ISO TR 12417-2
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information
|Publication Date:||1 November 2017|
|ICS Code (Implants for surgery, prosthetics and orthotics):||11.040.40|
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 the 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. Requirements listed in this document also address VDDCPs that are not necessarily permanent implants.