ANVISA modifies the criteria for manufacture, import and purchase of medical devices

Published on 23 March, 2020, RDC nº 356/2020 simplifies the procedures to produce and import health equipment necessary to fight the pandemic, such as personal protection equipment and medical equipment. From now on, companies performing this sort of economic activity are exempted from prior operation authorizations (AFE), from prior notification to ANVISA and from presenting a sanitary license. This added flexibility to produce and import the products of interest allows companies to effectively respond to the society’s needs during the crisis.

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