Managing Medical Device Industry Innovation and Entrepreneurship in China

Zhang Kaiwen

doi:doi:10.11648/j.si.20251306.19

Research Article |

| Peer-Reviewed

Managing Medical Device Industry Innovation and Entrepreneurship in China

Zhang Kaiwen^*

Published in Science Innovation (Volume 13, Issue 6)

Received: 27 October 2025 Accepted: 1 December 2025 Published: 24 December 2025

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Abstract

Focusing on mainland China, this paper builds an integrated framework for medical device innovation management and entrepreneurship aligned with NMPA/CMDE practice, DRG/DIP payment reforms, and volume-based procurement. We translate compliance requirements—such as device classification, clinical evaluation protocols, quality and risk management systems (including standards like YY/T 0316, YY/T 0664, and GB 9706), unique device identification (UDI), and post-market surveillance—into a comprehensive compliance-by-design operating model that emphasizes proactive risk mitigation and regulatory adherence. This framework incorporates stage-gate governance processes to manage development milestones, risk-adjusted valuation methods to assess financial viability, and portfolio optimization strategies to prioritize high-impact projects. Additionally, we align evidence generation with business objectives to facilitate hospital entry and tendering processes, ensuring that clinical data supports market access and reimbursement decisions. A detailed China-specific case study of a portable hemodynamic monitor illustrates how early engagement with regulatory bodies for scientific advice, real-world pilot studies, and results-based contracting can significantly enhance expected value projections and reduce time-to-access for patients. The paper concludes by exploring policy options to foster innovation, including the establishment of software as a medical device (SaMD) and artificial intelligence (AI) sandboxes for testing, broader acceptance of real-world evidence (RWE) in regulatory decisions, and health technology assessment (HTA) capacity building to support evidence-informed policymaking and sustainable healthcare innovation.

Published in	Science Innovation (Volume 13, Issue 6)
DOI	10.11648/j.si.20251306.19
Page(s)	190-193
Creative Commons	This is an Open Access article, distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium or format, provided the original work is properly cited.
Copyright	Copyright © The Author(s), 2025. Published by Science Publishing Group

Keywords

Medical Devices, NMPA, Innovation Management, Entrepreneurship, DRG/DIP, Portfolio Optimization

1．引言

中国医疗器械行业正在发生结构变化。需求端，因为人口老龄化加快、慢性病增多、急危重症救治需求也在增加，所以市场需求在涨。供给端，因为数字化推进和国产替代加快，所以更新更快。两边的变化在临床一线相遇，推动“更安全、效果更好、成本更低”的方案更快落地。对创业团队来说，难点不在做出原型，而在于建好可追溯的标准体系，顺利通过监管审评，用足够的证据支持支付决定，并且能在不同医院和科室复用

[1-3, 10-12]

。

把从概念到商业化看成一道道闸门，每个环节都可能卡住：注册可能卡在同品种对比证据上；院内准入可能卡在互联互通和网络安全上；集采谈判常常看服务能力和可比价格。同时，DRG/DIP 等新的支付方式正在改变医院的成本结构和采用动力。

基于这些情况，建议用工程化的方法重新设计创新流程。把监管策略前置，并把它变成设计输入，而不是到最后再补。把质量和风险管理嵌入全流程，和需求变更、版本节点一起触发，而不是在归档时补录。让证据规划和商业模式一起设计，用可以量化的临床结局和过程指标来支撑价值。

通过阶段闸门和项目组合管理，明确资源怎么分配、什么时候退出，避免“僵尸项目”消耗现金流

[12-15]

。

2．法规与质量体系

2.1．分类、路径与审评要点

医疗器械监管中，监管方和企业互动越来越多，所以政策制定和执行要更灵活，也要更能适应变化。监管方发布指导原则和指南，为开发和评价提供清晰的框架

[1-3, 15]

。监管方也鼓励企业参与制定标准，用来推动技术进步和行业自律

[20]

。在实际工作中，预提交会议和快速反馈等沟通方式，能给产品开发提供及时的指导和建议，也能加快创新产品上市

[2-4]

。

医疗技术发展很快，医疗器械更智能，也更联网。这带来新机会，也带来新挑战，重点是数据安全和隐私保护

[13]

。监管方需要不断更新法规，要跟上新技术，也要保证患者安全和数据保护。比如，远程医疗和移动医疗设备的监管框架在逐步建立，目的是在带来便利的同时满足严格的安全和性能标准。监管方也在探索怎么用大数据和人工智能，提高监管效率和质量

[5, 7, 9]

。

2.2．质量与风险管理

高质量不是写出来的，而是跑出来的。YY/T 0316（等同 ISO 14971）给出从危害识别到残余风险评价的全流程方法；YY/T 0664（等同 IEC 62304）规定软件生命周期、回归验证与问题解决；GB 9706 系列构筑电气安全与基本性能底座；GB/T 16886（ISO 10993）指导材料与生物学评价；GCP 保障临床试验的科学性与伦理合规

[5-8, 16]

。企业应以可追溯矩阵把 URS-SRS-设计输出-验证/确认-临床评价-上市后证据串接起来，让每一次需求变更都触发风险再评估、网络安全复核与使用者界面复核。与其在出厂前“突击补文档”，不如把质量做进迭代节拍：周会看板同步 DHF/DMR 完整度，版本冻结即准备型式检验与第三方检测，量产转移前完成 IQ/OQ/PQ 与 KPP 稳定性监测。如此，质量体系不再是“合规成本中心”，而会成为协作与审评沟通的“加速器”

[3-7]

。

表1 中国市场分级-注册-证据-商业。

适用范围/产品类型	风险分级与注册路径	证据与资料要点	检测/标准要点	商业与支付要点
常规低风险器械（如基本监护附件）	Ⅰ类备案；地市与县域优先布局	基本安全与性能证明、风险管理文件、使用说明；上市后监测计划	GB 9706 通用要求、EMC/电气安全基础测试；生物相容性按需	院内小额采购为主；以维护响应与培训简易性驱动放量
中等风险通用设备（如通用监护、影像辅件）	Ⅱ类注册；可申请优先审批（符合条件）	同品种对比为主+必要临床评价；可用性工程与网络安全自评；DHF/DMR 完整性	GB 9706 系列+EMC；软件按 YY/T 0664；互联互通接口文档	省级/联盟集中招采，重视售后SLA；与 DRG/DIP 相关流程效率指标便于准入
高风险介入/生命支持类	Ⅲ类注册；可申报创新特别审查或优先审批	前瞻性临床试验为主；GCP、伦理批件、统计分析计划；HTA 初步证据与经济学模型	型式检验全套；材料/生物学评价（GB/T 16886）；风险管理（YY/T 0316）	高值耗材带量采购敏感；需以临床结局与并发症降低证据支撑价格与准入
SaMD/含软件器械（诊断/决策支持）	Ⅱ/Ⅲ类视风险注册；算法变更按变更控制	性能验证、可解释性说明、网络安全与数据治理、人因/可用性；版本与数据台账	YY/T 0664 软件生命周期；安全/隐私与接口测试；必要时开展临床评价	设备+服务+数据+合同；探索结果导向合同与分阶段付款
真实世界证据（RWE）先行（如海南乐城）	依规开展RWD/RWE研究用于临床评价补充与适应证扩展	RWE方案、数据质量与偏移控制；伦理与隐私合规	与注册技术审评要点保持一致的数据模型和指标定义	率先进入试点医院，回流全国注册与院内准入/医保谈判证据
UDI 与追溯/上市后监管	UDI 分批实施；不良事件、再评价、CAPA 闭环	PMS/PMCF 方案、召回与纠正预防流程	追溯平台对接与批次管理	招采与回款更依赖可追溯合规；提升渠道与医院信任
院内准入与互联互通	依据医院管理办法/技术评审流程办理	临床评价报告、型检报告、网络安全自评、接口与数据说明、人因报告	互联互通测评要求（HIS/LIS/PACS 对接）	以培训、维护、运维看板降低采用阻力；KOL 示范推动多院复制
招采与支付（DRG/DIP）	省级/联盟集中带量采购与医院采购并行	经济学证据、可比价策略与服务打包方案	——	价格中枢下探；以服务化/按结果付费维持毛利与现金流

3．创新管理框架

3.1．需求导向与中国场景画像

中国市场的“多层级、多场景”特征鲜明：省级三甲追求稳健性能与顺滑互联，地市主力医院强调易学易用与维护快捷，县域与基层更在意一次性成本与培训时长。需求挖掘应做田野化观察，贴身记录不同工况下的任务拆解，抓住隐性成本。据此构建病种-任务-约束-替代方案-付费意愿的结构化样式，并绘制机会-证据热力图，形成优先级共识

[9-12]

。

3.2．阶段闸门与组合优化

闸门治理强调及时止损与快速加码。1：完成标准适用性清单、风险初评、临床方案草案与网络安全威胁建模；2：冻结关键指标，完成可用性工程与第三方检测路线；3：产出型式检验/临床批件或充分的同品种对比；4：完成DHF/DMR、工艺验证与UDI上线；5：建立不良事件-CAPA-再评价闭环与RWE项目

[12-15]

。

资本配置上，以NPV/rNPV衡量单项目价值，以组合优化在多项目间分配工程能力与外部审评窗口，协方差需反映共享资源瓶颈与政策事件共振。为避免“文档化”的度量偏差，引入TRI与ESI的综合价值得分，并以“价值得分/资源消耗”驱动转向或停跳。

NPV = \ sum_{t =0}^{T} CF_t / (1+ r)^t

(1)

rNPV = \ sum_{t =0}^{T} (p_t_? CF_t) / (1+ r)^t

(2)

3.3．中国式“证据-商业”

商业证据如何转化为支付与采用的能力：院内准入强调安全、有效、可维护与互联互通；集中带量采购重同质化与服务能力

[17, 19]

；DRG/DIP 以病组成本权重与结余机制影响医院决策。建议把结局与流程指标写进SAP与RWE方案，明确统计口径、随访周期与联动业务条款，使价值叙事-证据生成-合同兑现形成闭环。

3.4．数字医疗与 SaMD

SaMD/含软件器械的本质是算法可控、数据可证、版本可追。需建立数据与模型台账、网络安全基线、互联互通适配与人因/可用性验证。在试点医院采用结果导向合同，以可观察的临床/流程改进作为结算锚点；善用先行区 RWD/RWE 将上市后数据回流注册扩展与指南共识，形成正反馈回路

[5-7, 12, 18]

。

4．国内案例与模拟

案例：便携式血流动力学监测器

围术期与ICU的容量管理属于时间敏感、风险敏感、信息稀疏的决策问题：传统有创方案对经验依赖高且伪迹频发；地市与县域存在培训与维护资源不足。目标产品为连续、无创的血流动力学监测，首适应证聚焦容量反应性判定与灌注优化。

合规与工程：按目录定位为Ⅱ/Ⅲ类，采用同品种对比+必要前瞻性临床；G1-G2完成可用性工程与网络安全威胁建模，固化接口标准与互联互通；设计输入同步落实报警管理与人因风险控制，减少报警疲劳。

证据路径：①方法学对照；②多中心可用性/工作流评估；③上市后RWE，将设备输出与住院天数、并发症率、ICU转入率、关键用药/用材量等指标关联，为院内准入与集采谈判提供成本-效果支撑

[2, 6, 10-12]

。商业模式：省会三甲示范“设备+培训+维保+指标看板”，地市/县域采用托管运维与分阶段付款，联动DRG/DIP统一口径。上市后治理：建立IQ/OQ/PQ与KPP监控，UDI追溯对接，构建不良事件-CAPA-再评价闭环与RWE回流注册机制

[13]

。

表2 关键里程碑-证据-资本计划。

里程碑	关键证据	监管/合规输出	资本需求（万元）	预期增值 ΔV_k
概念验证	台架/动物一致性数据	技术沟通要点	¥576	中
设计冻结	可用性验证、网络安全测试	DHF/DMR 完整度	¥1080	中高
临床评价	前瞻性对照/等同性论证	注册技术审评要点与型检报告	¥2160	高
量产转移	过程验证、上市后计划	QMS 审核/发证、UDI上线	¥1440	中
市场扩张	RWE与经济学研究	院内准入/集采/医保谈判材料	¥1800	高

5．中国情境下的实施清单

（1）把合规做成能力：以“标准适用性清单 + 追溯矩阵”为节拍器，需求变更即触发风险再评估与网络安全复核，版本冻结即准备第三方检测与型式检验。

（2）把证据写进商业：在 SAP/RWE 方案中明确“院内准入/DRG-DIP相关指标”的口径、随访与阈值，把可观测的改进转化为可兑现的合同。

（3）善用政策工具：原创性项目申请创新特别审查/优先审批；适宜病种用好先行区 RWD/RWE；在集采中以服务化与可追溯增强竞争力。

（4）工程化质量与上市后治理：DHF/DMR 电子化、UDI 与 PMS/PMCF 看板在线化，构建“信号发现-根因分析-CAPA 实施-再评价”闭环。

（5）平台化协作：以“省会三甲-地市骨干-县域协同”构建验证网络，联合第三方检测、注册代理、CRO、数据治理与安全合规伙伴。

（6）资本与节拍：融资额度对齐“从当前闸门到下一闸门”的净现金需求，以里程碑价值增量作为触发器，避免过量资金导致节拍失真。

（7）组织与文化：建立“闸门会议+数据看板”机制，鼓励“逆向证据”进入讨论，避免确认性偏差；沉淀安全-有效-成本效益的跨部门共识。

6．讨论与政策启示

监管：在重点专科探索监管力度与并行审评/技术指导常态化，让审评科学家与工程团队在“临床可达性”与“工程可实现性”之间找到平衡；对 SaMD/AI 形成变更控制与上市后性能承诺模板，允许在既定“性能守则”内进行快速小步迭代，以真实世界数据持续校准

[2, 5-7, 18]

。

支付：在 DRG/DIP 框架下推动过程与结局改进的量化，鼓励结果导向合同与分阶段支付激励临床采用，并逐步建立跨省可比的“指标词典”，减少多地沟通成本

[10, 12]

。

医院：建议将 HTA/准入—采购—绩效串联为一体化机制，把互联互通、维护 SLA、培训工时、报警管理、数据安全责任等“隐性成本”显性化、可计量化，以“全成本”决策

[9, 14]

。

产业与资本：以闸门+看板提升透明度，以外部能力地图划定自建/合作/外包边界；在“集采-服务化-金融工具”三角中寻找现金流弹性最优点，让“好证据”快速转化为“好回款”。

7．结论

在中国语境下，合规即设计不是“合规压创新”，而是把法规-质量-证据-商业四线合一、彼此成就的工程化方法。只要把阶段闸门的门槛做实、把 rNPV + 组合优化的权重算清、把 RWE + 结果导向合同的通道打通，再以 UDI + PMS/PMCF 的追溯与治理托底，医疗器械创新就能在国内的监管与支付轨道上跑得又快又稳。后续研究可围绕不同省域与医院层级构建场景化参数库，探索数据安全与算法治理的行业通用做法，以进一步降低转化摩擦、提升系统效率与公平可及。

ORCID

0009-0006-4069-2779（张楷文）

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APA Style

Kaiwen, Z. (2025). Managing Medical Device Industry Innovation and Entrepreneurship in China. Science Innovation, 13(6), 190-193. https://doi.org/10.11648/j.si.20251306.19

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ACS Style

Kaiwen, Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci. Innov. 2025, 13(6), 190-193. doi: 10.11648/j.si.20251306.19

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AMA Style

Kaiwen Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci Innov. 2025;13(6):190-193. doi: 10.11648/j.si.20251306.19

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@article{10.11648/j.si.20251306.19,
  author = {Zhang Kaiwen},
  title = {Managing Medical Device Industry Innovation and Entrepreneurship in China
},
  journal = {Science Innovation},
  volume = {13},
  number = {6},
  pages = {190-193},
  doi = {10.11648/j.si.20251306.19},
  url = {https://doi.org/10.11648/j.si.20251306.19},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.si.20251306.19},
  abstract = {Focusing on mainland China, this paper builds an integrated framework for medical device innovation management and entrepreneurship aligned with NMPA/CMDE practice, DRG/DIP payment reforms, and volume-based procurement. We translate compliance requirements—such as device classification, clinical evaluation protocols, quality and risk management systems (including standards like YY/T 0316, YY/T 0664, and GB 9706), unique device identification (UDI), and post-market surveillance—into a comprehensive compliance-by-design operating model that emphasizes proactive risk mitigation and regulatory adherence. This framework incorporates stage-gate governance processes to manage development milestones, risk-adjusted valuation methods to assess financial viability, and portfolio optimization strategies to prioritize high-impact projects. Additionally, we align evidence generation with business objectives to facilitate hospital entry and tendering processes, ensuring that clinical data supports market access and reimbursement decisions. A detailed China-specific case study of a portable hemodynamic monitor illustrates how early engagement with regulatory bodies for scientific advice, real-world pilot studies, and results-based contracting can significantly enhance expected value projections and reduce time-to-access for patients. The paper concludes by exploring policy options to foster innovation, including the establishment of software as a medical device (SaMD) and artificial intelligence (AI) sandboxes for testing, broader acceptance of real-world evidence (RWE) in regulatory decisions, and health technology assessment (HTA) capacity building to support evidence-informed policymaking and sustainable healthcare innovation.
},
 year = {2025}
}

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TY  - JOUR
T1  - Managing Medical Device Industry Innovation and Entrepreneurship in China

AU  - Zhang Kaiwen
Y1  - 2025/12/24
PY  - 2025
N1  - https://doi.org/10.11648/j.si.20251306.19
DO  - 10.11648/j.si.20251306.19
T2  - Science Innovation
JF  - Science Innovation
JO  - Science Innovation
SP  - 190
EP  - 193
PB  - Science Publishing Group
SN  - 2328-787X
UR  - https://doi.org/10.11648/j.si.20251306.19
AB  - Focusing on mainland China, this paper builds an integrated framework for medical device innovation management and entrepreneurship aligned with NMPA/CMDE practice, DRG/DIP payment reforms, and volume-based procurement. We translate compliance requirements—such as device classification, clinical evaluation protocols, quality and risk management systems (including standards like YY/T 0316, YY/T 0664, and GB 9706), unique device identification (UDI), and post-market surveillance—into a comprehensive compliance-by-design operating model that emphasizes proactive risk mitigation and regulatory adherence. This framework incorporates stage-gate governance processes to manage development milestones, risk-adjusted valuation methods to assess financial viability, and portfolio optimization strategies to prioritize high-impact projects. Additionally, we align evidence generation with business objectives to facilitate hospital entry and tendering processes, ensuring that clinical data supports market access and reimbursement decisions. A detailed China-specific case study of a portable hemodynamic monitor illustrates how early engagement with regulatory bodies for scientific advice, real-world pilot studies, and results-based contracting can significantly enhance expected value projections and reduce time-to-access for patients. The paper concludes by exploring policy options to foster innovation, including the establishment of software as a medical device (SaMD) and artificial intelligence (AI) sandboxes for testing, broader acceptance of real-world evidence (RWE) in regulatory decisions, and health technology assessment (HTA) capacity building to support evidence-informed policymaking and sustainable healthcare innovation.

VL  - 13
IS  - 6
ER  -

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Author Information

Zhang Kaiwen

School of Management, University of Shanghai for Science and Technology, Shanghai, China

Contact Email

http://orcid.org/0009-0006-4069-2779

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Table 1

表1 中国市场分级-注册-证据-商业。
Table 2

表2 关键里程碑-证据-资本计划。

Plain Text BibTeX RIS

APA Style

Kaiwen, Z. (2025). Managing Medical Device Industry Innovation and Entrepreneurship in China. Science Innovation, 13(6), 190-193. https://doi.org/10.11648/j.si.20251306.19

Copy | Download

ACS Style

Kaiwen, Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci. Innov. 2025, 13(6), 190-193. doi: 10.11648/j.si.20251306.19

Copy | Download

AMA Style

Kaiwen Z. Managing Medical Device Industry Innovation and Entrepreneurship in China. Sci Innov. 2025;13(6):190-193. doi: 10.11648/j.si.20251306.19

Copy | Download

@article{10.11648/j.si.20251306.19,
  author = {Zhang Kaiwen},
  title = {Managing Medical Device Industry Innovation and Entrepreneurship in China
},
  journal = {Science Innovation},
  volume = {13},
  number = {6},
  pages = {190-193},
  doi = {10.11648/j.si.20251306.19},
  url = {https://doi.org/10.11648/j.si.20251306.19},
  eprint = {https://article.sciencepublishinggroup.com/pdf/10.11648.j.si.20251306.19},
  abstract = {Focusing on mainland China, this paper builds an integrated framework for medical device innovation management and entrepreneurship aligned with NMPA/CMDE practice, DRG/DIP payment reforms, and volume-based procurement. We translate compliance requirements—such as device classification, clinical evaluation protocols, quality and risk management systems (including standards like YY/T 0316, YY/T 0664, and GB 9706), unique device identification (UDI), and post-market surveillance—into a comprehensive compliance-by-design operating model that emphasizes proactive risk mitigation and regulatory adherence. This framework incorporates stage-gate governance processes to manage development milestones, risk-adjusted valuation methods to assess financial viability, and portfolio optimization strategies to prioritize high-impact projects. Additionally, we align evidence generation with business objectives to facilitate hospital entry and tendering processes, ensuring that clinical data supports market access and reimbursement decisions. A detailed China-specific case study of a portable hemodynamic monitor illustrates how early engagement with regulatory bodies for scientific advice, real-world pilot studies, and results-based contracting can significantly enhance expected value projections and reduce time-to-access for patients. The paper concludes by exploring policy options to foster innovation, including the establishment of software as a medical device (SaMD) and artificial intelligence (AI) sandboxes for testing, broader acceptance of real-world evidence (RWE) in regulatory decisions, and health technology assessment (HTA) capacity building to support evidence-informed policymaking and sustainable healthcare innovation.
},
 year = {2025}
}

Copy | Download

TY  - JOUR
T1  - Managing Medical Device Industry Innovation and Entrepreneurship in China

AU  - Zhang Kaiwen
Y1  - 2025/12/24
PY  - 2025
N1  - https://doi.org/10.11648/j.si.20251306.19
DO  - 10.11648/j.si.20251306.19
T2  - Science Innovation
JF  - Science Innovation
JO  - Science Innovation
SP  - 190
EP  - 193
PB  - Science Publishing Group
SN  - 2328-787X
UR  - https://doi.org/10.11648/j.si.20251306.19
AB  - Focusing on mainland China, this paper builds an integrated framework for medical device innovation management and entrepreneurship aligned with NMPA/CMDE practice, DRG/DIP payment reforms, and volume-based procurement. We translate compliance requirements—such as device classification, clinical evaluation protocols, quality and risk management systems (including standards like YY/T 0316, YY/T 0664, and GB 9706), unique device identification (UDI), and post-market surveillance—into a comprehensive compliance-by-design operating model that emphasizes proactive risk mitigation and regulatory adherence. This framework incorporates stage-gate governance processes to manage development milestones, risk-adjusted valuation methods to assess financial viability, and portfolio optimization strategies to prioritize high-impact projects. Additionally, we align evidence generation with business objectives to facilitate hospital entry and tendering processes, ensuring that clinical data supports market access and reimbursement decisions. A detailed China-specific case study of a portable hemodynamic monitor illustrates how early engagement with regulatory bodies for scientific advice, real-world pilot studies, and results-based contracting can significantly enhance expected value projections and reduce time-to-access for patients. The paper concludes by exploring policy options to foster innovation, including the establishment of software as a medical device (SaMD) and artificial intelligence (AI) sandboxes for testing, broader acceptance of real-world evidence (RWE) in regulatory decisions, and health technology assessment (HTA) capacity building to support evidence-informed policymaking and sustainable healthcare innovation.

VL  - 13
IS  - 6
ER  -

Copy | Download