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BEST INTERNATIONAL PMS PRACTICE
AND IN-COUNTRY IMPLEMENTATION OF
PMS SYSTEMS.
Shelley Tang
November 2013
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Post-Market Surveillance
• Post-Market Surveillance is the collection of
information on the quality, safety or performance
of medical devices after they have been placed in
the market.
• A balanced Post-Market Surveillance system will
contain an appropriate mix of proactive and
reactive activities.
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Post-Market Vigilance
• (Post-Market) Vigilance is the reporting and investigation of medical device adverse events and incidents. Both the manufacturer and the Regulatory Authority play major roles.
• By its very nature, Vigilance is a REACTIVE activity (the manufacturer or authority receive reports and REACT to them)
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A pictorial view of PMS
Post Market
Surveillance
Vigilance(adverse event
report
investigation)
Post-Market Surveillance
Information is used for:
Injury prevention
Development of standards
Regulatory refinement
Product improvement
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The GHTF Model
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SG2 GuidanceAdverse Event Reporting by Manufacturers
GHTF SG2 N54R8
• Adverse Event Reporting Guidance for the Medical Device Manufacturer or its Authorized Representative
• Reporting of Use Errors with Medical Devices by their Manufacturer or Authorized Representative
• Universal Data Set for Manufacturer Adverse Event Reports
• Manufacturer's Trend Reporting of Adverse Events
• Timing of Adverse Event Reports
• Who Should Adverse Event Reports be Sent To?
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SG2 Guidance
Report Handling & NCAR Program
• SG2-N8R4: Guidance on How to Handle Information Concerning Vigilance Reporting Related to Medical Devices
• SG2-N79R11: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
– Global Medical Device Competent Authority Reports
– National Competent Authority Report Exchange Criteria
• SG2-N38R19 Application Requirements for Participation in the GHTF National Competent Authority Report Exchange Program.
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SG2 GuidanceOther documents & guidance
• SG2-N6R3: Comparison of the Device Adverse Reporting Systems
in USA, Europe, Canada, Australia & Japan
• SG2-N16R5: SG2 Charge & Mission Statement
• SG2-N12R4: Précis
• SG2-N47R4: Review of Current Requirements Regarding Post-
market Surveillance
• SG2-N57R8: Content of Field Safety Notice
• SG2-N61R6: PMS Harmonisation Chart
GHTF documents now available on the IMDRF website www.imdrf.org
Archived
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International cooperation
• GHTF National Competent Authority Report
Exchange (NCAR) – under review
• AHWP Safety Alert Dissemination System (SADS)
• Agreements for exchange of information between
individual regulators
• Confidentiality issues
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Challenges
• Mandatory reporting – who?
• Education of reporters
• Ease of reporting
• Managing information and investigations
• Feedback into pre-market programme
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THANK YOU