Brazil - ANVISA - distance selling

P

pankracy007

Registered
Hi All,

Quick question for Brazilian / ANVISA regulations for IVDs experts: Are there any 'distance selling' rules in place?

Background into the request:
We manufacture an IVD kit that has been approved by ANVISA for use on the market. Our distributor is asking if they could send samples out of Brazil for them to be run in a lab abroad on that kit that has been approved in Brazil & then subsequently for the results to be reported in Brazil?

Many thanks for you help and support!
Regards,
pankracy
 
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