| |
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:
| (a) |
diagnosis, prevention, monitoring,
treatment or alleviation of disease; or |
| (b) |
diagnosis, monitoring, treatment,
alleviation of or compensation for an injury; or |
| (c) |
investigation, replacement, modification,
or support of the anatomy or of a physiological process; or |
| (d) |
supporting or sustaining life; or |
| (e) |
control of conception (including contraception);
or |
| (f) |
disinfection of medical devices; or |
| (g) |
providing information for medical 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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| Important notices
