Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products - Local regulatory information

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products - Local regulatory information

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1   Scope

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.