Medical devices

Law on medical devices (“Official Gazette of Montenegro”, No. 024/19)
Law on administrative procedure (“Official Gazette of Montenegro” No 056/14, 020/15, 040/16 and 037/17) – document in Montenegrin;

Note: this act is applied to all procedures initiated upon 1 July 2017

Previously applicable legislation

Law on medical devices (“Official Gazette of Montenegro”, No. 79/2004)
Note: applied to all procedures initiated up to 30 April 2019
Law on general administrative procedure (“Official Gazette of Montenegro”, No 60/03, No 73/10 and No 32/11) – document in Montenegrin;

Note: this act is applied to all procedures initiated up to 1 July 2017

In accordance with the Law on Medical Devices (“Official Gazette of Montenegro”, No. 24/19)

Pravilnik o priznavanju inostranih isprava i CE znaka i o registraciji medicinskog sredstva („Službeni list CG”, broj 085/22 i 126/22)
Pravilnik o bližim uslovima i načinu utvrđivanja uslova za promet medicinskih sredstava na veliko („Službeni list CG”, br. 132/21i 072/22)
Pravilnik o bližim uslovima i načinu utvrđivanja uslova za promet medicinskih sredstava na malo („Službeni list CG”, br. 057/22 i 126/22)
Pravilnik o bližim uslovima za uvoz medicinskih sredstava koja nijesu registrovana („Službeni list CG”, broj 073/22 i 126/22)
Rulebook on more detailed conditions and manner of determining the fulfillment of conditions for the wholesale of medical devices (Official Gazette of Montenegro, No. 132/21)”