Emergency import

In accordance with the Law on medical devices, the Institute may approve import of medical devices that are not registered in following cases:

In case of urgent medical need for a specific patient or group of patients, and no registered medical device is available on the market of Montenegro that can in an equally safe manner help patient or group of patients in question;
In case of insufficient quantities of registered medical devices of relevant purpose on the market of Montenegro to address the needs of public health protection;
for research purposes;
for clinical trials;
in case of natural disasters, or
other emergency situations.

Emergency import may include unregistered medical devices that are donations or humanitarian aid, as well as unregistered medical devices that have been on the market or in use.

The import of an unregistered medical device may be proposed by a health institution, a scientific and research institution, a social and child welfare institution providing health care, a humanitarian organization, a state administration body responsible for defense affairs, a state administration body responsible for health affairs, and a state administration body responsible for internal affairs. An application for import authorisation for unregistered medical device on behalf and for the account of the import proposer shall be submitted to the Institute by a legal person possessing a wholesale authorisation for medical devices – wholesaler. The application may be submitted for import of one unregistered medical device for the needs of several import proposers or for several unregistered medical devices for the needs of one import proposer. The application shall be submitted using the Form available on the Institute’s website.

Within 30 days from the date of receipt of a complete application the Institute shall issue a decision approving or rejecting the application for issuance of import authorisation for unregistered medical device.