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Working Towards Harmonization in Medical Device Regulation

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5th APEC-Funded Seminar on Harmonization of Medical Device Regulations - Slide Presentations

All documents are in Adobe PDF format.

• Thursday
  • Dr. R.G. Rotter - The Global Harmonization Task Force: Overview and Status
  • Dr. Meghal Khakhar - Role of Distributor in Global Harmonization and Integrity of Medical Device Supply Chain
  • Jos Kraus - Legislation, Regulators and the Safety of the Distribution Chain
  • Miang Tanakasemsub - The role of regulators, industry, and distributors in global medical device regulatory harmonization and the integrity of the medical device supply chain
  • Greg LeBlanc - Global Harmonization Task Force Study Group 5
• Friday
  • Michael C. Morton - Principles of Medical Device Classification
  • Maria Carballo - Classification of In vitro Diagnostic Devices (IVDs)
  • QUIZ – Classification of IVDs
  • Brenda Murphy - Introduction to Summary Technical Documentation (STED)
  • Maria Carballo - STED Implementation, The Canadian Experience
  • Dr. Petra Kaars-Wiele - Proposed Document - Definitions of the Terms Manufacturer, Authorised Representative, Distributor and Importer
  • Brenda Murphy - Proposed Document - Registration of Manufacturers and other Parties and Listing of Medical Devices
  • Dr. Ekkehard Stösslein & Dr. Philippe Auclair - GHTF SG2 Guidance: Reporting of Medical Device Adverse Events
  • Ekkehard Stösslein & Jorge Garcia & Mark Segstro & Deborah Yoder - GHTF SG2: National Competent Authority Report Program
• Saturday
  • Egan Cobbold & Gunter Frey
    • GHTF SG3 Training (Quality Systems)
    • SG3/N15R8/2005 Implementation of Risk Management Principles and Activities Within a Quality Management System
    • Process Validation Guidance GHTF/SG3/N99-10:2004
    • SG3/N17R9/2009 Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers - A Status Update and Introduction
  • Armand Tsai & Albert T.W. Li - Introduction to Global Harmonization Task Force Study Group 4 Regulatory Auditing
  • SG4 Case Studies

Updated 5 June 2009

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