2016 WHO Global Model Regulatory Framework for medical devices including IVDs.
WHO initiated the development of the WHO Global Model Regulatory Framework for Medical Devices including IVDs (the Model) to support its Member States in ensuring the quality and safety of medical devices.
Based on Resolution WHA 67.20 ‘Regulatory Systems Strengthening for Medical Products’ adopted by the World Health Assembly in 2014, WHO has undertaken a series of activities to scale up and strengthen regulatory capacities worldwide.
The draft of the Model is now open for second public consultation. We cordially invite you to provide comments.
Please follow the link below for the text of the Model, the form to insert your comments and the timetable for the development.
2016 Call for innovative health technologies for low-resource settings
Innovative technologies serve to fill existing gaps in the availability of health technologies to vulnerable populations through the provision of new solutions to health problems, the adaptation of existing technologies to a particular setting or for a new use, and the combination of technologies to address several health issues at once. WHO has been working, along with experts, collaborating centres and Member States, to raise awareness on innovative technologies.
To take the right action in order to fulfill WHO’s mandate in advancing the global health agenda in the field of health technologies, well-founded information is needed about the current status of availability of policies, guidelines, standards, and services for assessment, management and regulation in Member States. The results of the WHO Baseline Country Survey on Medical Devices update 2014 provide data from 177 countries on topics such as health technology policies, regulation, and innovation.
Due to the urgency of the Ebola outbreak and the WHO’s scale up of international response in west Africa, WHO is providing technical information on appropriate available essential medical devices which are indispensable for treatment centres, community-based units and other preventive activities, in affected and neighbouring countries.
The Second Global Forum, organized by the medical devices unit of WHO, will provide the global medical devices community with a forum to share best practices, challenges and updates on progress in assessment, development, management and regulations since the First Global Forum in Bangkok in 2010, where stakeholders from 107 countries participated. The Forum will also address the development of lists of medical devices by clinical intervention and disseminate information about innovative, appropriate, and affordable devices for low resource settings.
United Nations Commission on Life-saving Commodities
The United Nations Commission on Life-Saving Commodities for Women and Children aims to increase access to life-saving medicines and health supplies for the world’s most vulnerable people by championing efforts to reduce barriers that block access to essential health commodities. The commission has made 10 recommendations to increase access to 13 essential, overlooked commodities in four categories (reproductive health, maternal health, newborn health, and child health). WHO is fully responsible for recommendations 4 and 5 and participates in others as needed. The Medical Devices unit is specifically looking at strengthening the quality and improving the regulatory efficiency of three specific types of medical devices: the female , neonatal resuscitation equipment (mask, valve and bag), and for injectable antibiotics.
Medical Devices - Definitions
Medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation of illness and disease. The achievement of health-related development goals, including the Millennium Development Goals upon proper manufacturing, regulation, planning, assessment, acquisition, management and use of medical devices which are of good quality, safe and compatible with the settings in which they are used.
As outlined in the World Health Assembly resolution WHA60.29, the WHO Department of Essential Health Technologies (EHT), Diagnostics Imaging and Medical devices Team (DIM) aims to ensure improved access, quality and use of safe and appropriate medical devices in line with Primary .