This white paper proposes a comprehensive value-based framework for assessing medical devices within Malaysia’s healthcare system. It highlights limitations of traditional assessment methods that fail to capture innovation, patient-centered outcomes, and long-term system value. Through case studies, the paper demonstrates how devices improve efficiency, access, and outcomes beyond direct clinical endpoints. It recommends expanding evidence generation, strengthening stakeholder engagement, aligning regulatory and economic policies, and building assessment capacity. The paper concludes that modernized value assessment is essential to ensure equitable access to innovative medical technologies and sustainable healthcare investment.

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