ORBIS Compliance

ANVISA Announces Temporary Regulatory Measures for Medical Devices During COVID-19

Published /Brazil

On March 23rd, 2020, the National Health Surveillance Agency of Brazil (ANVISA) announced Resolution - RDC No. 356. This resolution provides extraordinary and temporary requirements for the manufacture, import, and acquisition of prioritized medical devices in response to the COVID-19 health emergency. The enforcement period is set from April 17th, 2020, to September 19th, 2020.

Resolution Scope:

I. Surgical masks
II. Respirators
III. Goggles and face shields
IV. Disposable hospital gowns, caps, and props
V. Valves, circuits, and respiratory connections

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

Based on information from the 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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