ISO TR 12417-2

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

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Organization: ISO
Publication Date: 1 November 2017
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 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.

Document History

ISO TR 12417-2
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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