Hi group, I'm not familiar with canadian regulation and I've collected not very clear answers on the matter; I'd like to know what exactly I have to do in order to sell a medical device in Canada. What I've understood is that my company should have a quality system in compliance with Canadian version of 13485 (and it already has), and we shall apply the "medical devices canadian directive " .... If it's correct, where can I find such a directive? And what about technical standards? I know only 601-1 deviations. Is there a sort of "harmonized standards list" like fo EU MDD?
thanks in advance, Paolo Peruzzi El.En. S.p.A. Via Baldanzese, 17 50041 Calenzano (FI) Italy Tel. +39 055 8826807 FAX +39 055 8832884 http://www.elengroup.com/ This message is from the IEEE Product Safety Engineering Society emc-pstc discussion list. Website: http://www.ieee-pses.org/ To post a message to the list, send your e-mail to [email protected] Instructions: http://listserv.ieee.org/listserv/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Ron Pickard: [email protected] Dave Heald: [email protected] For policy questions, send mail to: Richard Nute: [email protected] Jim Bacher: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
