Declaring/recording activities of operators, medical devices, assemblies (systems/accessories), and person in charge of MD vigilance

Name: Declaring/recording activities of operators, medical devices, assemblies (systems/accessories), and person in charge of MD vigilance
Creator: National Agency for the Safety of Medicines and Health Products
Keywords: guidances,medical-devices,vigilance

Information

Original link

Type

Guidance

Regulated products

Medical Devices

Last updated

July 29, 2024

Description

Approach Declaring/recording activities of operators, medical devices, assemblies (systems/accessories), and the person in charge of MD vigilance

Organization

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

Country / Region

France

License

Other (Non-Commercial)

Feedback

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3 Main files

Formulaire de déclaration d’activité des opérateurs relative aux dispositifs médicaux, du correspondant de matériovigilance, et de déclaration de mise sur le marché des dispositifs médicaux par les fabricants (08/08/2023)

Updated on August 8, 2023

docx

URL: https://ansm.sante.fr/uploads/2023/08/08/20230808-formulaire-declaration-activites-dm.docx
Permalink: https://data.openrid.co/en/datasets/r/14d12d19-d488-432d-9a2b-e2966f7d9f8b
MIME Type: application/vnd.openxmlformats-officedocument.wordprocessingml.document

Created on: August 8, 2023
Modified on: August 8, 2023

Notice explicative : Modalités de déclarations des dispositifs médicaux, des opérateurs et du correspondant de matériovigilance (08/08/2023)

Updated on August 8, 2023

pdf

URL: https://ansm.sante.fr/uploads/2023/08/08/20230808-notice-explicative-dm.pdf
Permalink: https://data.openrid.co/en/datasets/r/3c907943-a5c4-49f0-8cd2-67c40ea3b1c7
MIME Type: application/pdf

Created on: August 8, 2023
Modified on: August 8, 2023

Déclarer / enregistrer des activités des opérateurs, des dispositifs médicaux, des assemblages (systèmes/nécessaires), et le correspondant de matériovigilance

Updated on July 29, 2024

html

URL: https://ansm.sante.fr/vos-demarches/industriel/declarer-enregistrer-des-activites-des-operateurs-des-dispositifs-medicaux-des-assemblages-systemes-necessaires-et-le-correspondant-de-materiovigilance
Permalink: https://data.openrid.co/en/datasets/r/435ce3ff-f589-4ec6-903d-35649856897d
MIME Type: text/html

Created on: July 5, 2024
Modified on: July 29, 2024