I am not all that familiar with the New Zealand requirements but I believe there is a Trans-Tasman Regulation System soon to be implemented designed to harmonise the requirements of medical devices in both Australia and New Zealand. In Australia, medical devices and IVD devices are regulated under the Therapeutic Goods Act (the legislation), administered by the Therapeutic Goods Administration (TGA). TGA URL is www.tga.gov.au You may wish to have a look at The Medical Industry Association of Australia (MIAA) sight as well - www.miaa.org.au made a "Submission to the Australian Government Regulation Task Force"
Best regards, Kevin Richardson Stanimore Pty Limited Compliance Advice & Solutions for Technology (Legislation/Regulations/Standards/Australian Agent Services) Ph: 02-4329-4070 (Int'l: +61-2-4329-4070) Fax: 02-4328-5639 (Int'l: +61-2-4328-5639) Mobile: 04-1224-1620 (Int'l: +61-4-1224-1620) Email: [email protected] URL: www.stanimore.com This material (this message and the information contained in all attachments to this message) is confidential and/or privileged information and is intended only for the addressee/s named above. Any unauthorised dissemination, copying, use of or reliance upon this material by persons or entities other than the addressee/s named above is prohibited. If you receive this material in error, please notify Stanimore Pty Limited and destroy all copies (electronic and hardcopy) of this message and all attachments immediately. From: [email protected] [mailto:[email protected]]On Behalf Of Surendra V Soman Sent: Tuesday, 14 March 2006 10:41 AM To: [email protected] 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
