Ensuring Regulatory Compliance for Medical Devices in Argentina
Argentina Medical Device Regulations
Argentina presents an attractive market for medical device manufacturers due to its large population, strong hospital infrastructure, and reliance on imports. The country’s regulatory framework, overseen by the National Administration of Drugs, Food, and Medical Technology (ANMAT), ensures that all medical devices meet stringent safety, quality, and performance standards before entering the market.
Understanding ANMAT’s regulatory requirements, classification system, and market access routes is crucial for manufacturers looking to expand into Argentina and the MERCOSUR region.
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Argentina's Medical Device Regulatory Framework
Regulatory Framework
Medical devices in Argentina are regulated by ANMAT, under the Ministry of Health of the Argentine Nation, established by Decree 1490/92. ANMAT is responsible for:
- Authorizing and registering medical devices
- Monitoring market compliance and safety
- Ensuring adherence to MERCOSUR regulations
- Overseeing quality control and fiscal policies
Several key regulations guide the medical device market in Argentina.
- Disposition 2318/2002 – Defines classification, labeling, registration, and GMP compliance.
- Disposition 2275/2006 – Establishes the Argentinian Declaration of Conformity based on risk category.
- Disposition 727/2013 – Mandates registration in ANMAT’s official medical device registry.
- Provision No. 2198/2022 – Classifies IVD devices per IMDRF guidelines (IMDRF/IVD WG/N64FINAL:2021).
- MERCOSUR Resolution No. 40/2000 – Promotes regulatory harmonization across Argentina, Brazil, Paraguay, Uruguay, and Bolivia.
As a MERCOSUR member, Argentina is leading efforts to harmonize regional medical device regulations. This initiative facilitates:
- Streamlined approval processes for faster market access
- Enhanced patient safety across MERCOSUR countries
- Simplified movement of medical technologies between member states
Argentina’s commitment to regional regulatory alignment supports domestic and international manufacturers looking to expand in Latin America.
Regulatory Requirements in Argentina (Quality / Clinical)
Regulatory Requirements and Local Representative
QMS requirements
- Good Manufacturing Practices (GMP) per ANMAT Disposition 3266-2013
- Argentina is an affiliate of the Medical Device Single Audit Program (MDSAP). While not a full member, ANMAT recognizes MDSAP certificates, which can potentially streamline the QMS compliance process for manufacturers already obtaining MDSAP certification.
Language requirements
- All documents and labeling must be translated into Spanish.
Local Representative
ANMAT requires foreign medical device manufacturers to appoint a local representative, known as the Argentina Authorized Representative (AAR), who must be physically based in Argentina. Unlike in other markets, this representative must be the importer, the sales representative, and the liaison with ANMAT. Furthermore, the importer must be qualified as a qualified importer.
The AAR must be ANMAT-authorized and adhere to Good Manufacturing Practices as per local regulations. Additionally, it must have a technical director and a pharmacist for handling sterile, single-use, and implantable devices. The AAR is responsible for submitting device registrations to ANMAT and is required to report any adverse events involving the devices it distributes in the Argentine market.