REGULATORY UPDATES IMDRF Stakeholders Meeting Vancouver, Canada - - PowerPoint PPT Presentation

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Mar 15, 2023 480 likes •553 views

REGULATORY UPDATES IMDRF Stakeholders Meeting Vancouver, Canada March, 2017 ANVI SA Brazil Norm ative I nstruction, ANVI SA n 1 3 - Novem ber 8 th , 2 0 1 6 This document establishes specific criteria for medical devices grouping

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REGULATORY UPDATES IMDRF Stakeholders Meeting Vancouver, Canada March, 2017

ANVI SA Brazil

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Norm ative I nstruction, ANVI SA nº

1 3 - Novem ber 8 th, 2 0 1 6

 This document establishes specific criteria for medical devices grouping in the regulatory review process at ANVISA.

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Public

Consultation, ANVI SA nº 2 5 7 - Septem ber 2 8 th, 2 0 1 6

 This draft technical regulation establishes requirements for the registration of medical devices which re-use is prohibited, its labeling, instructions for use and gives other provisions.

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Public Consultation, ANVI SA nº 2 82
Decem ber 9 th, 2 0 1 6

 This draft technical regulation establishes Good Clinical Practices (GCP) inspection procedures for clinical trials of medical devices.

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ANVI SA

recognition

MDSAP Auditing Organizations

Auditing Organization Resolution Laboratoire National de Métrologie et d'Essais (GMED Certification Division) Resolution RE n. 31, published on January 1st, 2017 BSI Group America Inc. Resolution RE n. 23, published on January 5th, 2017 DQS Medizinprodukte GmbH Resolution RE n. 194, published on January 24th, 2017 DEKRA Certification B.V. Resolution RE n. 193, published on January 24th, 2017 TUV SUD America Inc. Resolution RE n. 324, published on February 8th, 2017 Intertek Testing Services NA Inc. Resolution RE n. 323, published on February 8th, 2017

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