Please check the MRAs with "EU-AUS" and "EU-NZ". http://europa.eu.int/comm/enterprise/international/aus_en.htm http://europa.eu.int/comm/enterprise/international/nz_en.htm As you can see the IAMD and the MDD are included but not IVD. That ist my knowledge. Mit freundlichen Grüßen Yours sincerely Dipl.-Ing. Michael Loerzer Managing Director Regulatory Affairs Specialist Chairman of the Product Conformity Group (DIN ANP German Committee of Standards Users) GLOBALNORM - Global Regulatory Compliance Fon: +49 30 6392-3860, Direct Call: 3861 Fax: +49 30 6392-3863 Rudower Chaussee 29 12489 Berlin Germany <http://www.globalnorm.ca> www.globalnorm.ca <http://www.Globalnorm.de> www.Globalnorm.de
----- Original Message ----- From: Surendra V Soman <mailto:[email protected]> To: [email protected] Sent: Tuesday, March 14, 2006 12:40 AM Subject: Registration of IVD products in Australia/New Zealand. Hello Group Members, Does anyone have any information on how to register IVD products in Australia and New Zealand? I heard is that all you need is the CE IVD mark. Is that true? All feedback is appreciated. Thanks, Suren - ---------------------------------------------------------------- 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/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] 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 [email protected] Instructions: http://listserv.ieee.org/request/user-guide.html List rules: http://www.ieee-pses.org/listrules.html For help, send mail to the list administrators: Scott Douglas [email protected] Mike Cantwell [email protected] For policy questions, send mail to: Jim Bacher: [email protected] David Heald: [email protected] All emc-pstc postings are archived and searchable on the web at: http://www.ieeecommunities.org/emc-pstc
