WHO Compendium of Innovative Health Technologies for Low-resource Settings (2011-2014) : assistive devices, eHealth solutions, medical devices, other technologies, technologies for outbreaks

The WHO Global Model Regulatory Framework for Medical Devices including in vitro Diagnostic Medical Devices (WHO IRIS 10665/202537) is a landmark policy guidance document published by the World Health Organization (WHO) to assist Member States—particularly low- and middle-income countries (LMICs)—in developing, updating, and enforcing effective national regulatory systems for medical technologies. Part of the WHO Medical Device Technical Series, this comprehensive model outlines a stepwise, progressive approach to regulatory oversight across the entire medical device life cycle, from pre-market approval and post-market surveillance to market control and adverse event reporting. The publication synthesizes internationally harmonized principles established by the Global Harmonization Task Force (GHTF) and the International Medical Device Regulators Forum (IMDRF), establishing standardized risk-based classification rules, conformity assessment procedures, and essential principles of safety and performance. By providing model legislative drafting concepts and operational guidelines for National Regulatory Authorities (NRAs), the framework seeks to prevent sub-standard, counterfeit, or unsafe medical devices and IVDs from entering healthcare markets while ensuring equitable access to high-quality health technologies. As an invaluable open educational resource, this technical guidance serves students, public health researchers, biomedical engineers, regulatory affairs officers, and health policy advisors studying international public health administration, global health governance, regulatory science, and health technology management.