Recommendation 2 The committee recommends that the Department of Health and Ageing implement Recommendation 8c of the Health Technology Assessment Review regarding the need for increased rigour of regulatory assessment of higher-risk medical devices. Government response: Agreed. Recommendation 3 The committee recommends that the of assessment of Class III medical devices be increased. Agreed to consult further with affected stakeholders. Government response: Recommendation 4 The committee recommends that the Therapeutic Goods Administration investigate whether allowing an increasing number of medical devices onto the Australian market actually improves clinical outcomes; and whether a more judicious approach could improve premarket assessment and postmarket surveillance of higher risk medical devices, for the ultimate benefit of patients. Government response: Agreed with the intent, to improve the quality of medical devices available in the Australian market place, by continuing to refine requirements for premarket assessment and postmarket surveillance. Recommendation 5 The committee recommends that the Therapeutic Administration continue to consult widely with stakeholders, including consumer health organisations, on the amended proposals related to third party conformity assessment; and weigh carefully considerations of the advantages of streamlined international regulatory frameworks and patient safety. Government response: Agreed. Recommendation 7 The committee recommends that the Department of Health and Ageing implements Recommendations 13, 14, and 15 of the Health Technology Assessment Review in a timely manner. These recommendations address the need for improved postmarket surveillance by increasing the rate of reporting of adverse events, including by health service providers and consumers; facilitating the expansion and use of postmarket surveillance data to inform safety, effectiveness and reimbursement decisions; and establishing further clinical registers for high risk implantable devices and procedures. Government response: Agreed in principle. Further information on the Inquiry, including transcripts of public hearings, submissions made to the committee, the Committee’s report and the Government’s response, are available at the Medical Devices Inquiry website at <>.
Recommendation 2 The committee recommends that the Department of Health and Ageing implement Recommendation 8c of the Health Technology Assessment Review regarding the need for increased rigour of regulatory assessment of higher-risk medical devices. Government response: Agreed. Recommendation 3 The committee recommends that the of assessment of Class III medical devices be increased. Government response: Agreed to consult further with affected stakeholders. Recommendation 4 The committee recommends that the Therapeutic Goods Administration investigate whether allowing an increasing number of medical devices onto the Australian market actually improves clinical outcomes; and whether a more judicious approach could improve premarket assessment and postmarket surveillance of higher risk medical devices, for the ultimate benefit of patients. Government response: Agreed with the intent, to improve the quality of medical devices available in the Australian market place, by continuing to refine requirements for premarket assessment and postmarket surveillance. Recommendation 5 The committee recommends that the Therapeutic Administration continue to consult widely with stakeholders, including consumer health organisations, on the amended proposals related to third party conformity assessment; and weigh carefully considerations of the advantages of streamlined international regulatory frameworks and patient safety. Government response: Agreed. Recommendation 7 The committee recommends that the Department of Health and Ageing implements Recommendations 13, 14, and 15 of the Health Technology Assessment Review in a timely manner. These recommendations address the need for improved postmarket surveillance by increasing the rate of reporting of adverse events, including by health service providers and consumers; facilitating the expansion and use of postmarket surveillance data to inform safety, effectiveness and reimbursement decisions; and establishing further clinical registers for high risk implantable devices and procedures. Government response: Agreed in principle. Further information on the Inquiry, including transcripts of public hearings, submissions made to the committee, the Committee’s report and the Government’s response, are available at the Medical Devices Inquiry website at <>.