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ISO - TR 12417-2

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

active, Most Current
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.

Document History

TR 12417-2
July 1, 2022
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
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...
November 1, 2017
Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products - Part 2: Local regulatory information
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...

References

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