Policies, strategies, and action plans for health technologies, specifically for medical devices, are required in any national health plan. Within the context of a robust health system, they ensure access to safe, effective, and high-quality medical devices that prevent, diagnose, and treat disease and injury, and assist patients in their rehabilitation.
WHO’s “Global Model Regulatory Framework for Medical Devices including in vitro diagnostic medical devices” supports Member States in developing and implementing regulatory controls and regional guidelines for good manufacturing to ensure the quality, safety, and efficacy of medical devices available in their countries. The Organization also works with Member States and collaborating centers to develop guidelines and tools, including norms and standards on medical devices.
Additionally, WHO supports Member States in establishing mechanisms to assess national needs for health technologies in particular medical devices and to assure their availability and use, particularly in low-resource settings. A web-based health technologies database serves as a clearing house and provides countries guidance on appropriate medical devices according to levels of care, setting, environment, and intended health intervention, tailored to the specific needs of country or region.
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