（五）创新医疗器械应用示范项目
Directly retrieved body; publication date not established. Only device-related tracks are in scope; drug-only projects excluded.
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Programme evidence / 苏州
Device-related tracks in the municipal advanced-manufacturing fund; exclude drug-only projects. Product approval is not a funding award.
Window: 2020–2026; earlier legal bases can be included as context. Reviewed source labels confirm programme association and document stage. They do not confirm current legal force or payment. Allocation, eligibility and payment are separate meanings; no cross-instrument monetary total is calculated.
Blank years are not evidence that a programme did not operate. Cross-year rules and notices without an established round year appear below.
| Round | Policy basis | Implementing rules | Applications | Proposed recipients | Final allocations | Settlement / recovery | Evaluation / renewal |
|---|---|---|---|---|---|---|---|
| 2026 | — | — | — | — | — | — | — |
| 2025 | — | — | 1 reviewed | — | — | — | — |
| 2024 | — | — | — | — | — | — | — |
| 2023 | — | — | — | — | — | — | — |
| 2022 | — | — | — | — | — | — | — |
| 2021 | — | — | — | — | — | — | — |
| 2020 | — | — | — | — | — | — | — |
Source-specific rules; historical versions and exceptions may differ. These are not an automated eligibility decision.
（五）创新医疗器械应用示范项目 1.支持方向。支持2020年1月1日之后首次获批上市的第三类医疗器械，进行临床应用评价，开展创新医疗器械应用与推广，形成“应用示范-反馈改进-水平提升-辐射推广”效应。 2.支持条件。 （1）由生产企业、医疗机构、科研院所等单位组成“1+1+N”联合体共同申报，其中：1家本市医疗器械生产企业和1家本市医院联合牵头，N家医疗机构、研究单位、配套企业等共同参与（“N”可吸纳部分市外单位参与）。 （2）牵头企业为第二、三、四批《苏州市生物医药及健康产业创新名优产品推广应用目录》内的本市器械生产企业，有固定的生产和研发场地，有专职核心研发团队；牵头医疗机构原则上应为本市三级甲等医院，具有使用示范器械的合规条件，具有与示范器械相应的科室，器械配备齐全，人员资质完备，有相应工作基础及使用经验，愿意配合企业开展临床应用验证，并能协助开展示范器械的推广、培训等工作。 （3）申报应用示范创新医疗器械条件：产品已取得医疗器械注册证和生产许可证；产品主要工作原理或者作用机理创新性较高，具有较高临床应用价值；产品纳入《苏州市生物医药及健康产业创新名优产品目录》（第二、三、四批）。 （4）项目实施期原则上不超过3年。 3.考核指标。 （1）推动产品入院。任务期内推动申报医疗器械进入牵头及参与医疗机构入院应用； （2）临床应用评价。制定临床应用评价方案，开展相关真实世界数据分析，医疗机构开展不少于100例应用数据收集，对功能、性能、可靠性、可用性、经济性、临床效果等进行评价，形成应用评价报告，并发表高水平文章； （3）建立评价体系。结合各自领域，建立创新医疗器械使用规范或技术规范或评价指标体系等，制定专家共识或诊疗指南等； （4）产品完善提升。医疗机构提出创新医疗器械改进建议，企业改进提升医疗器械质量性能，并形成新一代样品； （5）产品宣传推广。每年开展不少于2次、项目期内不少于6次创新医疗器械产品宣传和推广，推动产品在其他医疗机构入院应用；每年开展不少于2次、项目期内不少于6次创新医疗器械使用人员培训，培养一批专业技术人才队伍； （6）申报主体参与共同研制，形成产医融合创新成果。 4.扶持标准。事前支持项目，根据示范应用项目立项资金的20%择优给予奖励，首次拨付补助资金总额的50%，通过验收审核后，再拨付剩余50%资金。每项不超过100万元。Original source →
No evidence linked for this stage. See the search audit below; absence has not been established.
No evidence linked for this stage. See the search audit below; absence has not been established.
（五）创新医疗器械应用示范项目
Directly retrieved body; publication date not established. Only device-related tracks are in scope; drug-only projects excluded.
Original source ↗No evidence linked for this stage. See the search audit below; absence has not been established.
No evidence linked for this stage. See the search audit below; absence has not been established.
No evidence linked for this stage. See the search audit below; absence has not been established.
No evidence linked for this stage. See the search audit below; absence has not been established.
Amounts retain their source meaning and unit. Proposed support and allocations are not confirmed payments. Candidate rows require source review.
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| Recipient / project | Round / supported period | Amount | Meaning | Evidence |
|---|---|---|---|---|
| No recipient observations linked yet. | ||||
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