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National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Description

The National Administration of Drugs, Food, and Medical Devices, also known as Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (ANMAT), is responsible for the oversight and regulation of the healthcare, pharmaceuticals, and food and beverage industries within Argentina.

Official website

https://www.argentina.gob.ar/anmat/

Alerts and recalls of medical products - ANMAT

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Stay informed about safety alerts and recalls of medical products with ANMAT's comprehensive database.

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Provision No. 2096/2022

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

The application for Renewal of the Good Manufacturing Practices Certificate for manufacturers and/or importers of medical products and/or diagnostic products for in vitro use governed by ANMAT Provision No. 7425/13, as amended, shall be processed in accordance with the provisions of this…

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Updated on January 1, 2022

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Provision No. 2580/2022

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

The application for Renewal of the Good Manufacturing Practices Certificate for manufacturers and/or importers of medical products and/or diagnostic products for in vitro use governed by ANMAT Provision No. 7425/13 and its amendments shall be processed in accordance with the provisions of this…

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Provision No. 7802/2021

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Article 8 of ANMAT Provision No. 6052/13 is hereby amended to read as follows: "The qualification shall be granted for a term of 5 (five) years after which it shall automatically expire, and the company shall not continue performing the activities for which it was duly qualified by this National…

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Provision No. 8671/2021

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Articles 22 and 23 of ANMAT Provision No. 9688/19 are hereby replaced. B.O. December 02, 2021.

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Provision No. 562/2019

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

The manufacturing and/or import activities in national jurisdictional or for interjurisdictional trade of sunglasses shall be governed by this provision.B.O. January 18, 2019.

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Provision No. 9688/2019

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Registration, modifications, revalidation, transfer and cancellation of Class I, II, III and IV Medical Products, national and imported. B.O. December 02, 2019.

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Provision No. 2043/2019

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

This provision shall apply for the purpose of requesting, before the National Directorate of Medical Products, the authorization to Import Medical Products, including Used Medical Products and Medical Products for In Vitro Diagnostic Use. B.O. 06/03/19

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Provision No. 4930/13

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Articles 10, 11, 12 and 13 of ANMAT Provision No. 7425/13 are replaced and Articles 10 bis and 12 bis are incorporated in the same regulation (Good Manufacturing Practices for Medical Products). B.O. May 17, 2017.

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Provision 5706/2017

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

This provision shall apply to applications for registration, modification and revalidation of Class I and II medical products and applications for modification of some characteristic data of Class III and IV medical products authorized by this Administration. B.O. June 2, 2017.

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Updated on January 1, 2017

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Circular 2/2016

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Medical Products: Duties of Technical Directors.

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Circular 14/2016

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

sanitary registration of products for aesthetic use.

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CIRCULAR 8/16

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Affidavit of Annual Maintenance of Diagnostic Reagents

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Provision No. 2303/2014

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

The Medical Product Traceability System to be implemented by individuals or legal entities involved in the distribution, dispensing and application chain of medical products registered before this National Administration, under the terms set forth in Article 1 and following of the Resolution of…

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Updated on January 1, 2014

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Provision No. 2175/14

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

It is hereby established that individuals or legal entities involved in the chain of marketing, distribution and dispensing or professional application of medical products registered before the ANMAT, shall implement a traceability system to ensure the control and monitoring thereof, from the…

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Provision No. 6013/12

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

It is hereby established that medical products containing natural rubber latex in their composition must indicate it in the label. B.O. January 31st, 2012.

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Updated on January 1, 2014

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Circular N° 7/2013

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

Implementation of ANMAT Provisions No. 3265/13 and 3266/13 corresponding to Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.

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Provision N° 727/13

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

ANMAT has modified the requirements for registration of medical products in the Registry of Medical Technology Producers and Products (RPPTM) - B.O. February 6, 2013.

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Provision No. 7425/13

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

The activities of manufacture and importation of medical products and diagnostic products for "in vitro" use may only be carried out after prior authorization of the company's operation according to ANMAT Provision No. 2319/02 (T.O. 2004) and under the control of this National Administration.

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Updated on January 1, 2013

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Provision No. 6052/2013

From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷

It is hereby established that this provision shall apply to individuals or legal entities that carry out distribution and/or commercialization activities of medical products and/or products for in vitro diagnostic use of third parties outside the jurisdiction where they are authorized…

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Updated on January 1, 2013

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