Development of Medical Device Policies. 2011. (WHO Medical Device Technical Series)
(2011; 45 pages) [Chinese] [French] [Greek] [Spanish]


When used within the context of a robust health system, medical devices improve health outcomes. Through such a system, medical devices can be effectively allocated based on the needs of a particular population. A health system, however, is only as good as the polices, strategies, and action plans that constitute it.

The World Health Organization (WHO) and its Member States recognized this in several World Health Assembly resolutions highlighting the importance of health technologies, particularly medical devices, to prevent, diagnose, treat illness, disease, and disability, and improve health and quality of life. Member States were urged to formulate appropriate national strategies and plans for assessment and management of medical devices; and WHO was requested to provide technical guidance to Member States in implementing policies on health technologies.

Policies create a framework through which to direct valuable resources. A national health policy framework includes a vision, a situation analysis, policy directions, strategies to overcome challenges, a policy implementation plan, and the leadership and governance required to achieve sustainability. When embedded within a national health policy, health technologies policies can be linked to other health systems components - financing, human resources, information, leadership and governance - that together address the needs of the target population and may result in better health outcomes.

Effective health technology policies address inequity as well as accessibility, affordability and availability of innovative and core medical devices required to target the health needs, particularly those that address the Millennium Development Goals and noncommunicable diseases. To do this the four phases of medical devices - research and innovation, regulation for device safety, assessment for better decision making, and comprehensive management - must be considered and adapted to the priority public health conditions, resources and settings.

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