Medical devices

Advertising of a medical device is any form of providing truthful information about a medical device to the general and professional public in order to encourage the prescription and supply of medical devices, their sale and consumption by the manufacturer, or the manufacturer’s authorized representative, as well as by a legal or natural person who carries out the sale of medical devices.

Advertising of a medical device must be in accordance with the general requirements of the Law and the regulations adopted for its implementation, as well as the instructions for the use of the medical device provided by the manufacturer (NATIONAL MEDICINES REGISTRY (“Official Gazette of RS”, No. 105/2017. ))  Only a medical device that complies with the basic requirements, i.e. that is registered in accordance with the Law and the by-laws adopted for its implementation, shall be advertised (NATIONAL MEDICINES REGISTRY (“Official Gazette of RS”, No. 102/2018)).

Advertising of medical devices includes:

1) advertising of medical devices through the public media, including the Internet, advertising in public places and other forms of advertising medical devices (by mail, visits, etc.);

2) promotion of medical devices to healthcare professionals who prescribe medical devices and/or who use medical devices, by informing them at professional meetings, in professional magazines and other forms of promotion;

3) providing free samples to the professional public;

4) sponsoring scientific and promotional gatherings attended by the professional public (by paying travel expenses, accommodation, food, as well as the costs of mandatory attendance of scientific and promotional gatherings) The Agency controls the promotional material for advertising a medical device, at the proposal of the Ministry.