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

Rulebooks

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

Rulebook on basic requirements for medical devices (Official gazette of Montenegro, No 008/24)
Rulebook on labelling and content of the instructions for use for a medical device (Official gazette of Montenegro, No 047/23)
Rulebook on more detailed conditions and manner of advertising of medical devices (Official Gazette of Montenegro, No. 042/23)
Rulebook on recognition of foreign documents and CE mark and on registration of medical devices (Official Gazette of Montenegro, No. 85/22, 126/22)
Rulebook on more detailed conditions and method of determining the fulfillment of conditions for the retail sale of medical devices (Official Gazette of Montenegro, No. 57/22, 126/22)
Rulebook on more detailed conditions for import of medical devices that are not registered (Official Gazette of Montenegro, No. 73/22, 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, 72/22)

Good Distribution Practice guidelines for Medical Devices

Guidelines on Good Distribution Practice for Medical Devices (published on 13.12.2021.)

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