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What is medical device

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[img]What is Medical Device

A medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease; or
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury; or
  • investigation, replacement, modification, or support of the anatomy or of a physiological process; or
  • supporting or sustaining life; or
  • control of conception; or
  • disinfection of medical devices; or
  • providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;

and which does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but which may be assisted in its intended function by such means.

"Source: Harmonized definition of the term "medical device", Section 5, Proposed Document SG1/N029R13, Global Harmonization Task Force, March 26, 2003"

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Last Revision Date : 15 December 2012