Collegiate Board Resolution - RDC No. 830 of 06/12/2023

Name: Collegiate Board Resolution - RDC No. 830 of 06/12/2023
Creator: Brazilian Health Regulatory Agency
Keywords: classification,diagnostics,ifu,in-vitro-diagnostic-medical-devices,in-vitro-diagnostics,instructions-for-use,ivd,ivdmd,ivds,labeling,medical-devices,notification,regime,registrations,requirements,resolutions,risks

Information

Original link

Type

Resolution of the Collegiate Board

Regulated products

IVDMD, Medical Devices

Published

December 11, 2023

Last updated

December 11, 2023

Description

Provides for risk classification, notification and registration regimes, labeling requirements and instructions for use for in vitro diagnostic medical devices, including their instruments.

Organization

Brazilian Health Regulatory Agency (Anvisa) 🇧🇷

Country / Region

Brazil

License

Other (Public Domain)

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1 Main file

Resolução da Diretoria Colegiada - RDC nº 830 de 06/12/2023

Updated on December 11, 2023

pdf

URL: http://antigo.anvisa.gov.br/documents/10181/5673188/RDC_830_2023_.pdf/0dcc96d1-7bfa-4a01-9e33-69676fd1eba9
Permalink: https://data.openrid.co/en/datasets/r/b3224100-dd02-4017-ad1b-83dee1940866
MIME Type: application/pdf

Created on: December 11, 2023
Modified on: December 11, 2023

Dispõe sobre a classificação de risco, os regimes de notificação e de registro e os requisitos de rotulagem e instruções de uso de dispositivos médicos para diagnóstico in vitro, inclusive seus instrumentos.