ORBIS Compliance

New Guidelines for Importing Coronavirus Diagnostic Products in Brazil

Published /Brazil

On April 2nd, 2020, the National Health Surveillance Agency from Brazil (ANVISA) announced Resolution - RDC No. 366, which provides requirements for importing products for in vitro diagnosis of Coronavirus during the public health emergency. The enforcement date is April 17th, 2020.

Basic Guide

  1. Imports of products for the in vitro diagnosis of Coronavirus can be carried out through the Import Licensing (SISCOMEX) and express shipping modalities, via companies authorized by ANVISA for importing activities.
  2. The import process must be accompanied by the following documents: a) Request for health inspection and release. b) Commercial invoice - "Invoice". c) Bill of lading. d) Product sterility test, issued by the manufacturer, when applicable. e) Declaration of the owner of the registry authorizing the import by a third party.

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

Based on 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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