Quality and safety regulations
Medical devices need to be of adequate quality and safety to bring public health benefits without harming patients, health care workers or the community. Thus, regulations mandate that all devices, whether imported or locally produced, meet international norms and standards.
World Health Assembly resolution 60.29 urges 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 participate in international harmonization. Furthermore, WHO's Strategic Objective 11 states that it is necessary to ensure improved access, quality and use of medical products and technologies
WHO promotes the work done by the Global Harmonization Task Force and the Asian Harmonization Working Party to harmonize regulation practices and it also encourages that national regulatory agencies have biomedical engineers, or similar specialized professionals, to perform the evaluation, registration, premarket approval and postmarket surveillance process of medical devices.
WHO provides guidance on the topic of medical device regulations and will soon be producing reference documents on premarket approval and post-market surveillance.
65% of 145 countries have an authority responsible for implementing and enforcing medical device specific product regulations.
