governmental regulation of medical devices
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7/31/2019 Governmental Regulation of Medical Devices
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Governmental
regulation ofmedicaldevicesManuel Muñoz 20048
Mario Montoya 20405
Sonia Velázquez 23379
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Critical elements for regulatoryattention
• Pre-market review• Post market surveillance• Representation of the product to the user
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•
Pre-market: product complies with regulatoryrequirements• Advertising: correct product representation.• Post-market: continued safety and performance of
devices.
Stages of regulatory control
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Framework for medical deviceregulation
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Regulatory tools and general
requirements
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Product control• All medical devices must satisfy safety and
performance, quality system and labelling
requirements.• Degree of scrutiny increases with device risk.
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Vendor establishment control• Vendor information facilitates governments in
tracking medical device sales.• Examples:
• Australia: Enterprise ID Number • Canada: Permission• European Union: Registered address.• Japan: Hanbai-Gyoo / Hanbai Todoke• USA: FDA
• Post-market surveillance mandatory.
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Post-market surveillance
• Continuous assessment of medical deviceperformance.
• Safety and performance problems occur through
actual use.
• Two most important activities:• Surveillance
• Adverse event reporting: structured datacollections.
• All device-related events that have resulted in seriousinjury or death must be reported.
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Quality systems
• Is defined as the organizational structure,responsibilities, procedures, processes and resourcesneeded to implement quality management.
• International Organization for Standardization (ISO)• ISO13485:1996 includes requirements for medical
devices. (Includes 9001 + extra)• New ISO13485:200? is currently being developed.
• Includes: Manufacture, packaging, labelling,storage, installation, servicing, post-market handling.
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• The key advantage regarding quality systems
is that they represent a preventive approachto assuring medical device quality.
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GlobalHarmonzationTask Force
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Objectives
• Need to harmonize national standards in orden tominimize regulatory barriers, facilitate trade andimprove access to new technologies.
• GHTF was founded in 1993 by the governments andindustries of Australia, Canada, Japan, EuropeanUnion, USA.
•
Encourage a convergence in standards andregulatory practices related to safety, performanceand quality of medical devices.
• Documents for regulatory practices.
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Scope of 4 GHTF groups
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GHTF Benefits
• Countries ensure their regulations are equivalentto other countries’.
• Safety performance issues are examined by
experts.
• GHTF creates international data bank for deviceinformation.
• International trade is enhanced.
• Provides an opportunity for countries to adoptcertain regulations.
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Global Medical DeviceNomenclature
• Consistence in nomenclature is fundamental for
harmonization.
• CEN: Comité Européen de Normalisation produces anomenclature standard.• Give a common generic device description for
every general term.• Identify devices using the generic term.