ANVISA Announces Temporary Clinical Testing Resolution for Medical Devices Amid COVID-19

Published May 7, 2020/Brazil

Resolution Announcement

On April 17th, 2020, the National Health Surveillance Agency from Brazil (ANVISA) announced Resolution - RDC No. 375. This resolution provides an extraordinary and temporary means to submit clinical testing used for the validation of Class III and IV medical devices identified as priorities for health services during the COVID-19 health emergency, with an enforcement date of April 17th, 2020.

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 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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