Medical Device Regulatory Requirements Argentina

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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. …

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' …

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 …

LATAM Series: Argentina’s Medical Device Regulatory …

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

For medical device companies looking to expand into Argentina’s diverse market, there are several important factors to take into consideration: Mercosur Common …

Argentina Medical Device Regulations | RegDesk

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

Appoint a Local Authorized Representative in Argentina that will be responsible for the registration process. AMNAT requires a Certificate of Free Sale …

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 …

Latin American countries' regulatory …

https://mdrc-consulting.com/south-america-regulatory-processes-en/

Regulatory requirements of the biggest Latin American markets are largely harmonized under the South American trade bloc Mercosur comprising Argentina, Brazil, …

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 …

ANMAT: the Argentinean Health Authority | Regulatory Affairs in …

https://latampharmara.com/argentina/anmat-the-argentinean-health-authority/

The recognition follows an evaluation of the agency’s performance of basic functions, recommended by WHO, for ensuring the quality, safety and efficacy of medicines in the …

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

http://www.anmat.gov.ar/webanmat/DispRec/donacionesgral-productos_medicos_en.asp

A medical device is a product intended for health such as a piece of equipment, an apparatus, a material, an article or system for medical, dental or laboratory use, for …

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