Medical device registration in Serbia

In order to be able to market a medical device in Serbia, based on the law on drugs and medical devices, adopted in 2010, a manufacturer must register the device in the medical device register of the Agency for Medicines and Medical Devices of Serbia (ALIMS).
The registration procedure in the Register of Medical Devices is different for medical devices with and without the CE-mark.
Registration is based on an administrative procedure based on certificates and documents that provide evidence of compliance with the EU medical device directives.