Quality and safety regulations
Regulation 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.
Dr Katrina Ignacio at the Philippine General Hospital in Manila, Philippines on 26 March 2021. She is among the first Filipinos to be vaccinated against COVID-19 in the country, after working at the frontline of the pandemic over the last year.
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”.
WHO develops training materials with professional organizations to assist national regulatory agencies with staffing of qualified biomedical engineers, technicians and regulatory professionals, to perform evaluation, registration, premarket approval and post-market surveillance activities for medical devices.
More information on regulation of medical devices and other health products
67th World Health Assembly Resolution
WHA67.20 “Regulatory system strengthening for medical products”
The 67th WHA approved the resolution “Regulatory system strengthening for medical products." It states the importance of regulations for medical devices as one of the medical products, for better public health outcome and to increase access to safe, effective and quality medical products. The complete text of the Resolution, in the 6 WHO official languages are available.
Arabic │Chinese │ English │ French │ Russian │ Spanish
Statistics
Regulatory systems for medical devices are less developed than those for other health products such as medicines or vaccines. According to desk survey performed in 2015-2016, 58% of WHO member states have a regulation for medical devices in place, no matter how limited. WHO has a clear role and mandate in building regulatory capacity through training and harmonization and is committed to this important work, with the support of all stakeholders.
Publications
WHO Global Model Regulatory Framework for Medical Devices including in vitro diagnostic...
Global Collaboration for medical device regulation
Collaboration is at the heart of all we do. Every day we connect nations, partners and experts so that we can go further, together. Our partners help support WHO’s scientific work and field programmes, contribute funding and resources, engage in our campaigns and programmes and join us in advocacy to bring policy and behaviour change for better health. Official collaborations with WHO are conducted in the following forms:
Asian Harmonization Working Party (AHWP)
WHO also recognizes other regional organizations as “Asian Harmonization Working Party” (AHWP).
International Medical Devices Regulators Forum (IMDRF)
WHO is an official observer in the management committee of the “International Medical Devices Regulators Forum” (IMDRF).