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Argentina Medical Device Registration

Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) approval timelines and requirements

4-6 months

Typical Timeline

Device Classes

MDSAP Accepted

Required

Argentina Registration Holder

Argentina Medical Device Registration Overview

Argentina medical device registration through ANMAT typically takes 4-6 months for Class I devices. The official ANMAT target is 2-4 months, but realistic timelines include preparation, documentation review, and potential questions from regulators.Argentina uses a 4-class (I, II, III, IV) risk-based classification system. Foreign manufacturers must appoint a Argentina Registration Holder to register devices in Argentina. Registration is valid for 5 years (renewable).

Registration Timeline by Device Class

Argentina uses a 4-class (I, II, III, IV) risk-based classification system.

Class I

Registration

Low Risk

Official

2-4 months

Realistic

4-6 months

• Minimal documentation requirements

Class II

Registration

Medium Risk

Official

4-8 months

Realistic

6-12 months

With Prior Approval

4-7 months

Accelerated with: FDA 510(k), EU CE Mark

• Technical documentation required

GMP/QMS Required

Class III

Registration with clinical data

High Risk

Official

8-12 months

Realistic

1-1.5 years

With Prior Approval

8-12 months

Accelerated with: FDA 510(k)/PMA, EU CE Mark

• Clinical evidence required

Clinical Trial RequiredGMP/QMS Required

Class IV

Full Registration

Highest Risk

Official

1-1.5 years

Realistic

1.5-2 years

With Prior Approval

1-1.3 years

Accelerated with: FDA PMA, EU CE Mark Class III

• Extensive clinical trials may be required

• On-site audit possible

Clinical Trial RequiredGMP/QMS Required

Prior Approval Recognition

Existing approvals from other regulatory authorities can accelerate your Argentina registration.

FDA 510(k)

Facilitates approval process

2-4 months

EU CE Mark

Recognized for documentation

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

Registration Validity:

5 years (renewable)

Registration Process Flowchart

Argentina Medical Device Registration Process

Step-by-step ANMAT registration process. Total estimated timeline: 4-6 months.

Step 1: Pre-Submission Preparation

1-3 months

Gather technical documentation, quality management system (QMS) records, and clinical data required by ANMAT. Appoint a Argentina Registration Holder.

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to ANMAT including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

ANMAT reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

2-4 months

In-depth technical assessment of device safety and performance. ANMAT may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, ANMAT issues Argentina market authorization certificate.

Summary: The Argentina medical device registration process through Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

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Related Resources

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Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.