1. Certification Overview
ANMAT conducts product certifications for pharmaceuticals, food, cosmetics, and household chemical products, as well as products and medical technologies in general. Products in the medical field include medical equipment, machinery, various medical and dental supplies, diagnostic materials and reagents, quasi-drugs, and biomedical substances; market launch is only possible after obtaining a registration number through ANMAT’s official authorization (certification) process.
Argentina classifies medical devices into four classes, from Class I to IV, based on the inherent risk to the health of users, patients, operators, or related third parties.
Class I&II: Subject to reporting and declaration of conformity that relax document requirements or proceed in the form of a declaration
Class III&IV: Subject to formal registration requiring rigorous comprehensive technical documentation evaluation and authorization by ANMAT technical examiners
2. Regulatory Agencies & Basic Information
| Regulatory Agencies | ANMAT (Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) |
| Testing Agency | ANMAT Authorized Laboratories (INTI, IRAM, CNEA) |
| Lead time / Price | Varies by product |
| Language | Spanish |
| Agent | Local agent required |
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class I | Low risk | • Manual Surgical & Examination Instruments: Surgical forceps, Tongue depressors, Mechanical stethoscopes • General Medical Furniture & Mobility Aids: Manual hospital beds, Wheelchairs, Crutches • Non-sterile Surgical Consumables: Adhesive bandages, Non-sterile gauze |  Adhesive bandage |
| Class II | Moderate risk | • Electronic Monitoring & Care Devices: Electronic blood pressure monitors, Digital thermometers, Hearing aids • Sterile Surgical Consumables: Sterile syringes & needles, Infusion sets • Energy-based Home Beauty Devices: High-frequency/RF skin care tools, LED light therapy masks, EMS microcurrent devices |  EMS microcurrent devices |
| Class III | High risk | • Active Diagnostic & Imaging Systems: Diagnostic X-ray apparatus, Ultrasound imaging systems, Magnetic Resonance Imaging/MRI • Professional Aesthetic & Surgical Equipment: High-intensity focused ultrasound/HIFU for clinical use, High-frequency surgical units, Surgical laser systems • Absorbable Surgical Materials & Injections: Hyaluronic acid dermal fillers, Absorbable surgical sutures, Contact lenses |  Surgical laser systems |
| Class IV | Maximum risk | • Life-Sustaining & Implantable Cardiac Devices: Implantable pacemakers, Coronary/Vascular stents, Artificial heart valves • Advanced Life-Support Equipment: Mechanical ventilators, Defibrillators, Anesthesia machines • Permanent Orthopedic Implants: Artificial hip joints, Bone screws & fixation plates |  Artificial hip joints |
4. Certification Process
- Selection of Local Legal Representative (AAR) and Import Permit
- Product classification and technical documentation (Dossier) compilation
- Recognition of GMP (Good Manufacturing Practice) compliance of overseas manufacturing facilities
- HELENA Portal Document Filing and Review Track Branch
- Track A: Class I & II [Declaration and Declaration of Conformity]
- Track B: Class III & IV [Formal Technical Review Track]
- ANVISA Registration Issuance and Post-registration Management
5. Required Documents
| Administrative & Legal Documents | • Letter of Appointment / Power of Attorney (POA) • ANMAT Registration Application Form • Receipt for Payment of Registration Fee • Free Sale Certificate (FSC) |
| Quality Management System Documents | • Quality Management System Certification (QMS / ISO 13485 Certification) • Documentation proving exemption from on-site GMP inspection (GMP Bypass Documentation) |
| Technical & Safety Dossier | • Technical Specifications & Manufacturing Process • Essential Principles Matrix • Risk Management Report • Spanish Labeling & Instructions for Use (IFU) • [Class III, IV Only] Test Reports & Clinical Evidence |
6. Validity Period & Maintenance
- Certification Validity Period: 5 years
- Renewal: Renewal application required 6 to 9 months before expiration
- Maintain the qualification of the Technical Chief Pharmacist of the Local Representative (AAR) at all times.
Source
ANMAR Homepage