Guidance Documents | GHWP

Quality Management System-Medical Devices Requirements for Distributors, Importers and Authorized Representatives

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MDSAP Assessment and Decision Process for the Recognition of an Auditing Organization

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Competence and Training Requirements for Auditing Organizations

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Requirements for Medical Device Auditing Organizations for Regulatory Authority Recognition

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MDSAP: Overview of Auditing Organization Assessment and Recognition Decision Related Processes

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Guidelines for Adverse Event Reporting of Percutaneous Coronary Intervention (PCI) devices for the Medical Device Manufacturer or its Authorized Representative

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AHWP Safety Alert Dissemination System (SADS)

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Guidance document on Risk Categorisation of Software as a Medical Device

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Definition of the Terms “Medical Device” and “In Vitro Diagnostic (IVD) Medical Device”

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Submission Dossier for Demonstrating Conformity to the Essential Principles of Safety and Performance of In Vitro Diagnostic Medical Devices

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