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A.N.M.A.T. - Principal - ANMAT | Argentina.gob.ar

    http://www.anmat.gov.ar/ProductosMedicos/ProductosMedicos_en.asp
    What is a medical device? ... Legislation. Regulations. Prohibition on use and/or marketing. Shutdowns and withdrawal of operating license . Back. Administrative Management Register of Meetings Accessibility Download Acrobat Reader. Avenida de Mayo 869 (C1084AAD) - …

Healthcare Resource Guide - Argentina - International …

    https://www.trade.gov/healthcare-resource-guide-argentina
    Executive Summary. Healthcare expenditures in Argentina account for approximately 9% of the GDP, among the highest in the region. Imports in the medical equipment and device …

An Overview of Medical Device Regulations in Argentina

    https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/
    Because Argentina belongs to the Latin America trade bloc, Mercosur, all imported medical devices are taxed according to the Mercosur Common External Tariff (AEC). This tariff designates the tax rate, which …

Argentina’s regulatory process for medical devices | MDRC

    https://mdrc-consulting.com/argentina-regulatory-process-en/
    Technical File preparation for submission in Argentina. Technical File provides proof that your product is safe and effective. MDRC will prepare your Technical File in accordance …

Argentina Medical Device Registration - ANMAT Approval

    https://arazygroup.com/medical-device-registration-argentina/
    REGULATORY AUTHORITY: Medical devices are regulated by the ANMAT or Asociación Nacional de Medicamentos, Alimentos y Tecnología Médica (National …

LATAM Series: Argentina’s Medical Device Regulatory …

    https://lifesciences.csoftintl.com/blog/latam-series-argentinas-medical-device-regulatory-pathway/
    For medical device companies to submit their application to register their product, they must follow ANMAT’s regulatory pathway for approval:. Argentina …

Medical Device Registration in Argentina - omcmedical.com

    https://omcmedical.com/medical-device-registration-in-argentina/
    Medical device registration in Argentina (Argentine Republic) is carried out according to general and simplified procedures. ... (The National Administration of Drugs, Foods and …

Argentina - Medical Technology - International Trade …

    https://www.trade.gov/country-commercial-guides/argentina-medical-technology
    Most imports are concentrated in equipment and devices, specialized catheters, cannulas, patient aids, orthopedic implants, and dental products. Additional …

Argentina Medical Device Regulations | RegDesk

    https://www.regdesk.co/resource-library/argentina/
    Five years. Postmarket Surveillance. Must report adverse events and device recalls. Post market studies. Language. Documents and Labeling must be in Spanish. Expected Time. …

ANMAT: the Argentinean Health Authority - Regulatory …

    https://latampharmara.com/argentina/anmat-the-argentinean-health-authority/
    Link to ANMAT website (Spanish) Apart from drug products, ANMAT is responsible for the regulation of food, medical devices, reactants for diagnose, cosmetics, dietary …



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