ISO/TR 12417-2:2022
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 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.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information on device- and drug-related aspects — Applicable documents for local guidance
4.1 General
4.2 Australia
4.2.1 General
4.2.2 Australia: Managing changes
4.2.3 Australia: Clinical evaluation requirements
4.2.4 Australia: Audit requirements
4.3 Brazil
4.3.1 Brazil: Managing changes
4.3.2 Brazil: Clinical evaluation requirements
4.3.3 Brazil: Audit requirements
4.4 Canada
4.4.1 Canada: Managing changes
4.4.2 Canada: Clinical evaluation requirements
4.4.3 Canada: Audit requirements
4.5 European Union (EU)
4.5.1 EU: Managing changes
4.5.2 EU: Material inclusion and labelling requirements
4.5.3 EU: Clinical evaluation requirements
4.5.4 EU: Audit requirements
4.6 India
4.6.1 India: Managing changes
4.6.2 India: Clinical evaluation requirements
4.6.3 India: Audit requirements
4.7 Japan
4.7.1 Japan: Managing changes
4.7.2 Japan: Clinical evaluation requirements
4.7.3 Japan: Audit requirements
4.8 People's Republic of China (PRC)
4.8.1 PRC: Managing changes
4.8.2 PRC: Clinical evaluation requirements
4.8.3 PRC: Audit requirements
4.9 Russia
4.9.1 Russia: Managing changes
4.9.2 Russia: Clinical evaluation requirements
4.9.3 Russia: Audit requirements
4.10 United States of America (USA)
4.10.1 USA: Managing changes
4.10.2 USA: Clinical evaluation requirements
4.10.3 USA: Audit requirements
5 Managing changes that can impact the DCP
5.1 General
5.2 Change evaluation
5.2.1 Identify changes
5.2.2 Risk evaluation
5.2.3 Guidance for change evaluation
5.2.4 Pre-market
5.3 Interactions with region-specific regulatory authorities — Post-commercialization
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Information on device- and drug-related aspects — Applicable documents for local guidance
4.1 General
4.2 Australia
4.2.1 General
4.2.2 Australia: Managing changes
4.2.3 Australia: Clinical evaluation requirements
4.2.4 Australia: Audit requirements
4.3 Brazil
4.3.1 Brazil: Managing changes
4.3.2 Brazil: Clinical evaluation requirements
4.3.3 Brazil: Audit requirements
4.4 Canada
4.4.1 Canada: Managing changes
4.4.2 Canada: Clinical evaluation requirements
4.4.3 Canada: Audit requirements
4.5 European Union (EU)
4.5.1 EU: Managing changes
4.5.2 EU: Material inclusion and labelling requirements
4.5.3 EU: Clinical evaluation requirements
4.5.4 EU: Audit requirements
4.6 India
4.6.1 India: Managing changes
4.6.2 India: Clinical evaluation requirements
4.6.3 India: Audit requirements
4.7 Japan
4.7.1 Japan: Managing changes
4.7.2 Japan: Clinical evaluation requirements
4.7.3 Japan: Audit requirements
4.8 People's Republic of China (PRC)
4.8.1 PRC: Managing changes
4.8.2 PRC: Clinical evaluation requirements
4.8.3 PRC: Audit requirements
4.9 Russia
4.9.1 Russia: Managing changes
4.9.2 Russia: Clinical evaluation requirements
4.9.3 Russia: Audit requirements
4.10 United States of America (USA)
4.10.1 USA: Managing changes
4.10.2 USA: Clinical evaluation requirements
4.10.3 USA: Audit requirements
5 Managing changes that can impact the DCP
5.1 General
5.2 Change evaluation
5.2.1 Identify changes
5.2.2 Risk evaluation
5.2.3 Guidance for change evaluation
5.2.4 Pre-market
5.3 Interactions with region-specific regulatory authorities — Post-commercialization
Bibliography