Date of last update:
Wholesale trade of medical devices
-- TRADE --
- The wholesale trade of medical devices includes procurement, storage and distribution, except for issuing the medical device to the end user, i.e. the patient for his personal needs. The wholesale turnover of medical devices includes the import and export of medical devices. The turnover of medical supplies also includes the turnover of medical supplies from donations or humanitarian aid. Export for the purpose of repair of a medical device of a certain serial number that was in use in Montenegro and import of that medical device of the same serial number is not considered turnover. Transit, i.e. import for the purpose of export of a medical device is not considered to be the sale of a medical device.
- Wholesale trade of medical devices can be carried out by:
- legal entities based in Montenegro that are registered for trading in accordance with the law on medical devices;
- manufacturers of medical devices based in Montenegro for the devices they produce.
- The sale of medical devices can only be carried out with medical devices that are registered, as well as medical devices from Article 66 of the Law on Medical Devices, which have a document or declaration of conformity.
License conditions
- A legal entity that carries out wholesale medical supplies is required to have a person responsible for receiving, storing, storing and delivering medical supplies (responsible person) with education in the application of the guidelines of Good Practices in the distribution of medical supplies and three years of work experience in the profession, as well as other appropriate staff depending on the level of risk for the user according to which the medical supplies are distributed and the volume of wholesale turnover.
- The wholesaler should have an organizational chart, in accordance with the guidelines of Good Practice in the distribution of medical devices
- It must have appropriate space for receiving, storing, storing and delivering medical devices, storage of packaging, quarantine for storing defective medical devices or medical devices that have been withdrawn from circulation, cloakroom, sanitary facilities and office space. The space for the reception, storage, storage and delivery of medical devices, storage of packaging and quarantine for the storage of defective medical devices or medical devices that have been withdrawn from circulation cannot be less than 40 m2 and should be separated from the wardrobe space, sanitary rooms and office space. The area for receiving and delivering medical supplies and quarantine should be separate from the area for storing and keeping medical supplies. If the wholesaler sells medical devices that are a source of ionizing radiation, it should have a separate room for the accommodation of those medical devices that meets the requirements in accordance with the regulations regulating protection against ionizing radiation.
- The wholesale space should be built of solid material, the construction and size should correspond to the intended purpose, the walls, floors and ceilings should be flat and smooth, made of material that is not susceptible to cracking and shedding, and should be able to be cleaned or washed quickly and easily. , as well as disinfect, to have appropriate lighting, temperature, air humidity and ventilation without 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 risks and opportunities substitution or mixing of different products. The premises should be functionally connected so that the smooth flow of work and the safe placement, storage and dispatch of medical equipment are ensured. The space for receiving and shipping medical supplies should be protected from the weather.
- Wholesale in the area for the storage of medical devices should implement a program of pest control and measures against wastage and damage, as well as mutual contamination of products, to be regularly cleaned, disinfected and controlled depending on its purpose and prominently display signs prohibiting smoking, eating and drinks, as well as other prohibitions that may affect hygienic conditions.
- The wholesaler should provide the necessary security measures to prevent the entry of unauthorized persons into the space for storing and keeping medical devices and an alarm system for continuous detection of unauthorized entry.
- The wholesaler should have appropriate equipment for receiving, storing, storing and delivering medical supplies, equipment for monitoring temperature and humidity, and an appropriate computerized system. The equipment is designed, placed and maintained in accordance with the conditions specified by the manufacturer. The equipment is appropriately qualified and/or validated in accordance with the Guidelines for Good Practice in the Distribution of Medical Devices.
- For the transport of medical devices, the wholesaler should have at its disposal the appropriate type and sufficient number of its own means of transport or the means of transport of the person with whom it concluded an agreement on the entrustment of transport operations, which should be adapted to the type, class and category of medical devices.
- A wholesaler that wholesales a certain class and category of medical devices that, due to their specific conditions of accommodation, storage and transportation, the manufacturer delivers directly to the end user, does not have to have available means of transportation for this type of medical devices.
- For the transport of certain types of medical devices, the means of transport should be equipped for special transport conditions in accordance with the prescribed conditions of storage, i.e. transport (eg provision of a "cold chain" with available records of temperature control and monitoring).
- Legal entities that carry out the sale of medical devices in bulk are obliged to carry out the sale in accordance with the decision on wholesale registration and the guidelines of Good Practice in the distribution of medical devices.
- When submitting an application for wholesale registration, the applicant submits the following documentation:
- Filled in the appropriate form of request for wholesale registration/amendment
registration/deletion of wholesale from the Register of Wholesale Trade (the form is downloaded from portal CInMED)
- Evidence of fulfillment of staff requirements:
- Responsible person (appointment decision, evidence of education and work experience, full-time employment contract, evidence of training for the tasks performed, confirmation from the Tax Administration on the employee's registration for PIO and health insurance, marriage certificate for employees who have changed surname)
- Employed persons (proof of education, proof of work experience, proof of training)
- Organizational chart of employees
- Evidence of fulfillment of the requirements regarding space:
- 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, entrustment of storage activities or some other way of disposing of business premises
- Evidence of equipment eligibility:
- proof of availability of funds for the transport of medical equipment (e.g. proof of vehicle ownership, vehicle use, entrustment of transport activities)
- proof of the existence of a backup power supply (aggregate, UPS (uninterruptible power supply))
- proof of the existence of a computerized or other record keeping system
list of equipment and technical data about the equipment
- proof of the existence of appropriate temperature and humidity monitoring equipment
- proof of qualification and/or validation of key equipment
- plan for regular (preventive) maintenance of key equipment.
________________________________________________________________
- Evidence of the implementation of the quality system in accordance with the guidelines of Good Practice in the distribution of medical devices
- Regulation on quality or other equivalent document
- List of QMS documents (procedures, instructions and records)
- Evidence of the existence of standard operating procedures (SOP) on:
- Procedure for periodic review of the quality system (review of the management system)
- Change control (procedure that defines the procedure for managing changes that could affect the quality of medical equipment and services)
- Risk management
- Complaints
- Qualification of suppliers (approval of suppliers)
- Customer Qualification (Customer Approval)
- By training
- Hygiene
- Documented information
- Reception, storage and delivery of medical equipment
- Procedure in case of temperature deviations
- Temperature monitoring in the warehouse
- Cleaning procedure
- Pest control (pest control)
- Destruction of medical equipment
- Validation and qualification of equipment
- Dealing with returned medical devices
- Falsified medicinal products
- Withdrawal of medical devices from circulation
- Outsource activities
- Transport of medical devices
- Internal checks
- Note: In the process of evaluating the compliance of the wholesale business with the guidelines of Good Practice in the distribution of medical devices, the Institute reserves the right to review other SOPs, not only those listed above. The specified SOP - these are submitted to the Institute with the request for wholesale registration.
- Other documentation that proves the fulfillment of the conditions prescribed by the Law and by-laws adopted for its implementation
Special requirements for qualifications
- a diploma of a completed appropriate faculty (medical, dental, pharmaceutical, veterinary, mechanical, technological, electrotechnical, chemical, biological or other appropriate faculty, depending on the risk class of the medical device whose wholesale trade is carried out)
- proof of completed training in the field of Good Practices in Distribution guidelines
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 wholesale sale of medical devices (wholesale registration decision): 1500 EUR
Sanitary approval: 36 EUR
Payment via internet banking
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:
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 wholesale sale of medical devices ("Official Gazette of Montenegro", no. 132/21, 72/22),
Good practice guidelines in the distribution of medical devices published on the CInMED website 13.12.2021
Permits
Deadline: For the issuance of a license for the sale of medical devices in bulk, it is 90 days from the submission of a complete request, the time required for the submission of additional documentation is not included in the specified deadline.
Legal remedies
The possibility of a lawsuit within 30 days to the Administrative Court, Svetog Petra Cetinjskog 130, Podgorica.
Wholesale trade of medical devices
-- TRADE --
- The wholesale trade of medical devices includes procurement, storage and distribution, except for issuing the medical device to the end user, i.e. the patient for his personal needs. The wholesale turnover of medical devices includes the import and export of medical devices. The turnover of medical supplies also includes the turnover of medical supplies from donations or humanitarian aid. Export for the purpose of repair of a medical device of a certain serial number that was in use in Montenegro and import of that medical device of the same serial number is not considered turnover. Transit, i.e. import for the purpose of export of a medical device is not considered to be the sale of a medical device.
- Wholesale trade of medical devices can be carried out by:
- legal entities based in Montenegro that are registered for trading in accordance with the law on medical devices;
- manufacturers of medical devices based in Montenegro for the devices they produce.
- The sale of medical devices can only be carried out with medical devices that are registered, as well as medical devices from Article 66 of the Law on Medical Devices, which have a document or declaration of conformity.
License conditions
- A legal entity that carries out wholesale medical supplies is required to have a person responsible for receiving, storing, storing and delivering medical supplies (responsible person) with education in the application of the guidelines of Good Practices in the distribution of medical supplies and three years of work experience in the profession, as well as other appropriate staff depending on the level of risk for the user according to which the medical supplies are distributed and the volume of wholesale turnover.
- The wholesaler should have an organizational chart, in accordance with the guidelines of Good Practice in the distribution of medical devices
- It must have appropriate space for receiving, storing, storing and delivering medical devices, storage of packaging, quarantine for storing defective medical devices or medical devices that have been withdrawn from circulation, cloakroom, sanitary facilities and office space. The space for the reception, storage, storage and delivery of medical devices, storage of packaging and quarantine for the storage of defective medical devices or medical devices that have been withdrawn from circulation cannot be less than 40 m2 and should be separated from the wardrobe space, sanitary rooms and office space. The area for receiving and delivering medical supplies and quarantine should be separate from the area for storing and keeping medical supplies. If the wholesaler sells medical devices that are a source of ionizing radiation, it should have a separate room for the accommodation of those medical devices that meets the requirements in accordance with the regulations regulating protection against ionizing radiation.
- The wholesale space should be built of solid material, the construction and size should correspond to the intended purpose, the walls, floors and ceilings should be flat and smooth, made of material that is not susceptible to cracking and shedding, and should be able to be cleaned or washed quickly and easily. , as well as disinfect, to have appropriate lighting, temperature, air humidity and ventilation without 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 risks and opportunities substitution or mixing of different products. The premises should be functionally connected so that the smooth flow of work and the safe placement, storage and dispatch of medical equipment are ensured. The space for receiving and shipping medical supplies should be protected from the weather.
- Wholesale in the area for the storage of medical devices should implement a program of pest control and measures against wastage and damage, as well as mutual contamination of products, to be regularly cleaned, disinfected and controlled depending on its purpose and prominently display signs prohibiting smoking, eating and drinks, as well as other prohibitions that may affect hygienic conditions.
- The wholesaler should provide the necessary security measures to prevent the entry of unauthorized persons into the space for storing and keeping medical devices and an alarm system for continuous detection of unauthorized entry.
- The wholesaler should have appropriate equipment for receiving, storing, storing and delivering medical supplies, equipment for monitoring temperature and humidity, and an appropriate computerized system. The equipment is designed, placed and maintained in accordance with the conditions specified by the manufacturer. The equipment is appropriately qualified and/or validated in accordance with the Guidelines for Good Practice in the Distribution of Medical Devices.
- For the transport of medical devices, the wholesaler should have at its disposal the appropriate type and sufficient number of its own means of transport or the means of transport of the person with whom it concluded an agreement on the entrustment of transport operations, which should be adapted to the type, class and category of medical devices.
- A wholesaler that wholesales a certain class and category of medical devices that, due to their specific conditions of accommodation, storage and transportation, the manufacturer delivers directly to the end user, does not have to have available means of transportation for this type of medical devices.
- For the transport of certain types of medical devices, the means of transport should be equipped for special transport conditions in accordance with the prescribed conditions of storage, i.e. transport (eg provision of a "cold chain" with available records of temperature control and monitoring).
- Legal entities that carry out the sale of medical devices in bulk are obliged to carry out the sale in accordance with the decision on wholesale registration and the guidelines of Good Practice in the distribution of medical devices.
- When submitting an application for wholesale registration, the applicant submits the following documentation:
- Filled in the appropriate form of request for wholesale registration/amendment
registration/deletion of wholesale from the Register of Wholesale Trade (the form is downloaded from portal CInMED)
- Evidence of fulfillment of staff requirements:
- Responsible person (appointment decision, evidence of education and work experience, full-time employment contract, evidence of training for the tasks performed, confirmation from the Tax Administration on the employee's registration for PIO and health insurance, marriage certificate for employees who have changed surname)
- Employed persons (proof of education, proof of work experience, proof of training)
- Organizational chart of employees
- Evidence of fulfillment of the requirements regarding space:
- 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, entrustment of storage activities or some other way of disposing of business premises
- Evidence of equipment eligibility:
- proof of availability of funds for the transport of medical equipment (e.g. proof of vehicle ownership, vehicle use, entrustment of transport activities)
- proof of the existence of a backup power supply (aggregate, UPS (uninterruptible power supply))
- proof of the existence of a computerized or other record keeping system
list of equipment and technical data about the equipment - proof of the existence of appropriate temperature and humidity monitoring equipment
- proof of qualification and/or validation of key equipment
- plan for regular (preventive) maintenance of key equipment.
________________________________________________________________
- Evidence of the implementation of the quality system in accordance with the guidelines of Good Practice in the distribution of medical devices
- Regulation on quality or other equivalent document
- List of QMS documents (procedures, instructions and records)
- Evidence of the existence of standard operating procedures (SOP) on:
- Procedure for periodic review of the quality system (review of the management system)
- Change control (procedure that defines the procedure for managing changes that could affect the quality of medical equipment and services)
- Risk management
- Complaints
- Qualification of suppliers (approval of suppliers)
- Customer Qualification (Customer Approval)
- By training
- Hygiene
- Documented information
- Reception, storage and delivery of medical equipment
- Procedure in case of temperature deviations
- Temperature monitoring in the warehouse
- Cleaning procedure
- Pest control (pest control)
- Destruction of medical equipment
- Validation and qualification of equipment
- Dealing with returned medical devices
- Falsified medicinal products
- Withdrawal of medical devices from circulation
- Outsource activities
- Transport of medical devices
- Internal checks
- Note: In the process of evaluating the compliance of the wholesale business with the guidelines of Good Practice in the distribution of medical devices, the Institute reserves the right to review other SOPs, not only those listed above. The specified SOP - these are submitted to the Institute with the request for wholesale registration.
- Other documentation that proves the fulfillment of the conditions prescribed by the Law and by-laws adopted for its implementation
Special requirements for qualifications
- a diploma of a completed appropriate faculty (medical, dental, pharmaceutical, veterinary, mechanical, technological, electrotechnical, chemical, biological or other appropriate faculty, depending on the risk class of the medical device whose wholesale trade is carried out)
- proof of completed training in the field of Good Practices in Distribution guidelines
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 wholesale sale of medical devices (wholesale registration decision): 1500 EUR
Sanitary approval: 36 EUR
Payment via internet banking
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:
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 wholesale sale of medical devices ("Official Gazette of Montenegro", no. 132/21, 72/22),
Good practice guidelines in the distribution of medical devices published on the CInMED website 13.12.2021
Permits
Deadline: For the issuance of a license for the sale of medical devices in bulk, it is 90 days from the submission of a complete request, the time required for the submission of additional documentation is not included in the specified deadline.
Legal remedies
The possibility of a lawsuit within 30 days to the Administrative Court, Svetog Petra Cetinjskog 130, Podgorica.
