Health products policy and standards
Our team provides authoritative guidance and standards on quality, safety and efficacy of health products and supports countries to formulate evidence-based policies and ensure good practice throughout the value chain.

Access to Health Products Policy

The 2030 Agenda for Sustainable Development places health, well-being and universal health coverage at the centre of its development vision, with the commitment to leave no one behind. Universal health coverage includes appropriate access to affordable and quality-assured medicines and health products. As essential health products, assistive products and medical devices (including in vitro diagnostics) are fundamental to the achievement of good health and well-being, universal health coverage, and for preparedness and response to emergencies and outbreaks.

WHO’s unit of Assistive Technology and Medical Devices sits within the Health Products Policies and Standards Department of the Access to Medicines and Health Products Division. This unit supports Member States to improve access to assistive products and medical devices, including in vitro diagnostics, personal protective equipment (PPE), medical imaging and implantable technologies. The wide spectrum of the work of the unit encompasses: development of policy guidance; selection of priority and essential products as reference for development or update of national lists;  technical specifications for procurement; information on training, safe use, maintenance and decommissioning; and finally new and innovative technologies.

Since early 2020, the WHO’s unit of Assistive Technology and Medical Devices has also played an important role in the COVID-19 response for IVDs, oxygen products, PPEs, and other technologies critical for the diagnosis and treatment of COVID-19. 

 

Our work

Assistive technology publications

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Accelerating access to assistive technology: Eastern Mediterranean Regional workshop report, Cairo, Egypt, 3-5 December 2024

From 3 to 5 December 2024, the World Health Organization (WHO), in collaboration with the United Nations Children’s Fund (UNICEF), convened a regional...

Accelerating access to assistive technology: report on multi-country workshop, Rio de Janeiro, Brazil, 5-7 December 2023

In the Region of the Americas, with more than one billion people, and a mix of low, middle, and high-income economies, the availability, quality, and provision...

Multi-country rapid assistive technology assessment (‎rATA)‎ 2019-2021: findings from a consultative review

This report documents a consultative review of the rapid Assistive Technology Assessment (rATA) survey and implementation. The review was carried out to...

Essential medicines publications

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The selection and use of essential medicines, 2025: WHO AWaRe (Access, Watch, Reserve) classification of antibiotics for evaluation and monitoring of use

he AWaRe classification is intended as a tool for monitoring antibiotic consumption, defining targets and monitoring the effects of stewardship policies...

The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines for Children, 10th list

Essential medicines are those that satisfy the priority health care needs of a population. They are selected with due regard to disease prevalence and...

The selection and use of essential medicines, 2025: WHO Model List of Essential Medicines, 24th list

Essential medicines are those that satisfy the priority health care needs of a population. They are selected with due regard to disease prevalence and...

The selection and use of essential medicines, 2025: report of the 25th WHO Expert Committee on Selection and Use of Essential Medicines, executive summary

This executive summary reports the recommendations made by the Expert Committee on Selection and Use of Essential Medicines for the 2025 update of the...

In vitro diagnostics publications

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The selection and use of essential in vitro diagnostics: report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (‎including the fourth WHO model list of essential in vitro diagnostics)‎

The Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model...

Target product profile for readers of rapid diagnostic tests

Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including...

Selection of essential in vitro diagnostics at country level: using the WHO Model List of Essential In Vitro Diagnostics to develop and update a national list of essential in vitro diagnostics

This document intends to provide guidance to countries on methods for developing and updating national lists of essential in vitro diagnostics (NEDL)....

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics

Post-market surveillance is a set of activities conducted by manufacturers, to collect and evaluate experience gained from medical devices that have...

Medical devices publications

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Inventory and maintenance management information system for medical device

Health-care technology has played a fundamental role in medicine for centuries, evolving with scientific advances to improve patient diagnosis, treatment...

Health technology assessment of medical devices, 2nd ed

HTA is a multidisciplinary process used to evaluate the clinical, economic, ethical implications and social impact of new health technologies. This...

Medical device donations: considerations for solicitation and provision. Second edition

Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical...

WHO compendium of innovative health technologies for low-resource settings 2024

Access to appropriate, affordable, effective, and safe health technologies is paramount, especially in low-resource settings, where burden of  non-communicable...

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Digital Health and Innovation
Digital technologies are now integral to daily life, and the world's population has never been more interconnected. Innovation, particularly in the digital health sphere, is also happening on an unprecedented scale. Despite this, the potential of digital technologies and innovation to improve the health of populations remains largely untapped. With a coordinated approach to health products and systems innovation, there is an immense opportunity to expand their use, especially in low- and middle-income countries. WHO is harnessing the power of digital technologies and health innovation to accelerate global attainment of health and the well-being.