Incident reporting by companies

Name: Incident reporting by companies
Creator: Spanish Agency for Medicines and Medical Devices
Keywords: forms,guidelines,incidents,medical-devices,notification,reporting,updates,vigilance

Information

Original link

Type

Miscellaneous

Regulated products

Medical Devices

Topics

Medical Device Vigilance

Published

August 22, 2019

Last updated

June 10, 2024

Description

Last update: November 23, 2021 Included are the notification forms for the Guidelines on the Medical Device Vigilance System that can be completed and submitted by email to psvigilancia@aemps.es or by fax to +34918225289 Notification Form. Incident Report of the...

Organization

Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸

Country / Region

Spain

License

Other (Public Domain)

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3 Main files

Formulario de Notificación. Informe de Incidente del Fabricante

Updated on November 16, 2023

pdf

URL: https://www.aemps.gob.es/vigilancia/productosSanitarios/docs/MIR_form_v7.2.pdf
Permalink: https://data.openrid.co/en/datasets/r/6457b9a8-e6d8-4d18-b6d2-9c4d09e0d0ba
MIME Type: application/pdf

Created on: November 16, 2023
Modified on: November 16, 2023

Formulario de Notificación. Acción Correctiva de Seguridad en Campo

Updated on November 16, 2023

pdf

URL: https://www.aemps.gob.es/vigilancia/productosSanitarios/docs/2_12_1-fsca_en.pdf
Permalink: https://data.openrid.co/en/datasets/r/bcba8aa8-d241-447e-9062-d7d00a545756
MIME Type: application/pdf

Created on: November 16, 2023
Modified on: November 16, 2023

Notificación de incidentes por parte de las empresas

Updated on June 10, 2024

html

URL: https://www.aemps.gob.es/productos-sanitarios/vigilancia_productossanitarios/vigilancia-empresas/
Permalink: https://data.openrid.co/en/datasets/r/154f5e6e-d66e-4fba-bad6-a3719a9ec588
MIME Type: text/html

Created on: August 22, 2019
Modified on: June 10, 2024