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BSI PD ISO/TR 12417-2:2022

BSI PD ISO/TR 12417-2:2022

$167.15

Cardiovascular implants and extracorporeal systems. Vascular device-drug combination products – Local regulatory information

Published By Publication Date Number of Pages
BSI 2022 38
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 Information on device- and drug-related aspects — Applicable documents for local guidance
4.1 General
4.2 Australia
4.2.1 General
13 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
14 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
15 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
16 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
17 4.8.2 PRC: Clinical evaluation requirements
18 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
19 4.10.2 USA: Clinical evaluation requirements
4.10.3 USA: Audit requirements
20 5 Managing changes that can impact the DCP
5.1 General
5.2 Change evaluation
5.2.1 Identify changes
21 5.2.2 Risk evaluation
5.2.3 Guidance for change evaluation
22 5.2.4 Pre-market
5.3 Interactions with region-specific regulatory authorities — Post-commercialization
30 Bibliography

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BSI PD ISO/TR 12417-2:2022
$167.15