Medical Device Compliance Congress: Global Device Codes Roundtable - Australia Anne Trimmer

Medical Device Compliance Congress: Global Device Codes Roundtable - Australia Anne Trimmer

Agenda • Background to 3rd Edition • Advertising and claims • Dealings with healthcare professionals • Company representatives • Complaints • Code monitoring

Background to 3rd Edition • Initial implementation 2 years ago • First complaint and appeal • Language issues • Increased compliance focus globally • Inconsistencies with AdvaMed Code and many member internal codes

Headline news • Law on ties between surgeons, device makers insufficient • Kickback claims being taken 'very seriously' • Hip bones and hip pockets • Group calls for ethical conduct plan for Australian device makers

Advertising – 3 tiers • Regulation • Therapeutic Goods Act and Regulations, Trade Practices Act • Co-Regulation • Therapeutic Goods Advertising Code • Self-regulation • Company codes • Voluntary industry codes • MTAA/MIANZ Code

Dealings with healthcare practitioners • Definitions • Healthcare Practitioner • Other Professional • Member-sponsored training and education • Third party educational conferences • Member-sponsored symposia • Hospitality

Dealings with healthcare practitioners • Hospitality and gifts • Consultancy arrangements • Donations and philanthropic gifts • Competitions for healthcare practitioners • Market research

Company representatives • Requirement for ethical conduct • Not compromise professional independence of healthcare practitioner • Compliance with institutional standards, codes and laws • Requirement for every representative within 6 months and 3 year refresher • Training must be approved by MTAA

Code complaints • Strengthened committee structure for complaints and appeals • Panel of 12 and independent chair: • Healthcare practitioners • Institutions • Consumer representatives • Industry

Code complaints • Complaints from industry and non-industry • Industry must first raise with other member • Complaints committee may call on expert assistance • Breaches range from minor to serial • Maximum fine of $75,000 • Power to notify regulator

Code monitoring • In addition to complaints process • Proactive monitoring – may call for material • Independent chair • May call for material or outline of activity

Medical Device Compliance Congress: Global Device Codes Roundtable - Australia Anne Trimmer

Medical Device Compliance Congress: Global Device Codes Roundtable - Australia Anne Trimmer

Presentation Transcript

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Medical Device Development

Medical Device Localisation

Medical Device Companies Antitrust Compliance Programmes

GMDN Global Medical Device Nomenclature

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First International Medical Device Compliance Congress and Best Practices Forum

Medical Device Sector

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The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress

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Medical Device Development

Medical Device Resources

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Medical Device Vigilance

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Medical Device Suppliers, Medical Device Market Trends

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Medical Device regulation