AT the 60th World Health Assembly (WHA) in 2007, Resolution 60.29 urged 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 harmonisation”.
Following up, the 67th WHA (2014) approved the resolution “Regulatory system strengthening for medical products”, which stresses the importance of regulations for medical devices for better public health outcome and to increase access to safe, effective and quality medical products.