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

Medical Device Regulatory, Reimbursement and Compliance Congress

Medical Device Development

Medical Device Localisation

Medical Device Companies Antitrust Compliance Programmes

GMDN Global Medical Device Nomenclature

2006 DEVICE FRAUD ISSUES THE MEDICAL DEVICE REGULATORY AND COMPLIANCE CONGRESS

First International Medical Device Compliance Congress and Best Practices Forum

Medical Device Sector

The First International Medical Device Compliance Congress May 27, 2008 - Paris, France

The Third Annual Medical Device Regulatory, Reimbursement and Compliance Congress

Medical Device Congress AdvaMed’s Efforts to Promote Compliance

Medical Device Training

Device Congress

Medical Device Development

Medical Device Resources

Medical Device Distributor | Medical Device Marketing

Global Medical Device Labeling Market

Medical Device Regulation: Implications for Medical Device Manufacturers.

Medical Device Vigilance

Medical device

Medical Device Suppliers, Medical Device Market Trends

Medical Device