艾昆纬-加强马来西亚医疗器械的评估_一种基于价值的综合方法（英）-2025_45页_3mb

医疗设备价值评估实践在马来西亚的发展

医疗技术协会(MaHTAS)在马来西亚国家医疗系统的框架下，主要通过健康技术评估(HTA)对医疗技术进行评估，包括审查安全性、有效性、成本与使用组织影响等多个维度。

关键发现

1. 评估方法：风险分类机制区分认定医疗器械，不同等级需经不同严格评估程序。
2. 需求交错点：评估方法在设备领域表现出局限性，经济评估方法更适合药品而非估值更复杂、多维的医疗设备。
3. 挑战：缺乏标准数据收集机制；行业与监管路径割裂。
4. 推荐措施：建立自上而下的评估框架；利用真实世界数据；提升人工训练效率；国家医疗政策水平匹配。

路径图与推荐措施

1. 构建综合评估框架：根据马来西亚医疗环境，定义适应性良好的评估维度，需纳入患者体验与社会影响。
2. 数据生态建设：鼓励设备制造商参与真实世界研究，建设透明数据共享机制。
3. 人才储备与合作：提升医疗系统人员训练，与国际组织合作开发技能课程，建立医疗设备议价能力。
4. 政策协调与财政机制：将HTA与采购流程无缝衔接，调整报销政策，优化设备采用整合机制。

现状与未来展望

马来西亚正努力通过标准化医疗设备价值评估提高系统整体效能。近期发展的重点是加强透明性与患者视角，为循证临床创新打下基础。
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Summary

The Medical Device Authority (MDA) oversees the safety, quality and performance benchmarks for medical devices in Malaysia. The broader value evaluation is conducted through Health Technology Assessment (HTA) on demand by relevant stakeholders. MaHTAS focuses on clinical effectiveness, cost-effectiveness and organizational implications of medical technologies.

Key findings: The HTA framework has robust methodologies, but faces challenges. Data scarcity for new technologies hampers comprehensive evaluation, and device characteristics like learning curve effects complicate assessment. Current economic evaluation focuses on cost-effectiveness, which may not fully capture device impacts in healthcare settings.

Recommendations to enhance device value assessment: establish a multidimensional evaluation framework adapted to the local context; enhance the generation and validation of real-world evidence and data collection; improve transparency and foster inclusive stakeholder dialogue; pilot frameworks before broad implementation and monitor progress.

Implementation challenges: standardize evaluation criteria, strengthen administrative capacity, improve healthcare infrastructure, and advance research collaboration networks to support market adoption of proven technologies.