Rules for medical devices


Law on Medical Devices („Official gazette of RS“, No. 105/2017)

1. Rulebook on Import of unregistered medical devices
(“Official Gazette of RS”, No. 39/2018)

2. Rulebook on Essential Requirements for medical devices
(“Official Gazette of RS”, No. 65/2018)


Law on Medicinal Products and Medical Devices („Official gazette of RS“, No. 30/2010; 107/2012 and 113/2017-other law)

1. Rulebook on the Contents of the Application, and/or Documentation on the Approval of Clinical Trials for Medicines and Medical Devices, as well as the Method of Implementation for Clinical Trials of Medicines and Medical Devices
(“Official Gazette of RS”, No. 64/2011)

2. Rulebook on the method of reporting, collecting and monitoring adverse reactions to medicines
(“Official Gazette of RS”, No. 64/2011)