Physician’s signature – yes or no?

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

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 Medicines and Medical Devices Agency of Serbia (ALIMS):