Brazil medical device QA/RA blog

News and commentary on regulatory changes.

ANVISA Strike to Delay Medical Device Reviews in Brazil

Employees of Brazil’s medical device regulator ANVISA have gone on strike for an indeterminate length of time, resulting in delays for device manufacturers awaiting regulatory approval to sell their products in the country.

According to Emergo Group’s office in Brazil, ANVISA is now providing only essential services; the agency is required by Brazilian law to maintain a workforce adequate enough to keep 30% of its operations up and running. Further information in Portuguese is available on the ANVISA website.

Emergo Group will provide additional news and details as soon as they are received and verified. It is clear, however, that operating at only 30% of its capacity will significantly impact ANVISA review and approve medical device submissions for at least the near future.




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