Complete GHTF Guidance Document Bundle

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Complete GHTF Guidance Document Bundle

The Global Harmonization Task Force Bundle comprises 24 guidances for medical devices: 10 from Study Group 1, eight from Study Group 2, three from Study group 3, two from Study Group 4 and one from Study Group 5.

This bundle includes:

  • SG1-N46:2008, Principles of Conformity Assessment for In Vitro Diagnostic (IVD) Medical Devices
  • SG1-N45:2008, Principles of In Vitro Diagnostic (IVD) Medical Devices Classification
  • SG1-N11:2008, Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices (STED)
  • SG1-N44:2008, Role of Standards in the Assessment of Medical Devices
  • SG1-N15:2006, Principles of Medical Device Classification
  • SG1-N40:2006, Principles of Conformity Assessment for Medical Devices
  • SG1-N43:2006, Labeling for Medical Devices
  • SG1-N29R16:2005, Information Document Concerning the Definition of the Term "Medical Device"
  • SG1-N41R9:2006, Essential Principles of Safety & Performance of Medical Devices
  • SG1-N55:2009, Definition of the Terms Manufacturer, Authorised Representative, Distributor and Importer
  • SG2-N54R8:2006, Medical Devices Postmarket Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices
  • SG2-N57R8:2006, Medical Devices Postmarket Surveillance: Content of Field Safety Notices
  • SG2-N47R4:2005, Review of Current Requirements on Postmarket Surveillance
  • SG2-N68R3:2005, Summary of Current Requirements for Where to Send Adverse Event Reports
  • SG2-N6R3, Comparison of the Device Adverse Reporting Systems in USA, Europe, Canada, Australia & Japan
  • SG2-N8R4, Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices
  • SG2-N38R19, Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program
  • SG2-N79R11:2009, Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
  • SG3-N17:2008, Quality Management System—Medical Devices—Guidance on the Control of Products and Services Obtained from Suppliers
  • SG3-N15R8:2005, Implementation of Risk Management Principles and Activities Within a Quality Management System
  • SG3-N99-10, Quality Management Systems—Process Validation Guidance
  • SG4-N28R4:2008, SG4-N30R20:2006, SG4-N33R16:2007, Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers
  • SG4(00)3, Training Requirements for Auditors
  • SG5-N2R8:2007 and N1R8, Clinical Evaluation and Clinical Evidence—Key Definitions and Concepts

Who should use this publication?

Regulatory professionals working within the complex web of Global Harmonization Task Force guidances will find this an indispensible resource.