ISO/TR 12417-2-2017 心血管移植和体外系统--血管设备药物组合产品--第2部分:地方法规信息 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 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.st edition 2017-11 Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information Implants cardiovasculaires et circuits extra-corporels — Produits de combinaison médicament-dispositif vasculaire — Partie 2: Directives règlementaires locales Reference number ISO/TR 12417-2:2017(E) ？ ISO 2017 ISO/TR 12417-2:2017(E) C