Provision No. 7802/2021

Name: Provision No. 7802/2021
Creator: National Administration of Drugs, Food and Medical Devices
License: https://creativecommons.org/licenses/by/4.0/
Keywords: certificates,compliance,diagnostics,gmp,good-manufacturing-practice,import,manufacturing,practices,provisions,qualification,regulations,validity

Information

Original link

Type

Regulation

Regulated products

IVDMD, Medical Devices

Topics

Qualification Of Companies Distributing Medical Products And/ Or Diagnostic Products For In Vitro Use (Interjurisdictional Transit)., Qualification Of Medical Product Manufacturing And/Or Importing Companies

Published

January 1, 2021

Last updated

January 1, 2021

Description

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 Administration.Amend Article 6° of ANMAT Provision No. 7425/13, which shall read as follows: "It is hereby established that the term of validity of the Certificate of Compliance with Good Manufacturing Practices for Medical Products and Diagnostic Products for "in Vitro" Use shall be 5 (five) years for manufacturing and manufacturing and/or importing companies as from the date of its granting". October 19, 2021

Organization

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

Country / Region

Argentina

License

Creative Commons Attribution 4.0

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Disposición N° 7802/2021

Updated on January 1, 2021

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URL: https://www.boletinoficial.gob.ar/detalleAviso/primera/251236/20211019
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Created on: January 1, 2021
Modified on: January 1, 2021