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:
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
- diagnosis, monitoring, treatment, alleviation or compensation of injury or disability
- investigation, replacement or modification of the anatomy or physiological or pathological process and state
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations
- control or support of conception
- products intended for cleaning, disinfection or sterilization of medical devices.
Continue reading Trade of medical devices for human use
The legal framework for regulating the conditions, manner and procedure of exemption from customs and other duties on the import of equipment, which is the investor’s role, is represented by the following regulations:
- Customs Law (“Official Gazette of RS”, No. 95/2018, 91/2019 – other law, 144/2020 and 118/2021)
- Law on Investments (“Official Gazette of RS”, No. 89/2015 and 95/2018) and
- Decree on the conditions, manner and procedure of exemption from customs and other duties on the import of equipment (“Official Gazette of RS”, No. 34/2019).
The provisions of Article 14 of the Law on Investments (“Official Gazette of RS”, No. 89/2015 and 95/2018 – from now on: the Law on Investments) stipulate that the import of equipment that represents the stake of an investor who is a foreign or domestic legal or natural person is free and relieved of the payment of tariff and other import duties, except for passenger motor vehicles and entertainment and gaming machines, under the condition that the equipment imported by the investor is in accordance with the regulations that govern the health and security of citizens and protection of the environment. Continue reading Conditions, manner and procedure of exemption from customs and other duties on import of equipment representing the investor’s investment
Representation is a legal business of undertaking legal actions in the name and on behalf of the represented person (in his name and on behalf of the designated person), which produces legal effect towards the represented person, provided that the representative acted within the given authorization powers and that the third party authority, notified of representation. Actions taken by the representative within the limits of his administration have legal effect as if they were taken only by the represented person.
Articles 13 to 16 of the Customs Law (“Official Gazette of the RS”, No. 95/2018, 91/2019 – other law and 144/2020) regulate customs representation.
The stated provisions of the Customs Law regulate the concept of customs representative, direct and indirect customs representation, and the conditions and procedure for granting and revoking the authorization of a customs representative. Continue reading Customs representation