Yes. In accordance with the Rulebook on the Manner of Registration of Medical Devices in the Register of Medical Devices and the Content of the Application for Registration, based on the Law on Medicines and Medical Devices of the Republic of Serbia (adopted in 2010), the applicant must submit the instructions for use in a foreign language for foreign medical devices and a draft of the instructions for use in Serbian for both foreign and domestic medical devices, signed by a clinical doctor. For in vitro diagnostic medical devices, the draft must also be signed by a qualified professional in the field of biochemistry.
For more information on placing medical devices on the market in Serbia, please check here.