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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Pharmacy institution

Organizing and performing pharmacy activities in the Republic of Serbia is performed following the Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019), the law governing health insurance, the law governing drugs and the law governing medical devices, as well as the Guide to Good Pharmacy Practice, issued by the Pharmaceutical Chamber of Serbia, with the consent of the Minister.

The Law on Health Care Protection (“Official Gazette of RS”, No. 25/2019), among other things, regulates the concept of pharmacy activity, activities that include pharmacy activity, as well as forms of organization that shall perform pharmacy activity.

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Types, Requirements for Setting up and Termination of Work of Private Practice

According to provisions of Law on Health Care (“Official Gazette of the Republic of Serbia”, No. 25/2019) providers of health care are:

  • institutions of higher education of health professionals and other legal entities for which a special law stipulates that perform the tasks of health services
  • private practice
  • health care practioners who perform health activity, in accordance with the law
  • other higher education institutions and scientific-educational and scientific institutions, with the opinion of the Ministry of Health, in accordance with the law.

Requirements for Setting up of Private Practice

Private practice may be set up by: