A: Yes. According to the Rulebook on the Manner of Registering a Medical Device into the Medical Devices Registry and pursuant to the Law on Medicines and Medical Devices of the Republic of Serbia, adopted in 2010, the applicant must submit the Instructions for Use in the original language and proposed Instructions for Use in Serbian which have to be signed by a clinical physician, or for in vitro medical devices, by a biochemist.
For more information on marketing medical devices in Serbia please visit:
http://www.alims.gov.rs/eng/medical-devices/entry-in-the-register/
A: According to the Rulebook on Clinical Trials of Medicines and Medical Devices, published in the Official Gazette of Bosnia and Herzegovina, no. 4/2010, the Patient information and Informed Consent Form must be in the local language. The official languages in Bosnia and Herzegovina are Bosnian, Serbian and Croatian. The official scripts are Latin and Cyrillic.
For more information please 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 Republic of Slovenia
Federal Ministry of Health of Bosnia and Herzegovina
Ministry of Health of Republic of Macedonia
Ministry of Health of Republic of Montenegro
Medicines and Medical Devices Agency of Serbia
Agency for Medicinal Products and Medical devices of Croatia
Agency of the Republic of Slovenia for Medicinal Products and Medical Devices
Agency for Medicinal products and medical devices of Bosnia and Herzegovina
Agency for Medicines and Medical Devices of Montenegro
Agency for Medicinal Products and Medical Devices of Republic of Macedonia