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More Steps Forward to EU Health Protection Regulations

More Steps Forward to EU Health Protection Regulations


The Rulebook on Registers governing by Serbian Chambers of Commerce (the Rulebook) has been adopted. In accordance with the Serbian Medical Devices Act, three new registers will be established:

  1. Register on Issued Licenses for Medical Devices Wholesale;
  2. Register on Wholesale for Importing Medical Devices from non-EU countries and
  3. Register on Specialized Stores of Medical Devices.

Those registers will collect data delivered by ministry competent for health, and upon the request of the person who has a legal interest, the register will issue confirmation on collected data.

The Rulebook is based on the new Medical Devices Act, which is certainly a step forward to harmonization of Serbian law with the EU acquis. As regards this Act, the idea worth mentioning is to solve the problem of the existence of low quality and insecure medical devices on Serbian market, as well as in health care institutions, and therefore to reduce the risk to which the patients could be exposed to. On the other hand, the Act tries to develop conditions for domestic producers for their product placement on the EU market. Furthermore, implementing the provisions of the Rulebook will lead to higher transparency in the pharmaceutical industry in Serbia.

The current situation regarding Serbian medical devices market

However, most of the producers on the Serbian market have already met the standards of the European Union. The statistics say that only 0,6% of medical devices producers do not comply with EU standards. Despite such a small number, the presence of their products on the market i.e. healthcare institutions, pharms etc. is still high due to the low price of the products. Hence, the Rulebook and the Act could be challenging for such producers as they should comply with these regulations in the future.

This Rulebook has entered into force on 1 September 2018, but it shall be implemented as of 1 December 2018, when the Act begins applying as well. The producers of medical devices are looking forward to seeing how those regulations will be applied in practice. So far, they have not raised any significant complaints in this respect.

By Milos Velimirovic, Partner, and Kristina Pavlović, Associate, Samardzic, Oreski & Grbovic

Serbia Knowledge Partner

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