<p>ISO/TR 12417-2:2017 provides region-specific information for</p>
<p>- local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;</p>
<p>- changes related to the drug containing part and how they are evaluated by the different local regions.</p>
<p>For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.</p>
<p>ISO/TR 12417-2:2017 is considered also as a supplement to ISO 12417‑1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.</p>
Registration number (WIID)
63851
Scope
<p>ISO/TR 12417-2:2017 provides region-specific information for</p>
<p>- local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world;</p>
<p>- changes related to the drug containing part and how they are evaluated by the different local regions.</p>
<p>For implanted products, this document is considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.</p>
<p>ISO/TR 12417-2:2017 is considered also as a supplement to ISO 12417‑1, and any relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.</p>
