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Medical Device Registration Process in Brazil - Anvisa (Part 2)

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Marcelo Antunes

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If I am not wrong from 01/01/2014 IEC60601-1:2005 (3rd Ed.) is mandatory in Brazil. Our device manufactured in Brazil has a INMETRO Certificate for ABNT NBR IEC 60601-1:1997 valid till 22/01/2015. Does this mean that till that date (22/01/2015) a conformity to IEC60601-1:2005 (3rd Ed.) is not required?
In principle yes. There will be some news on the date and compliance in the near future as INMETRO will finally publish a draft of the revision of Portaria 350 and ANVISA will also publish a new normative instruction.
 
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