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Medical devices — Agência Nacional de Vigilância …

    https://www.gov.br/anvisa/pt-br/english/regulation-of-products/medical-devices
    Anvisa categorizes Medical Devices into four types: medical equipments, materials for health use, orthopedic implants and in vitro diagnostics. Market authorizations Market authorizations are issued by Anvisa depending on the risk classification of the medical device. See more

ANVISA Resolutions: Medical Device Single Audit …

    https://www.fda.gov/medical-devices/medical-device-single-audit-program-mdsap/anvisa-resolutions-medical-device-single-audit-program-mdsap
    ANVISA Resolutions: Medical Device Single Audit Program (MDSAP) | FDA An …

Brazil’s Anvisa Updates Medical Device Regulations with RDC …

    https://globalregulatorypartners.com/brazils-anvisa-updates-medical-device-regulations-with-rdc-751-2022/
    The Brazilian Health Regulatory Agency (ANVISA) issued the new medical device regulation RDC No. 751/2022 on Sept. 21, 2022. Introduction: The new RDC …

New guidelines for the regulation of medical devices in Brazil will ...

    https://www.clarkemodet.com/en/news-posts/new-guidelines-for-the-regulation-of-medical-devices-in-brazil-will-become-effective-in-2023/
    The RBD no. 751/2022 also determines that medical devices must be classified according to the risks to human health that they may present, following the …

Brazil’s medical device regulator updates …

    https://www.emergobyul.com/news/brazil-anvisa-announces-major-medical-device-registration-updates
    Brazil ANVISA Announces Major Medical Device Registration Updates. September 16, 2022. Brazil’s medical device market regulator, ANVISA …

Brazil ANVISA Regulatory Approval …

    https://www.emergobyul.com/resources/brazil-anvisa-regulatory-approval-process-medical-devices
    Medical device manufacturers need to obtain ANVISA (Agência Nacional de Vigilância Sanitária) approval prior to selling their products in Brazil. Brazil has four …

Anvisa’s new rules on the regulation of …

    https://lifesciences.dlapiper.com/post/102hyao/anvisas-new-rules-on-the-regulation-of-medical-devices-brazil
    Anvisa’s new rules on the regulation of medical devices - Brazil. As previously shared when the new regulatory framework for software as a medical device …

Home - Anvisa

    http://antigo.anvisa.gov.br/en/english
    The Brazilian Health Regulatory Agency (Anvisa) is an autarchy linked to the Ministry of Health, part of the Brazilian National Health System (SUS) as the coordinator of the …

Brazil’s New Rules for Class II Medical …

    https://www.regdesk.co/brazil-anvisa-class-ii-medical-devices/
    The National Health Surveillance Agency (ANVISA) of Brazil has announced changes in the regulations on Class II medical devices. The devices are …

BRAZIL: ANVISA, kicks off to UDI system for Medical Devices

    https://www.thema-med.com/en/2021/09/21/brazil-anvisa-kicks-off-to-udi-system-for-medical-devices/
    In this document, ANVISA suggests different deadlines to allow Medical Devices Manufacturers to conform to UDI requirements, fundamental to boost Medical …



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