In vitro diagnostic medical devices - Requesting authorization for a performance study

Name: In vitro diagnostic medical devices - Requesting authorization for a performance study
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: authorization,diagnostics,guidances,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,ivd,ivdmd,ivds,medical-devices,performance,procedures,requests

Information

Original link

Type

Guidance

Regulated products

IVDMD, Medical Devices

Last updated

August 7, 2024

Description

Procedure In vitro diagnostic medical devices - Requesting authorization for a performance study

Organization

National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷

Country / Region

France

License

Other (Non-Commercial)

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23 Main files

Avis aux promoteurs pour une recherche impliquant la personne humaine (RIPH) pour les dispositifs médicaux de diagnostic in vitro (08/07/2022)

Updated on July 8, 2022

pdf

URL: https://ansm.sante.fr/uploads/2022/07/08/20220705-ec-dmdiv-aec-doc033-v01-aap-riph-dmdiv.pdf
Permalink: https://data.openrid.co/en/datasets/r/ad81f8ea-1002-485a-9071-c05b2fedc2ef
MIME Type: application/pdf

Created on: July 8, 2022
Modified on: July 8, 2022

Courrier de demande d’autorisation d’essai clinique (AEC) portant sur un dispositif médical de diagnostic in vitro (08/07/2022)

Updated on July 8, 2022

docx

URL: https://ansm.sante.fr/uploads/2022/07/08/1-courrier-aec-div.docx
Permalink: https://data.openrid.co/en/datasets/r/a2a65173-2d67-47cf-bc0f-80efa3fcc51a
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: July 8, 2022
Modified on: July 8, 2022

Formulaire de demande d’autorisation auprès de l'ANSM et demande d’avis du comite de protection des personnes (CPP) pour une recherche mentionnée au 1° ou au 2° de l’article L. 1121-1 du code de la santé publique (RIPH1 ou 2) portant sur un dispositif médical de diagnostic in vitro (08/07/2022)

Updated on July 8, 2022

docx

URL: https://ansm.sante.fr/uploads/2022/07/08/2-faec-div.docx
Permalink: https://data.openrid.co/en/datasets/r/2fc5e87a-afce-424d-bb0e-b270b15494c2
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: July 8, 2022
Modified on: July 8, 2022

Courrier de demande d’autorisation de modification substantielle d’essai clinique portant sur un dispositif médical de diagnostic in vitro (08/07/2022)

Updated on July 8, 2022

docx

URL: https://ansm.sante.fr/uploads/2022/07/08/3-courrier-msa-dmdiv.docx
Permalink: https://data.openrid.co/en/datasets/r/2d74f601-f037-43c3-9c7b-b70e71c03521
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: July 8, 2022
Modified on: July 8, 2022

Formulaire de demande de modification substantielle d’une recherche mentionnée au 1° ou au 2° de l’article L. 1121-1 du code de la santé publique portant sur un dispositif médical de diagnostic in vitro (08/07/2022)

Updated on July 8, 2022

docx

URL: https://ansm.sante.fr/uploads/2022/07/08/4-form-msa-dmdiv.docx
Permalink: https://data.openrid.co/en/datasets/r/146f6f8e-7b81-4b55-94ab-62979e64d4d9
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: July 8, 2022
Modified on: July 8, 2022

Attestation en vue d'une importation de médicaments nécessaires à la réalisation d'un essai clinique autorisé en France (08/07/2022)

Updated on July 8, 2022

docx

URL: https://ansm.sante.fr/uploads/2022/07/08/5-attestation-autorisation-importation-ec.docx
Permalink: https://data.openrid.co/en/datasets/r/58082bab-f70f-4e17-b228-1dd9abb373b3
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: July 8, 2022
Modified on: July 8, 2022

See the 23 main files

In vitro diagnostic medical devices - Requesting authorization for a performance study

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