4-7 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 | 110 working days | 1-1.5 years | 8-12 months | Verified |
| Class IV(Full Registration) Art. 6: Class IV runs on the same 110 administrative working days as Class III | 110 working days | 1.5-2 years | 1-1.3 years | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
Argentina Medical Device Registration Process
Step-by-step ANMAT registration process. Total estimated timeline: 1-3 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by ANMAT. Appoint a Argentina Registration Holder.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to ANMAT including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksANMAT reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0 working daysIn-depth technical assessment of device safety and performance. ANMAT may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, ANMAT issues Argentina market authorization certificate.
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
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
- 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
Reviewed 2026-08-29. End-to-end totals remain planning estimates.