Wholesale of medical devices
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.
Instructions and forms
- Instruction for applicants for registration-amendment to registration-removal from the wholesale register of medical devices
- Application form for registration of a wholesaler/amendment to registration/removal from the wholesale register of medical devices (updated 1.6.2022.) – document in Montenegrin
Register of wholesalers
Register of legal persons performing wholesale of medical devices – Register of wholesalers, as well as the List of legal persons whose wholesale authorisation for medical devices ceased to be valid is available here.
Register is updated in accordance with amendments of its content (last update 21.9.2023.).
In accordance with the Law on medical devices, the Institute may authorize the import of medical devices that are not registered in the following cases:
- In case of urgent medical need for a specific patient, or a group of patients when there is no registered medical device on Montenegrin market that can in an equally safe manner help the patient, or group of patients in question;
- With the aim of public health protection when there are not sufficient quantities of registered medical devices of appropriate purpose on the market of Montenegro;
- for research purposes;
- for clinical investigations;
- in case of natural disasters or
- other emergency situations.
Subject of emergency import may be unregistered medical devices that are a donation or humanitarian aid, as well as unregistered medical devices that are marketed, or in service.
Import of an unregistered medical device may be proposed by a health institution, a scientific-research institution, a social and child welfare institution that provides health care, a humanitarian organization, a state authority responsible for defense affairs, a state authority responsible for health affairs and a state authority responsible for internal affairs. Legal person authorised for wholesale of medical devices shall submit the application for import of an unregistered medical device in the name and for the account of the import proposer to the Institute. Application may be submitted for the import of one unregistered medical device for needs of several import proposers, or for several unregistered medical devices for needs of one import proposer. Application shall be submitted on the Application form published on the portal of the Institute.
Institute shall issue a decision approving or rejecting the application for import of a non-
registered medical device within 30 days from the date of receipt of the complete application.
- Application form for issuance of import authorisation for medical devices that are not registered (updated: 25.1.2023.) – document in Montenegrin
- Justified proposal/statement of the import proposer of an unregistered medical device (update: 25.1.2023.) – document in Montenegrin
- Documentation required for issuance of import authorisation for medical devices that are not registered (updated 8.2.2023.)