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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WHO compendium of innovative health technologies for low resource settings, 2011-2014

This is a continuation of the compendium series of innovative medical devices, assistive devices and eHealth solutions, inclusive of 2011-2014. The objective...

Compendium of innovative health technologies for low-resource settings

The objective of the compendium series of innovative medical devices, assistive devices and eHealth solutions is to provide a neutral platform for technologies...

Medical devices and eHealth solutions: compendium of innovative health technologies for low-resource settings 2011-2012

The compendium series of innovative medical devices and eHealth solutions has been created as a neutral platform for technologies which are likely to...

Compendium of new and emerging health technologies

The compendium of new and emerging technologies that address global health concerns has been created as a neutral platform for technologies which are...

Innovative Technologies that Address Global health Concerns

The overall goal of the initiative is to help address important health problems associated with communities in resource-limited settings by making available...