ISO - TR 12417-2
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
Organization: | ISO |
Publication Date: | 1 July 2022 |
Status: | active |
Page Count: | 36 |
ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
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.