Medical Technology Abolish TGA conformity assessment for all classes of Option 2 Proposal C now proposed the abolition of the Association of New Zealand medical devices to prevent disadvantage to Australian requirement for TGA conformity assessment for all companies. Australian manufacturers Professor Guy Ludbrook Success of the proposal depends on quality of overseas For this reason Proposal A and Proposal C are linked. conformity assessment Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers. ResMed Ltd Clarification required whether this will prevent All types of conformity assessment certificates will still be manufactures obtaining quality system certification offered by the TGA. from the TGA- thus impacting supply in Southeast Asia and American countries. Supportive of these changes for all classes of device. Stryker Pacific Supports- Make use of Notified Bodies ASAP William A Cook Australia Pty Should extend to Class III, AIMD and Class IIb Option 2 Proposal C now proposed the abolition of the Ltd implantable devices as well and then undergo a Level 3 requirement for TGA conformity assessment for all application audit. Australian manufacturers. Manufacturers relying on EU certification are subject to greater when applying for inclusion on the ARTG than those holding TGA or MRA conformity assessment certification, and this may include audit requirements. Name withheld at submitters Supports proposal as is request
Medical Technology Association of New Zealand Abolish TGA conformity assessment for all classes of medical devices to prevent disadvantage to Australian companies. Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers Professor Guy Ludbrook Success of the proposal depends on quality of overseas conformity assessment For this reason Proposal A and Proposal C are linked. Proposal A provides assurance in the conformity assessment of higher risk devices. This, together with MRA confidence building to be undertaken during 2014 and 2015, provides greater premarket scrutiny of higher risk devices (whether manufactured in Australian or overseas) which enables this change for Australian manufacturers. ResMed Ltd Clarification required whether this will prevent manufactures obtaining quality system certification from the TGA- thus impacting supply in Southeast Asia and American countries. Supportive of these changes for all classes of device. All types of conformity assessment certificates will still be offered by the TGA. Stryker Pacific Supports- Make use of Notified Bodies ASAP William A Cook Australia Pty Ltd Should extend to Class III, AIMD and Class IIb implantable devices as well and then undergo a Level 3 application audit. Option 2 Proposal C now proposed the abolition of the requirement for TGA conformity assessment for all Australian manufacturers. Manufacturers relying on EU certification are subject to greater when applying for inclusion on the ARTG than those holding TGA or MRA conformity assessment certification, and this may include audit requirements. Name withheld at submitters request Supports proposal as is
consult-ris-medical-devices-premarket-assessment-130510-1.docx