一.Argentine Medical Device Regulatory Authority
AMANT (National Administration of Medicines, Food, and Medical Devices, which protects the public by ensuring the efficacy, safety, and quality of health products) is part of the Ministry of Health.
Link to the regulatory authority’s official website: https://www.argentina.gob.ar/anmat/regulados/productos-medicos
Database link: https://helena.anmat.gob.ar/Boletin/
二.Regulatory Provisions
ANMAT Disposition 64/25 (MD)
Disposition 2198/2022 (IVD)
Disposition 236/2026
Decree 892/2025
三.Risk Classification
- Classification of Medical Devices
Medical devices are classified into Class I, II, III, or IV based on the inherent risks they pose to the health of consumers, patients, operators, or relevant third parties.
- In Vitro Diagnostic Medical Devices Classification: Classes A, B, C, D
四.Requirements for Market Authorization
For imported medical devices, a registration certificate, certificate of free sale, or equivalent document issued by the competent authority of the country where the medical device is manufactured and/or marketed must be provided.
A certificate of free sale from a reference country is required. The reference countries are:
- United States
- European Union member states
- United Kingdom
- Australia
- Canada
- Japan
- Israel
- European Free Trade Association (EFTA) members (Switzerland, Norway, Iceland, Liechtenstein)
五.Requirements for the License Holder
License Holder: A legal entity, public or private entity, manufacturer, or importer holding a marketing authorization for a medical device issued by a regulatory authority.
六.Registration Language
FSC and LOA must be translated into Spanish after being notarized under the Hague Convention; all other documents may be in English.
七.Registration Timeline and Official Fees
- Official Review Period
Duration: The official review period is 180 working days.
Agent: Feedback is typically provided within 2–3 months of the official review.
- Official Fees
Official fees link: https://boletin.anmat.gob.ar/Diciembre_2022/Dispo_10114-22.pdf
