ISO/TR 12417-2:2017
Cardiovascular implants and extracorporeal systems — Vascular device-drug combination products — Part 2: Local regulatory information
ISO/TR 12417-2:2017 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.
ISO/TR 12417-2:2017 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.
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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 Australia
4.1.1 Australia: managing changes
4.1.2 Australia: clinical evaluation requirements
4.1.3 Australia: audit requirements
4.2 Brazil
4.2.1 Brazil: managing changes
4.2.2 Brazil: clinical evaluation requirements
4.2.3 Brazil: audit requirements
4.3 Canada
4.3.1 Canada: managing changes
4.3.2 Canada: clinical evaluation requirements
4.3.3 Canada: audit requirements
4.4 European Union (EU)
4.4.1 EU: managing changes
4.4.2 EU: clinical evaluation requirements
4.4.3 EU: audit requirements
4.5 India
4.5.1 India: managing changes
4.5.2 India: clinical evaluation requirements
4.5.3 India: audit requirements
4.6 Japan
4.6.1 Japan: managing changes
4.6.2 Japan: clinical evaluation requirements
4.6.3 Japan: audit requirements
4.7 People's Republic of China (PRC)
4.7.1 PRC: managing changes
4.7.2 PRC: clinical evaluation requirements
4.7.3 PRC: audit requirements
4.8 Russia
4.8.1 Russia: managing changes
4.8.2 Russia: clinical evaluation requirements
4.8.3 Russia: audit requirements
4.9 United States of America (USA)
4.9.1 USA: managing changes
4.9.2 USA: clinical evaluation requirements
4.9.3 USA: audit requirements
5 Managing changes that can impact the DCP
5.1 Introduction
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 (during submission)
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 Australia
4.1.1 Australia: managing changes
4.1.2 Australia: clinical evaluation requirements
4.1.3 Australia: audit requirements
4.2 Brazil
4.2.1 Brazil: managing changes
4.2.2 Brazil: clinical evaluation requirements
4.2.3 Brazil: audit requirements
4.3 Canada
4.3.1 Canada: managing changes
4.3.2 Canada: clinical evaluation requirements
4.3.3 Canada: audit requirements
4.4 European Union (EU)
4.4.1 EU: managing changes
4.4.2 EU: clinical evaluation requirements
4.4.3 EU: audit requirements
4.5 India
4.5.1 India: managing changes
4.5.2 India: clinical evaluation requirements
4.5.3 India: audit requirements
4.6 Japan
4.6.1 Japan: managing changes
4.6.2 Japan: clinical evaluation requirements
4.6.3 Japan: audit requirements
4.7 People's Republic of China (PRC)
4.7.1 PRC: managing changes
4.7.2 PRC: clinical evaluation requirements
4.7.3 PRC: audit requirements
4.8 Russia
4.8.1 Russia: managing changes
4.8.2 Russia: clinical evaluation requirements
4.8.3 Russia: audit requirements
4.9 United States of America (USA)
4.9.1 USA: managing changes
4.9.2 USA: clinical evaluation requirements
4.9.3 USA: audit requirements
5 Managing changes that can impact the DCP
5.1 Introduction
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 (during submission)
5.3 Interactions with region-specific regulatory authorities – post commercialization
Bibliography