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What is medical device
[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:
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