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Norm regulating import of ICU equipment is published

Norm regulating import of ICU equipment is published 

The measure is applicable to several items, such as ventilators, vital signs monitors, and infusion pumps.


Published: 05 may 2020

The measure is applicable to several items, such as ventilators, vital signs monitors, and infusion pumps.  

Last Thursday (Abril 4) Anvisa enacted Resolution RDC 378/2020, authorizing the import, sale and donation of used equipment that are essential in Intensive Care Units (ICU). The measure is already in effect and was adopted taking into account the Covid-19 pandemic. 

The authorization includes ventilators, vital signs monitors, infusion pumps, oximetry equipment (which measure the level of oxygen in the blood), and capnography equipment (which record the partial pressure of CO2 – carbon dioxide – during the respiratory cycle).  

The norm is applicable to currently registered products or to products that have had a registration by Anvisa. However, medical equipment whose registration has been canceled due to safety or efficacy problems are not included in the authorization. 

The regulation is atypical, and temporary, and will be in force until the end of the current national public health emergency situation, as defined by the Ministry of Health.   

The full document (in Portuguese) is available here. 

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