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.
According to the Rulebook on Clinical Trials of Medicines and Medical Devices, published in the Official Gazette of Bosnia and Herzegovina No. 04/2010, the patient information and the informed consent form must be in the local language.
The official languages of Bosnia and Herzegovina are Bosnian, Serbian, and Croatian, and the official scripts are Latin and Cyrillic.
For more information, visit:
http://www.almbih.gov.ba/_doc/regulative/pravilnik_klinicka_bos.pdf
Ministry of Health of the Republic of Serbia
Ministry of Health of the Republic of Croatia
Ministry of Health of the Republic of Slovenia
Federal Ministry of Health of Bosnia and Herzegovina
Ministry of Health of the Republic of North Macedonia
Ministry of Health of the Republic of Montenegro
Medicines and Medical Devices Agency of Serbia
Agency for Medicinal Products and Medical Devices of Croatia
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
The Agency for medicinal products and medical devices of Bosnia and Herzegovina
The Institute for Medicines and Medical Devices of Montenegro
Agency for Medicines and Medical Devices of the Republic of North Macedonia
European Medicines Agency (EMA)
