proposed amendments to the regulatory model and will continue to occur throughout the implementation phase. The table below summarises how each proposed option addresses the key issues identified in the Problem section above and the objectives identified in the section above: Option 1 Option 2 Option 3 Key issues (as outlined in the section from page 12) Increased level of premarket scrutiny AIMD and Class III Not addressed Level 3 audit Expanded implantable requirement for TGA conformity assessment Class IIb implantable Not addressed Expanded Expanded mandatory mandatory audit audit requirement requirement Transparency of Not addressed Publication of Publication of decision making TGA decisions TGA decisions Requirements for TGA Not addressed Abolition of Abolition of conformity assessment requirement requirement for Australian manufacturers Objectives (as outlined in the section from page 14) Primary objective: greater assurance that Not addressed Level 3 audit Expanded higher risk medical and expanded requirement for devices approved do not mandatory TGA conformity compromise public audit assessment health and safety requirement Secondary objectives: (a) timely availability No changes to Audits will TGA conformity of medical devices timeframes for extend times assessment will availability frames for extend times targeted frames for devices (weeks targeted to months) devices (months to years) (b) minimising No changes to Increases Greater regulatory burden regulatory regulatory increase to and costs burden and no burden and regulatory additional significant burden and additional costs very significant additional costs
proposed amendments to the regulatory model and will continue to occur throughout the implementation phase. The table below summarises how each proposed option addresses the key issues identified in the Problem section above and the objectives identified in the section above: Option 1 Option 2 Option 3 Key issues (as outlined in the section from page 12) Increased level of premarket scrutiny AIMD and Class III implantable Not addressed Level 3 audit Expanded requirement for TGA conformity assessment Class IIb implantable Not addressed Expanded mandatory audit requirement Expanded mandatory audit requirement Transparency of decision making Not addressed Publication of TGA decisions Publication of TGA decisions Requirements for TGA conformity assessment for Australian manufacturers Not addressed Abolition of requirement Abolition of requirement Objectives (as outlined in the section from page 14) Primary objective: greater assurance that higher risk medical devices approved do not compromise public health and safety Not addressed Level 3 audit and expanded mandatory audit requirement Expanded requirement for TGA conformity assessment Secondary objectives: (a) timely availability of medical devices No changes to timeframes for availability Audits will extend times frames for targeted devices (weeks to months) TGA conformity assessment will extend times frames for targeted devices (months to years) (b) minimising regulatory burden and costs No changes to regulatory burden and no additional Increases regulatory burden and significant additional costs Greater increase to regulatory burden and very significant additional costs
consult-ris-medical-devices-premarket-assessment-130510-1.docx