ORBIS Compliance

Brazil's ANVISA Introduces Temporary Regulation for Medical Devices During COVID-19

Published /Brazil

On March 23rd, 2020, the National Health Surveillance Agency from Brazil (ANVISA) announced Resolution - RDC No. 349/2020, which defines the extraordinary and temporary criteria and procedures to handle requests for the regularization of personal protective equipment, ventilator-type medical equipment, and other medical devices identified as strategic by ANVISA, due to the COVID-19 health emergency.

Important:

Resolution RDC 349/2020 authorizes the use of surgical masks, FFP2, and N95 respirators with a Certificate of Approval from the Ministry of Economy for use in health services, without requiring additional authorization from ANVISA throughout the validity of the Resolution (120 days from the date this resolution was announced).

For more information please contact info@orbiscompliance.com - mailto:info@orbiscompliance.com or (408) 465-7331.

Based on ANVISA website.

Brazil Quick Facts

Regulatory AgencyANATEL (Agência Nacional de Telecomunicações)
Certification TypeMandatory
License ValidityTechnical compliance certificate: 2 to 3 years
Application LanguagePortuguese
Legal License HolderRequired
In-country Testing RequirementRequires testing

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