澳洲注册申请表中涉及的问题.doc

问题是下面标批注的三个问题Device - HTA Questions Changes to the Medical Device Application form for inclusions BackgroundHealth Technology Assessment for ReimbursementThe TGA assesses applications for entry of therapeutic goods including medical devices and in vitro diagnostic medical devices (IVDs) on the Australian Register of Therapeutic Goods (ARTG) to enable supply in Australia.A sponsor or manufacturer may seek public or private funding for a therapeutic good under an Australian Government funding program either once the good is approved for supply or at some time in the future.Funding programs that use health technology assessment (HTA) to inform whether a therapeutic good should be listed for funding include: Pharmaceutical Benefits Scheme (PBS) for pharmaceuticals National Immunisation Program (NIP) for vaccines Medicare Benefits Schedule (MBS) for health technologies requiring a medical procedure Prostheses List for private health insurance funding of prostheses National Blood Agreement for blood and blood productsUnder the HTA process, health technologies are assessed in regard to their comparative clinical effectiveness and cost effectiveness. This aims to ensure that taxpayers money is used to support the health care interventions that achieve the maximum health improvement at the lowest cost.Each of the above programs has a website that provides information about the funding program, eligibility criteria, making application and assessment processes. Entry on the ARTG is one of the eligibility criteria that must be met before a therapeutic good can be listed for funding. Applicants seeking funding under any of these programs are encouraged to review the relevant website and/or contact the appropriate secretariat prior to making an application.Co-dependent or hybrid technologiesSome therapeutic goods can be co-dependent (for example, a drug/diagnostic test combination) or hybrid technologies (for example, a medical device with an integrated drug) and may therefore need to be considered for eligibility under two or more of these funding programs. Co-dependent technologies are therapeutic goods that are dependent on another technology, either to achieve their intended effect or to enhance their intended effect (for example, in-situ hybridisation (ISH) testing related to eligibility for trastuzumab (Herceptin) for the treatment of breast cancer). Hybrid technologies are considered to be therapeutic goods where the characteristics of different health technologies (for example, a medicine or a medical device or a biologic) are combined in one intervention (for example, drug eluting stents).The Department of Health and Ageing has established the Health Technology Assessment Access Point (HTAAP) to assist manufacturers or sponsors who may intend to apply for funding for a co-dependent or hybrid technology under the MBS, PBS and/or Prostheses List, or a technology where the assessment pathway through these existing HTA processes is uncertain.The HTAAP can be contacted at:HTAAP email: HTA.auHTAAP phone: (02) 6289 7550What do these additional questions mean?Coordinating assessment activities and outcomesSponsors or manufacturers intending to apply for HTA for reimbursement under one of these programs either concurrently with or following the TGA assessment are encouraged to tick the relevant box(es) below. By doing this, an email will be sent to the relevant secretariat advising this intention, and also at the completion of the TGAs assessment for entry on the ARTG. This will assist with coordinating the assessment of applications across the different processes.Will you be applying for listing of this product, or procedure in the Medicare Benefit Schedule (MBS)?Yes NoWill you be applying for listing of this product on the Prosthesis List?Yes NoWill you be applying for listing of this product on the Co-dependent or hybrid technology application list? Yes No胥经理：旋转式Y接头澳洲注册的制造商证据已经审核过了，下一步是提交申请，可是申请表中涉及的这三个问题不知怎么选，您看应该怎么选择一下啊？Where the government decides not to reimburse a new technology under one or more of these funding programs, it will remain available for supply within the Australian market provided it has been entered on the ARTG.If you answer No to any of these questions on this form, it does not prevent you from making an application directly to the relevant area of DoHA at a later date.Please note that answering Yes to any of these questions does not prioritise your medical device application for Inclusion in the Australian Register of Therapeutic Goods (ARTG).By answering Yes you are also allowing the relevant secretariat(s) of the reimbursement committees to access any relevant data from your device application, including any material that is covered by the certification made under section 41FD (Matters to be Certified) of the Therapeutic Goods Act 1989.This includes but is not limited to any material that could be required by the TGA to demonstrate that an appropriate Conformity Assessment Procedure has been applied to the manufacture of the device or to demonstrate compliance with the Essential Principles.Please note that you may also be contacted directly by the relevant secretariat(s) for additional information.Sponsors are reminded to take into account the Therapeutic Goods Administration target timeframes for medical device applications when submitting application to meet the deadlines of other HTA agencies.Australian Government HTA websiteIn mid 2010, the Department for Health and Ageing also established a cent