Paulo, 1. Your approval to ISO 13485 must be by a Notified Body or other registrar which is accredited by the Canadian Medical Devices Conformity Assessment System (CMDCAS)
2. The Canadian Medical Device Regulations are available at: http://laws.justice.gc.ca/en/f-27/sor-98-282/text.html 3. Guidance on how to apply for a medical device licence is available at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/lcn_nw4_e.html 4. The frequently asked questions at: http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/quesans9_e.html may also be useful. I hope this helps. Regards, Jon Griver http://www.601help.com The Medical Device Designers' Guide to IEC 60601-1 Subject: canadian requirements for medical devices From: "P. Peruzzi" <standa...@elen.it> List-Post: emc-pstc@listserv.ieee.org Date: Tue, September 14, 2004 3:42 am To: emc-p...@ieee.org 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 emc-p...@ieee.org 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: emc-p...@hypercom.com Dave Heald: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc 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 emc-p...@ieee.org 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: emc-p...@hypercom.com Dave Heald: emc_p...@symbol.com For policy questions, send mail to: Richard Nute: ri...@ieee.org Jim Bacher: j.bac...@ieee.org All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
