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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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...

Technical specifications for pre-market assessment of medical masks

The purpose of this document is to provide technical specifications to medical mask manufacturers. The document is intended mainly for manufacturers but...

Sustainable management of radiotherapy facilities and equipment

Following adoption of resolutions WHA60.29 on health technologies and WHA70.12 (1,2) on cancer prevention and control, the World Health Organization...

Technical specifications for pre-market assessment of blood pressure measuring device with cuff, automated and semi-automated

The purpose of this document is to provide technical specifications for manufacturers of blood pressure measuring devices (BPMD). This document is intended...

Harmonized health facility assessment (‎HHFA)‎: comprehensive guide

The HHFA Comprehensive guide serves as the main reference document for planning and implementing a country HHFA. This guide will promote understanding...

Global atlas of medical devices 2022

The focus of the 2022 edition of the Global Atlas is to point out how the status of medical device topics supports or hinders the accomplishment of...

Human resources for medical devices, the role of biomedical engineers

Continuous developments in science and technology are increasing the availability of thousands of medical devices – all of which should be of good...

WHO compendium of innovative health technologies for low-resource settings 2022

The objective of the 2022 Compendium is to compile and highlight emerging innovative health technologies for low-resource settings. It presents a...

In the face of rapid increases in the number of hospitalizations due to COVID-19 in Latin America and the Caribbean, coupled with shortages of human and...

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...

Thumbanail for the PAHoblood pressure measuring devices publication

Cardiovascular disease (CVD) is the leading cause of disease burden globally. According to the 2017 Global Burden of Disease estimates, there were 14 million...