Trade of medical devices for human use

Trade in medical devices for human use (from now on: medical device) includes wholesale and retail sale of medical devices following the provisions of the Law on Medical Devices (“Official Gazette of RS”, No. 105/2017) and regulations adopted for its implementation.

Concept and classification of medical devices

Medical device (general) means any instrument, apparatus, appliance, software, implant, reagent, material and other product used alone or in combination, including software provided by the manufacturer for diagnostic or therapeutic purposes and which is software support necessary for its proper use in people intended by the manufacturer, and is used for:

  1. diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
  2. diagnosis, monitoring, treatment, alleviation or compensation of injury or disability
  3. investigation, replacement or modification of the anatomy or physiological or pathological process and state
  4. providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
  5. control or support of conception
  6. products intended for cleaning, disinfection or sterilization of medical devices.

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