<p>ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. </p>
<p>Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use. </p>
<p>Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.</p>
<p>Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. </p>
<p>IVD medical devices for self-testing are excluded. </p>
Registration number (WIID)
38590
Scope
<p>ISO/TR 18112:2006 summarizes regulatory requirements and associated guidance for information supplied by the manufacturer with IVD medical devices intended for professional use. </p>
<p>Information supplied by the manufacturer includes labels on the outer and immediate container as well as instructions for use. </p>
<p>Current labelling regulations and regulatory guidance from Canada, the European Union, Japan and the United States are included.</p>
<p>Labelling guidance from the Global Harmonization Task Force and proposed labelling regulations from Australia are included for comparison. </p>
<p>IVD medical devices for self-testing are excluded. </p>
