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If the company is OBL (orginal brand label) and does not have own iso 13485 certificate can register products in Australia (and be “legal manufacturer)? I should mention that OEM (orginal equipment manufacury) owns iso 13485 certificate so these products are comply with the iso 13485. ??????????????????? source: https://www.linkedin.com/groups/2070960/2070960-6108416755271561216 Marked as spam
 Posted by Asked on February 25, 2016 8:00 am
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Good question for Arthur Brandwood or @Sarah Griffin or @Suzanne Williams
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Arthur Brandwood
Quick reply late at night Down Under.... The issue is not the 13485, it's the CE certificate. If you have CE cert for the device then in most cases you can present that to TGA to obtain a registration. No CE cert neans you have to have a direct TGA conformity assessment.
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