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. --------------------------------------------------------- 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: regr...@esaote.com --------- This message is coming from the emc-pstc discussion list. To cancel your subscription, send mail to majord...@ieee.org with the single line: "unsubscribe emc-pstc" (without the quotes). For help, send mail to ed.pr...@cubic.com, j...@gwmail.monarch.com, ri...@sdd.hp.com, or roger.volgst...@compaq.com (the list administrators).