Is It a Medical Device?

Last Updated on February 22, 2022

The product is a medical device if it fulfils the following criteria:

Medical devices include any instrument, apparatus, implement, machine, appliance, implant, reagent for in-vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings or animals for one or more of the specific medical purposes of

  1. diagnosis, prevention, monitoring, treatment or alleviation of disease;
  2. diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
  3. investigation, replacement, modification or support of the anatomy or of a physiological process;
  4. supporting or sustaining life;
  5. control of conception;
  6. disinfection of medical devices; or
  7. providing information by means of in-vitro examination of specimens derived from the human body,

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