Medical devices

DEFINITIONS

Health technology:

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’.

Medical device (brief):

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

Medical equipment:

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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