License conditions

• A specialized retail establishment that carries out retail sales of medical devices is obliged to have a person responsible for the procurement, receipt, storage, storage, sale and issuance of medical devices (responsible person), as well as other appropriate personnel depending on the degree of risk for the user according to which they share medical equipment and the volume of retail trade, with at least an intermediate level of education in the relevant profession.
• The responsible person should have the appropriate qualifications, namely:
• for class I and IIa medical devices - at least an intermediate level of education in the relevant field, depending on the purpose of the medical device, and at least three years of professional experience;
• for class I and IIa medical devices classified as medical equipment - a high level of education at a medical, dental, pharmaceutical, veterinary, technological, electrotechnical, mechanical or other appropriate faculty and at least one year of work experience in the profession;
• for class IIb and III medical devices, in vitro diagnostic medical devices and active implantable medical devices - a high level of education at a medical, dental, pharmaceutical, veterinary, technological, electrical engineering, mechanical or other appropriate faculty, depending on the class and category of the medical device and at least one year of professional experience.
• for certain types of class IIb medical devices, the responsible person can have a completed secondary level of education, if the Institute for Medicines and Medical Devices has determined that the retail sale of that medical device can also be carried out in other places, in accordance with the law.
• A specialized retail facility should have appropriate space for receiving, storing, storing, selling and issuing medical devices, quarantine for storing defective medical devices or medical devices that have been withdrawn from circulation, sanitary facilities and a wardrobe. The area for receiving, storing, storing, selling and issuing medical devices, the quarantine for storing defective medical devices or medical devices that have been withdrawn from circulation should be adapted to the type, class and category of medical devices that are placed on the market, as well as the volume traffic and cannot be smaller than 10 m2.
• A specialized retail facility where medical devices are prepared for use should have a special area for that purpose, which cannot be smaller than 4 m2.
  The space of a specialized retail facility should be built of solid material, that the construction and size corresponds to the intended purpose, that the walls, floors and ceilings are flat and smooth surfaces made of material that is not susceptible to cracking and shedding, that they can be cleaned quickly and easily or monitor, as well as disinfect, that it has appropriate lighting, temperature, air humidity and ventilation without a harmful direct or indirect influence on the prescribed and safe reception, accommodation and storage of medical equipment, that the arrangement of equipment and devices meets the needs of the smooth performance of operational activities, without risk and the possibility of replacing or mixing different products. The premises should be functionally connected so that the smooth flow of work and the safe placement and storage and sale and issuance of medical devices are ensured. The space for receiving, selling and issuing medical devices should be protected from atmospheric conditions.
• The space should be regularly cleaned, disinfected and controlled, depending on its purpose, and signs prohibiting smoking, eating and drinking, as well as other prohibitions that may affect hygienic conditions, must be prominently displayed, as well as the name and last name of the responsible person and his contact information (phone number and e-mail address).
• A specialized retail facility can also be located within another closed sales facility and in that case it must be physically separated from other areas so that the sale of other products or the provision of services cannot affect the performance of retail medical devices
• A specialized retail outlet should have the appropriate equipment, namely:
• for the accommodation and storage of medical devices, in accordance with the storage conditions specified by the manufacturer;
• for the sale and issuance of medical devices.
• When submitting an application for registration of a specialized retail facility, the applicant submits the following documentation:

General documentation
Completed appropriate Application form for registration of a specialized retail facility/amendment of registration/deletion of a specialized facility from the Retail Trade Register (you can download the form from the CInMED portal in the section Medical devices - retail trade).
the procedure for receiving, storing and issuing medical devices;
protocol/procedure on maintenance of space hygiene and space disinfection;
the procedure related to maintaining the temperature and handling in case of temperature deviations in the storage area of ​​the specialized retail facility (if the facility sells medical devices that do not have the conditions specified by the manufacturer regarding temperature and air humidity, the procedure in question is not required);
the procedure for taking appropriate actions in the process of withdrawing medical devices from the market,
the procedure for reporting suspicions of a counterfeit medical device or a defect in the quality of a medical device;
Evidence of fulfillment of staff requirements:
Responsible person (evidence of education and work experience, full-time employment contract, confirmation from the Tax Administration on the employee's registration for PIO and health insurance, marriage certificate for employees who have changed their last name, decision on the appointment of a responsible person);
Other employed persons (proof of education, employment contract, confirmation from the Tax Administration on employee registration for PIO and health insurance);
Evidence of fulfillment of the requirements regarding space:
an elaboration on the fulfillment of minimum technical and construction conditions in the area for carrying out activities with a sketch of the area and a legend of the premises with marked measurements;
sanitary approval for the performance of activities;
proof of ownership, lease or other way of disposing of business premises;

Evidence of equipment eligibility:

A specialized retail outlet should have the appropriate equipment, namely:

for the accommodation and storage of medical devices, in accordance with the storage conditions specified by the manufacturer - if medical devices are sold in the facility for which the conditions regarding temperature and air humidity have been determined, certificates of calibration of the equipment used to measure temperature and relative humidity shall be submitted air;
for the sale and issuance of medical devices - proof of the existence (photographs) of shelves and tables on which medical devices are stored, i.e. receiving and shipping them;
proof of the method of keeping records on the type and quantity of medical devices sold in Montenegro, by individual packages - proof of the existence of an information system;
List of medical devices or groups of medical devices for which retail licenses are required
Other documentation that proves the fulfillment of the conditions prescribed by the Law and by-laws adopted for its implementation, at the request of the Institute

Special requirements for qualifications

• diploma on completion of the appropriate faculty (medical, dental, pharmaceutical, veterinary, technological, electrical engineering, mechanical or other appropriate faculty depending on the risk class of the medical device whose retail trade is carried out) or secondary level of education in the appropriate field depending on the purpose of the medical device
• full-time employment contract
• confirmation from the Tax Administration about applying for employment insurance
• residence and work permit for a responsible person (only applicable for foreigners)
• extract from the marriage register (if applicable)
• proof of work experience (copy of work book and CV)
• the applicant's statement about the permanent availability (24 hours) of the responsible person with the specified contact information (mobile phone, email)

Fees

Issuance of a license for the retail sale of medical devices (decision on the registration of a specialized retail establishment): 1000e
Sanitary approval: 36e

Hipotekarna banka
IBAN: ME25520420000000072389
Call number: invoice number or item number after issuing the invoice
Purpose: payment of compensation
User: INSTITUTE FOR DRUGS AND MEDICINE. ASSETS BULEVAR IVANA CRNOJEVICA 64A - PODGORICA

NLB banka
IBAN: ME25530005030006098394
Call number: invoice number or item number after issuing the invoice
Purpose: payment of compensation
Beneficiary: INSTITUTE FOR DRUGS AND MEDICAL DEVICES

Competent authorities

Institute for Medicines and Medical Devices of Montenegro
Bulevar Ivana Crnojevića 64a, Podgorica
+382 (20) 310 280
+382 (20) 310 281
+382 (20) 310 580
info@cinmed.me
uros.labudovic@cinmed.me

Mail za slanje dokumentacije:

pisarnica@cinmed.me

Relevant regulations

Law on Medical Devices ("Official Gazette of Montenegro", number 24/19),

Rulebook on the detailed conditions and the method of determining the fulfillment of the conditions for the retail sale of medical devices ("Official Gazette of Montenegro", no. 57/22 and 126/22)

Legal remedies

The possibility of a lawsuit within 30 days to the Administrative Court, Svetog Petra Cetinjskog 130, Podgorica.