Monthly Archives: March 2022

Trade of medical devices for human use

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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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Operational leasing

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The institute of business or operational leasing is not prescribed in the positive regulations of the Republic of Serbia. In the business practice of economic entities, the term operational leasing is used, which means the lease of movable and immovable property, i.e. sale with instalment payments of the price for the purchased item, which is precisely regulated by the provisions of Art. 567 to 599 (lease of property) or Art. 542 to 551 (sale with instalment payments of the price) of the Law on Obligations “Official Gazette of the SFRY”, No. 29/78, 39/85, 45/89 – decision of the USJ and 57/89, “Official Gazette of the FRY” “, No. 31/93,” Official Gazette of Serbia and Montenegro “, No. 1/2003 – Constitutional Charter and” Official Gazette of RS “, No. 18/2020).

Operating leasing activities may be performed by companies in the field of production (equipment), i.e. companies in the trade area as an ancillary activity within their core production business, i.e. trade.

Operating leasing activities are not within the competence of the National Bank of Serbia and are not subject to the obligation to provide share capital from Article 10a of the Law on Financial Leasing (“Official Gazette of RS”, No. 55/2003, 61/2005, 31/2011 and 99/2011 – dr. laws) (from now on: the Law on Financial Leasing). Continue reading Operational leasing →