Q: Do I need a clinical physician’s signature on any document when registering a medical device in Serbia?

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.

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Q: Should the ICF for Bosnia be translated into three languages or is one sufficient?

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.

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