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ISO/TR 12417-2:2022

Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information

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Kehtiv alates 07.07.2022
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07.07.2022
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21.11.2017
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This document provides region-specific information for: —    local submissions and approvals for vascular device-drug combination products (VDDCPs) in countries and regions around the world; —    changes related to the drug-containing part and how they are evaluated by different local regions. 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. 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.
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