Wholesale of medical devices shall include the procurement, storage and distribution, other than the issuance of a medical device to the end user or the patient for his personal needs.

Wholesale of medical devices shall also include import and export of medical devices.Wholesale of medical devices also include marketing of medical devices from donations or humanitarian aid. Export for the repair of a medical device of a certain serial number that was in use in Montenegro and the import of that medical device of the same serial number shall not be considered to be marketing of medical devices. Transit, i.e. import for the purpose of export of a medical device shall not be considered as marketing of a medical device either.

Wholesale of medical devices may be carried out by:

• legal persons with a seat in Montenegro which are registered for wholesale;
• manufacturers established in Montenegro for the devices they manufacture.

Marketing of medical devices may be carried out only with medical devices that are registered, i.e. medical devices that are imported in case of urgent medical need and that possess a document or declaration of conformity.

Wholesalers carrying out wholesale of medical devices shall carry out wholesale in accordance with the decision on wholesale registration and Good Distribution Practice guidelines for medical devices. Wholesaler may delegate certain tasks within wholesale of medical devices to another wholesaler. Good Distribution Practice guidelines for medical devices shall be published on the website of the Ministry of health and the Institute.  

The decision on the manufacturer’s registration shall be issued for an indefinite period. Wholesalers shall ensure continuous supply of the market with medical devices in accordance with the decision on wholesaler registration. Wholesaler shall, upon request of a healthcare institution, specialized retail facility, and other legal person which provides health care, deliver the medical device for which it has received the wholesaler registration and which is entered in the register of medical devices, as soon as possible. For the continuous supply of the market with medical devices, the wholesaler shall provide the necessary stocks of medical devices for the wholesale of which it has been issued wholesale registration and which are entered in the register of medical devices, i.e. start procurement or import in a timely manner in order not to interrupt the supply of the market.

Wholesalers may procure medical devices directly from the manufacturer, importer or other wholesaler, which are registered in the register maintained by the Institute and possess the authorisation to carry out the activities issued by the competent authority of the country from which the medical devices are imported.

Wholesalers may sell medical devices from their assortment exclusively to medical device manufacturers, other wholesalers, healthcare institutions, specialized retail stores, as well as other legal entities providing health care.