Medical Device Registration Process Argentina

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Argentina Medical Device Registration - ANMAT Approval

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

TIMEFRAME: The registration process takes 90-120 days for Class I devices, 180 – 365 days for Class II, III and IV devices and 180- 365 days for IVD devices. LICENSE VALIDITY: Licenses issued in Argentina expire after five years. …

Healthcare Resource Guide - Argentina - International …

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

Exporters must appoint a local medical importer (representative) company which will submit the product registration application as the Registration Holder and will be the …

An Overview of Medical Device Regulations in …

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 …

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' …

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 …

LATAM Series: Argentina’s Medical Device Regulatory …

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

Argentina Authorized Representative (AAR): ANMAT requires a local representative for the medical device company seeking authorization to be the point of …

Argentina Updates Medical Device …

https://www.regdesk.co/argentina-updates-medical-device-registration-rules/

Argentina Updates Medical Device Registration Rules. Jan 6, 2020. The National Administration of Drugs, Foods and Medical Devices (ANMAT), Argentina’s …

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 …

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

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

1) Overall requirements of the documentation concerning the products to be submitted to ANMAT along with the import authorization application: The following information …

Drug registration in Argentina - Regulatory Affairs in …

https://latampharmara.com/argentina/drug-registration-in-argentina/

In Argentina, once granted the registration, the product certificates expire in 5 years. Go to: Drug product registration renewal in Argentina Both when products are …

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