Medical device refers directly or indirectly for any instrument, apparatus, appliance, in vitro diagnostic reagents and calibrators, materials, and other similar or related article, including the required computer software.

Effectiveness mainly by physics obtained, not by pharmacological, immunological or metabolic get in the way, or ways to participate but although these only play a supporting role.

Purpose is diagnosis, prevention, monitoring, treatment or mitigation; injury diagnosis, monitoring, treatment, mitigation or function compensation; physical structure or physiological process of inspection, replacement, adjustment or support; to support life or to maintain; pregnancy control; Based on a sample from the body for inspection, provide information for medical or diagnostic purposes.