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Medical Devices Regulation in European

The regulation of medical devices is primarily concerned with enabling patient access to high quality, safe and effective medical devices, and avoiding access to products that are unsafe. When appropriately implemented, regulation ensures public health benefit and the safety of patients, health care workers and the community. WHO has a mandate, as outlined in the World Health Assembly (WHA) Resolution 60.29 “to encourage member states to draw up national or regional guidelines for good manufacturing and regulatory practices, to establish surveillance systems and other measures to ensure the quality, safety and efficacy of medical devices and, where appropriate, to participate in international harmonization.”  

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ACF GHS Report