Argentina Product Registration Certification
Important Notes
- ANMAT Centralized Registration: All pharmaceuticals, medical devices, foods (including dietary supplements), and cosmetics require marketing authorization from the National Administration and listing on the national register.
- Dietary Supplements as "Foods for Special Purposes": Vitamins, minerals, etc., are regulated under this category with a simplified pathway compared to drugs, but with strict positive lists for ingredients, dosages, and permitted health claims.
- Local Legal Representative Requirement: A foreign manufacturer must appoint a natural or legal person domiciled in Argentina as the Legal Representative, assuming full legal responsibility for registration, quality oversight, and pharmacovigilance.
- Mandatory Spanish Language Documentation & Labeling: All technical dossiers, labels, and instructions must be in Spanish, complying with specific formats and content requirements of the Argentine Pharmacopoeia or technical regulations.
- Price Control & Reimbursement System: Drug prices are strictly controlled, and inclusion in the national reimbursement list requires negotiation. Prices for devices and supplements are mainly market-driven.
- Alignment with MERCOSUR Resolutions: As a MERCOSUR member, many of Argentina’s technical regulations align with the bloc’s harmonized resolutions, especially for medical devices and cosmetics.
Argentina Specific Requirements
- Highly Regulated & Mature Southern Cone Market: Possesses one of Latin America’s most stringent and well-established regulatory systems. ANMAT approval carries regional prestige but comes with lengthy and meticulous review processes.
- Dual Public-Private Healthcare Structure: The market is driven by both a public health system covering half the population and a developed private insurance/healthcare network, with distinct procurement, pricing, and product preferences.
- Emphasis on Scientific Evidence & Local Data: For innovative drugs and high-risk devices, ANMAT strongly recommends or even requires local clinical trial data involving Argentine populations to support registration.
- Business Risks from Economic Volatility: High inflation and exchange rate instability are persistent features, necessitating flexible pricing strategies and robust financial planning for market operations.
- Leadership Role in Regional Regulatory Harmonization: Argentina plays a key role in MERCOSUR’s technical harmonization for pharmaceuticals and devices, making its stance indicative of regional regulatory trends.
Medical Devices Registration
Regulatory Requirements
- ANMAT Registration Certification (Disposición)
- Risk-based classification system (Class I-IV)
- Quality Management System compliance (ISO 13485:2016)
- Technical documentation and labeling in Spanish language
- Appointment of Argentine Authorized Representative (Representante Técnico)
- Certificate of Free Sale from country of origin
- Clinical evaluation and performance data
- Biocompatibility testing (where applicable)
- Electrical safety certification (where applicable)
- Post-market surveillance system implementation
Main Process
- Product classification determination
- Technical documentation preparation
- ANMAT review submission
- Quality management system audit
- Registration certificate acquisition
Registration Timeline
6-18 months
Official Fees
ARS 100,000 - 500,000
Service Fees
$12,000 - $35,000
Regulatory System Overview
ANMAT
National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
Responsible for medical devices, cosmetics, food supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The core health regulatory authority in Argentina operating under national regulatory framework.
Medical Devices Registration Process
Regulatory Classification
Determine medical device risk classification (Class I-IV) and applicable registration pathway according to ANMAT guidelines
Technical Documentation Preparation
Prepare comprehensive technical documentation in Spanish including test reports, performance data, and labeling
Local Representative Appointment
Designate Argentine Authorized Representative as required by ANMAT regulations
ANMAT Application Submission
Submit medical device registration application with all supporting documentation through authorized representative
Post-Market Surveillance
Establish adverse event reporting system and Periodic Safety Update Report (PSUR) requirements
Cosmetic Products Registration
Regulatory Requirements
- Electronic Sworn Declaration (Declaración Jurada)
- Ingredient formulation safety assessment
- Spanish labeling requirements compliance
- Good Manufacturing Practices (Buenas Prácticas de Fabricación) compliance
- Manufacturer Tax Identification Number (CUIT) provision
- Product safety data and toxicological information
- Microbiological quality specifications
- Stability study documentation
- Manufacturing process description
- Quality control procedures
Main Process
- Ingredient formulation assessment
- Label review preparation
- Electronic sworn declaration submission
- GMP system establishment
- CUIT information filing
Registration Timeline
2-5 months
Official Fees
ARS 20,000 - 100,000
Service Fees
$5,000 - $15,000
Regulatory System Overview
ANMAT
National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
Responsible for medical devices, cosmetics, food supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The core health regulatory authority in Argentina operating under national regulatory framework.
Cosmetic Products Registration Process
Formula Compliance Assessment
Evaluate cosmetic ingredient safety and regulatory compliance with ANMAT requirements
Spanish Labeling Review
Prepare Spanish labeling compliant with ANMAT cosmetic regulations
Electronic Declaration Submission
Submit sworn declaration through ANMAT electronic platform (TAD)
CUIT Information Registration
Provide manufacturer Tax Identification Number to customs authorities
GMP Compliance Maintenance
Establish Good Manufacturing Practices system and prepare for ANMAT inspections
Food Supplements Registration
Regulatory Requirements
- ANMAT Registration Approval (Disposición)
- Appointment of local authorized agent
- Detailed ingredient specifications and safety evidence
- Spanish labeling compliance
- Good Manufacturing Practices certification
- Scientific evidence of safety and efficacy
- Stability study data
- Manufacturing process description
- Quality control specifications
- Product formulation details
Main Process
- Local agent appointment
- Technical documentation preparation
- ANMAT registration submission
- Scientific review assessment
- Registration certificate acquisition
Registration Timeline
4-9 months
Official Fees
ARS 50,000 - 200,000
Service Fees
$8,000 - $25,000
Regulatory System Overview
ANMAT
National Administration of Drugs, Foods and Medical Devices (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica)
Responsible for medical devices, cosmetics, food supplements, and pharmaceutical product registration approvals, quality supervision, and market surveillance. The core health regulatory authority in Argentina operating under national regulatory framework.
Food Supplements Registration Process
Local Agent Appointment
Designate legally authorized local agent or representative in Argentina
Technical Documentation Preparation
Prepare formulation, manufacturing process, quality control, and supporting documentation
Scientific Evidence Compilation
Compile scientific supporting documents for product safety and efficacy
ANMAT Registration Submission
Submit registration application and payment through local authorized agent
Ongoing Compliance Monitoring
Establish post-market safety monitoring and periodic reporting submissions