ANMAT

Argentina - ANMAT

GuidanceLast updated · 2023Verified · 2026-10-17

Disposición 2318/02 + ANMAT cybersecurity criteria

Authority

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica

Enforced

2002 (rev. 2022)

Legal framework

Ley 16.463 + Disposición 2318/02 + PDPA Argentina (Ley 25.326)

FDA package reuse

~85%

Editorial estimate · how →

Scope

All medical devices marketed in Argentina, with SaMD and software updates increasingly under scrutiny.

Pre-market

Risk-class registration dossier; reference-jurisdiction route accepts FDA / CE / Health Canada approvals.

Post-market

Tecnovigilancia reporting to ANMAT, software change notifications.

SBOM

Recommended

Encouraged in line with IMDRF N60; not yet mandated.

Vulnerability disclosure

Encouraged via CERT.ar coordination.

Penalty

Registration cancellation, sanitary fines, criminal liability for adulteration.

Unique requirements

01Argentine Registration Holder
02Spanish-language IFU and labelling
03Mercosur GMP audit accepted

Highlights

Reference jurisdiction route shortens timelines
Spanish-language documentation throughout
Mercosur harmonisation increasing

Aligns with

IMDRF N60 Mercosur GMP ISO 13485

Timeline

2002
Disposición 2318/02 published
2022
Cybersecurity criteria added in revision

Key documents

Disposición 2318/02 ANMAT

https://www.argentina.gob.ar/anmat

How to submit in Argentina

Playbook reviewed · 2026-07-16

Submission route

ANMAT registration under Disposition 2318/2002

ANMAT accepts GHTF and MDSAP evidence. Cybersecurity documentation is not mandated separately but recommended for connected devices.

Authority portal

Step-by-step

Step 01
Appoint local representation
Most jurisdictions require a locally-established entity to hold the registration or act as authorised representative before submission.
Step 02
Reuse FDA or CE package as baseline
Adapt the cybersecurity subsection you already prepared for FDA or CE; regulators here typically accept the structure and ask for local labeling additions.
Step 03
Translate and localise
Local-language technical summary and labeling are usually mandatory; certified translation is safest.
Step 04
Submit + track queries
Respond to clarification rounds promptly; each unanswered question can add 30-90 days to the clock.

Evidence checklist

Item	Level	FDA equivalent	Notes
Cybersecurity documentation (baseline FDA or CE)	Required	SPDF
Local authorised representative agreement	Required	—
Local-language labeling and IFU	Required	—
SBOM	Recommended	—	Not mandatory but reduces clarification rounds.

Common ANMAT rejections

No local Technical Director

Common

Fix · Appoint a registered TD before submission.

Typical timeline

End-to-end window: 9-15 months

Phase 01

Local rep + dossier prep

2-4 months

Phase 02

Regulatory review

9-15 months

Phase 03

Approval + market entry

1-3 months

Related markets

Australia

~85% FDA reuse

Saudi Arabia

~85% FDA reuse

Colombia

~85% FDA reuse

United Kingdom

~80% FDA reuse

Frequently asked about Argentina

Is SBOM required for medical devices in Argentina?

Recommended. Encouraged in line with IMDRF N60; not yet mandated.

What does ANMAT require for pre-market cybersecurity?

Risk-class registration dossier; reference-jurisdiction route accepts FDA / CE / Health Canada approvals.

What are the post-market cybersecurity obligations under ANMAT?

Tecnovigilancia reporting to ANMAT, software change notifications.

What is the penalty for non-compliance with ANMAT cybersecurity rules?

Registration cancellation, sanitary fines, criminal liability for adulteration.

How much of my FDA cybersecurity package is reusable in Argentina?

Roughly 85% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).