Anviso Issues Temporary Resolution to Facilitate EPI Entry into Brazil

Published December 18, 2020/Brazil

Anviso published RESOLUTION - RDC No. 448, dated December 15, 2020, allowing EPI products to enter Brazilian territory without Anvisa registration. This initiative aims to aid in the fight against COVID-19 in Brazil.

It stipulates, on an extraordinary and temporary basis, the requirements for the manufacture, import, and sale of personal protective equipment identified as priorities for use in health services, in response to the emergence of international public health concerns related to SARS-CoV-2.

Brazil Quick Facts

Regulatory Agency	ANATEL (Agência Nacional de Telecomunicações)
Certification Type	Mandatory
License Validity	Technical compliance certificate: 2 to 3 years
Application Language	Portuguese
Legal License Holder	Required
In-country Testing Requirement	Requires testing

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