Does anybody out of there know which are the steps to be taken in order to
get the approval for a medical device to be sold in Brazil?
Do they recognize international standards as IEC 60601-1 and family?
What is the relevant law?
Which are the Notified Bodies for medical devices?
Thanks for any help.
m.p.
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ESAOTE S.p.A. Massimo Polignano
Research & Product Development Design Quality Control
Via di Caciolle,15 tel:+39.055.4229402
I- 50127 Florence fax:+39.055.4223305
e-mail: [email protected]
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