What is a Medical Device?

Based on the regional and global definition of medical device, it is defined as:

Medical Device means any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article:

a)    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,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury
  • investigation, replacement, modification or support of the anatomy or of a physiological process,
  • supporting or sustaining life
  • control of conception
  • disinfection of medical devices
  • 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.

To explain further, medical devices are from a simple tongue depressor to a complicated MRI machine. Medical devices also included condoms, cottons, test tubes, etc. In-vitro diagnostic devices or self test tubes are also considered as medical devices.