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.

Medical devices

Definitions

What is health technology?

Health technology is the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of life.* It is used interchangeably with ‘health care technology’.

What are medical devices?

Brief definition: An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means.*

For the full definition as finalized by the Global Harmonization Task Force in May 2012 and now under the archives of the International Medical Device Regulators Forum, please follow link below.

Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic (IVD) Medical Device’, Global Harmonization Task Force, 2012

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What is medical equipment?

Medical equipment are defined as medical devices requiring calibration, maintenance, repair, user training and decommissioning – activities usually managed by clinical engineers.

Medical equipment is used for the specific purposes of diagnosis and treatment of disease or rehabilitation following disease or injury; it can be used either alone or in combination with any accessory, consumable or other piece of medical equipment. Medical equipment excludes implantable, disposable or single-use medical devices.
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WHO Medical Devices Technical Series

Publications on Medical Devices

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In the countries of the Region of the Americas, there are different forms of organization of health services at the first level of care. Some countries...

WHO list of priority medical devices for management of cardiovascular diseases and diabetes

This publication was developed in response to the need for a reference list of priority medical devices required for management of noncommunicable diseases...

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...

Priority medical devices list for the COVID-19 response and associated technical specifications

This document describes the medical devices required for the clinical management of COVID-19, selected and prioritized according to the...

Thumbnal for the COVID-19 priority medical devices by PAHO

This document updates PAHO's interim recommendations for case management of COVID-19 in health services. The list of priority medical devices in the context...

Guidance for procurement of in vitro diagnostics and related laboratory items and equipment

Testing programmes strive to procure products that are appropriate for the intended setting of use at the most reasonable price to ensure that testing...

diagnostic-images-what-is-it

Diagnostics imaging has developed rapidly to play a central role in medicines today.However, many countries in the  developing world cannot afford...