ANMAT Argentina Medical Device Registration
Argentina, home to over 45 million people, presents a significant market for medical devices, with imports accounting for approximately 80% of the devices consumed. This reliance on foreign medical technology underscores the importance of understanding and navigating the local regulatory landscape for successful market entry.
Understanding Device Classifications and Regulatory Requirements in Argentina
Regulatory Authority
In Argentina, the National Administration of Drugs, Foods, and Medical Devices (ANMAT) governs the regulatory framework for medical devices. The classification of medical devices into four risk categories from Class I (low risk) to Class IV (high risk) mirrors the EU classification system, facilitating a structured approach to regulatory compliance.
Classification
The classification system in Argentina segments medical devices based on risk, aligning with the European Union's standards. This categorization plays a crucial role in defining the regulatory requirements for each device.
Key Requirements
To market medical devices in Argentina, foreign manufacturers must navigate:
- Classification and grouping of products to identify the regulatory pathway.
- Appointment of a local registration holder authorized by ANMAT, essential for importing and clearing shipments through customs.
- The registration process with ANMAT, facilitated by a local company for manufacturers without a local presence.
Tailored Support for Market Entry
Our expertise in Argentina's medical device market offers you:
Assistance in classifying and grouping your products for regulatory compliance.
Compilation of technical submission for the registration process with ANMAT.
Representation as your Holder for registration submissions to ANMAT, managing the importation process, and ensuring post-market regulatory compliance.
Support focusing on your commercial success while we handle regulatory intricacies.
We Provide Access To 28+ Markets Worldwide
Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.
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Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.