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<p>This document 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 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>This document 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. This document also addresses VDDCPs that are not necessarily permanent implants.</p>
Reģistrācijas numurs (WIID)
80895
Darbības sfēra
<p>This document 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 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>This document 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. This document also addresses VDDCPs that are not necessarily permanent implants.</p>
