Regulatory strategy
Initial assessment, device classification and development of the full approval roadmap in the country.
ANMAT
Register your medical device in Argentina.
Register under Disposicion ANMAT 2318/2002 (MERCOSUR/GMC/RES No. 40/00), with the simplified procedure under Disposicion 236/2026.
Speak to a specialistThe authority
Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
ANMAT
Regulatory authority
Argentina
A decentralised body of the Ministry of Health responsible for the sanitary regulation of medicines, food and medical technology in Argentina.
Visit the official websiteRegulatory framework
Main legislation and risk classes
| Class | Description | Examples |
|---|---|---|
| Class I | Low risk | Bandages, masks, gauze |
| Class II | Low-to-moderate risk | Simple diagnostic equipment |
| Class III | Moderate-to-high risk | Infusion pumps, surgical equipment |
| Class IV | High risk | Implants, pacemakers, haemodialysis equipment |
Registration process
How we manage your project
- 01
Registration Holder (Titular del Registro)2-3 months
Establish an Argentine company as the Registration Holder
- 02
MERCOSUR classification2 weeks
Apply MERCOSUR classification (Resolucion GMC No. 25/21)
- 03
QMS3-6 months
ISO 13485 or Latin American GMP
- 04
Technical dossier2-4 months
Prepare the application in Spanish (or a Declaracion Jurada under Disposicion 236/2026)
- 05
ANMAT submission6-12 months
ANMAT technical assessment
- 06
Certificate issuance1-2 weeks
Health Registration number issued
Total timeframeTraditional pathway: 9-15 months. Disposicion 236/2026 pathway (Declaracion Jurada): faster for eligible products
Local representativeRegistration Holder (Argentine company)
Approximate costOn request
Post-market
Post-approval obligations
| Area | Requirement |
|---|---|
| Surveillance | ANMAT technovigilance and periodic reporting |
| Renewal | 5 years, renewable |
| Required QMS | ISO 13485 or Latin American GMP |
How HSC helps
Argentina through MERCOSUR or an accelerated Declaracion Jurada.
Technical dossier
Document preparation and translation in accordance with local requirements, including responses to deficiencies and requests.
Local representation
Acting directly as legal representative or recommending an authorised partner accredited by the authority.
Ongoing post-market support
Monitoring regulatory changes, renewals, surveillance and responses to authority audits.
Frequently asked questions
Questions about ANMAT
Next step
Ready to start your project in Argentina?
Speak to our team for an initial assessment of your product and the most efficient regulatory pathway.
Speak to a specialist