Argentine Medical Device Regulation

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An Overview of Medical Device Regulations in Argentina

https://www.regdesk.co/an-overview-of-medical-device-regulations-in-argentina/

Below you will find most important information on the registration process of medical devices in Argentina. Resolution 3802/2004 is one of the most crucial documents for the medical device market and has managed to unify many previous resolutions. These …

Argentina Medical Device Registration - ANMAT Approval

https://arazygroup.com/medical-device-registration-argentina/

Medical Device Regulations and Classification in Argentina. REGULATORY AUTHORITY: Medical devices are regulated by the ANMAT or Asociación Nacional de …

Healthcare Resource Guide - Argentina - International …

https://www.trade.gov/healthcare-resource-guide-argentina

Argentina’s healthcare system is comprised of 4 subsectors: Public Hospitals, the Social Security/Union-run Health Insurance System, Private Medical Insurance (Prepagas), and …

Argentina’s regulatory process for medical devices | MDRC

https://mdrc-consulting.com/argentina-regulatory-process-en/

Device classification in Argentina. Determining the proper classification for your medical device is critical to ensuring a smooth registration process. We have many years' …

LATAM Series: Argentina’s Medical Device Regulatory …

https://lifesciences.csoftintl.com/blog/latam-series-argentinas-medical-device-regulatory-pathway/

What is the Regulatory Body in Argentina? Argentina’s regulatory body is called the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica …

Argentina Medical Device Regulations | RegDesk

https://www.regdesk.co/resource-library/argentina/

Class I. Class II. Class III. Class IV. Appoint a Local Authorized Representative in Argentina that will be responsible for the registration process. AMNAT requires a Certificate of Free …

Medical Device Registration in Argentina - omcmedical.com

https://omcmedical.com/medical-device-registration-in-argentina/

Medical Device Registration in Argentina - omcmedical.com. Medical device registration in Argentina (Argentine Republic) is carried out according to general and simplified …

Medical Device Registration in Argentina - Thema Med

https://www.thema-med.com/en/medical-device-registration-argentina/

Medical Device Registration in Argentina. All Medical Devices are subject to registration. Foreign manufacturers must appoint a Local Authorized Representative …

Latin American Medical Device Regulations

https://www.mddionline.com/regulatory-quality/latin-american-medical-device-regulations

Argentina's Ministry of Health and Social Action has delegated the authority of the medical device regulations to the Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica (ANMAT). …

Argentina - Medical Technology - International Trade …

https://www.trade.gov/country-commercial-guides/argentina-medical-technology

Healthcare expenditures in Argentina traditionally account for approximately 9 to 10 percent of GDP, among the highest in the region. The Argentine medical equipment …

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