GHTF: United we stand Industry and Regulators

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GHTF United we standIndustryand Regulators

• Jos Kraus
• Inspectorate of Health Care
• The Hague The Netherlands

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One EU market ONE Directive

• gt 27 Cas plus Swiss and EFTA
• gt80 NBs
• Local differences
• Italy
• Netherlands
• Germany
• Spain
• USA
• New York vs. California

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GHTF

• Global Harmonisation Task Force
• From
• Tested everywhere sold nowhere
• To
• Tested once sold everywhere
• Ending up in
• Tested somewhere sold somewhere

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Historical starting point

• EU 93/47
• USA PMA and 510 K
• Japan Pharma (early GHTF mandatory)
• Aus EU approach with PMA listing
• Ca EU (ISO 13485) with PMA listing

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Jap
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GHTF successes

• Essential requirements
• STED
• Classification
• Auditing
• Third party
• Regulator
• CA and a third party, or
• CA and a manufacturer
• Vigilance and NCAR
• Clinical study

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Unanimous divided

• GHTF on High level definition
• A standard body on legislation
• Keeping the difference as the where
• Requirements in detail, where possible, or
• Broad and global terms where systems differ
• One size fits all
• Not custom made
• But customised

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GHTF Global Model
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GHTF Global Model
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GHTF Global Model
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Conclusion

• GHTF did harmonise the world of the devices,
• GHTF is not one universal system,
• Local differences will always occur,
• One size fits all A too easy concept,
• Regulators will always adapt a system that fits
  the best within their
• legal framework,
• culture,
• enforcement strategy, and
• major incidents from the past