Montenegro

03/24/2023

Updates: Instructions for Application for The Registration of Manufacturers of Medical Devices. Updated Instruction for Application for The Registration of Manufacturers of Medical Devices that do not have their seat/residence in Montenegro by the Law on Medical Devices ("Official Gazette of Montenegro," No 24/19).

02/08/2023

Updated Documentation for MD importation. Updated Documentation is required to issue import authorization for medical devices that are not registered.

11/18/2022

Rulebook on the recognition of foreign documents and the CE mark and on the registration of medical devices. Regulations on recognition of foreign documents, CE marking, and registration of medical devices (“Official Gazette of Montenegro,” No. 085/22 of 08.02.2022, 126/22 of 11.18.22)– document in Montenegrin.

11/18/2022

Rulebook on closer conditions for the import of unregistered medical devices. Rulebook on closer conditions for the import of unregistered medical devices ("Official Gazette of Montenegro," number 073/22 and 126/22)– document in Montenegrin.

07/06/2022

Instruction for submission of application for extension of registration. Instruction for submission of application for extension of registration-extension with amendment-amendment-removal of the decision on registration of a medical device from the register.

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