New Serbian Medical Devices Act

On 22 November 2017, the National Assembly of the Republic of Serbia adopted a new Medical Devices Act, which was published in the Official Gazette No. 105/2017 dated 23 November, 2017, which came into force on 1 December 2017, but shall begin to apply from 1 December 2018, except for the provision regarding the content of the instructions for the use of a medical device that shall apply from 1 December 2017. Also, the provisions relating to the Unique Device Identification number of the medical devices (UDI), that exist on the EU market shall apply from the date of Serbia’s entry into the European Union.

This law has been adopted to improve the quality control of medical devices and harmonize internal regulations with the European Union regulations, regulating the import and placing on the market medical devices, monitoring medical devices on the market, their compliance with technical requirements, clinical testing of medical devices, issues concerning the labeling and advertising of medical devices.

One of the most important novelties of this law is that the jurisdiction of the Agency for Medicines and Medical Devices is now extended in relation to the previous act, and now it is also responsible for the registration of medical devices, modifications, amendments and deletion of medical devices from the register, keeping the Register of Manufacturers, Authorized Representatives of the Manufacturer and giving opinions on issues that arise from the Agency’s activities.

This law enables higher efficiency of clinical trials and an accelerated process of approval of clinical trials. The Agency is now obliged to make decision regard to the clinical trial within 40 days from the date of the termination of the Request (unlike the previous 60 days).

It is regulated that a medical device can be put on the market and in use in Serbia only if it is marked with a SE mark or a Serbian sign of conformity with the standards of the European Union.

This law establishes three new registers that are conducted before the Serbian Chamber of Commerce:

  • Register of issued licenses for wholesale medical devices (wholesale register);
  • Register on wholesales that import medical devices from non-EU countries (Importers Register); and
  • Register of specialized stores of medical devices (Register of specialized stores)