Medical Device Regulations in Montenegro Explained

Regulatory Agency

The Ministry of Health and the Institute for Medicines and Medical Devices of Montenegro (CINMED) regulate the medical devices in Montenegro

Medical Device Definition

Medical Device: means any instrument, apparatus, appliance, software, implant, reagent, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used for diagnostic or therapeutic purposes and which is program support necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
diagnosis, monitoring, treatment, alleviation of, or compensation for an injury or disability;
investigation, replacement or modification of an anatomical structure or function or of a physiological or pathological process or state;
providing information by means of in vitro investigation of specimens from the human body, including organs, blood and tissues donations;
control or facilitation of conception;
cleaning, disinfection or sterilization of medical devices.

Active Medical Device: means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;

Medical Device Classification System

Classification	Risk Level	Examples
l	Low Risk	Wheelchairs, Stethoscopes, Spectacles
IIa	Medium Risk	Dental fillings, Surgical clamps, Tracheotomy tubes
IIb	Medium High Risk	Lung ventilators, Bone fixation plate, Condoms
III	High Risk	Pacemakers, Heart valves, Implanted Cerebral Simulators

Regulatory Approval Process

Classification	Approval Procedure
I Ila llb lll	The applicant submits the application and the necessary documentation to the Institute for Medicines and Medical Devices at the previously agreed time. The appointment for submission of the application is scheduled via email to the address: registracjams@cinmed.me Before submitting the application for the registration of a medical device, it is necessary to register the manufacturer of the medical device whose seat/residence/ residence is in Montenegro, in accordance with the Instructions for applicants for the registration of manufacturers of medical devices who do not have their seat/residence/residence in Montenegro. There are exactly 11 chapters that need to be filled in with the appropriate document.Each chapter should be marked with an ordinal number (from 1 to 11) and separated from the other chapter by a delimiter. The order of stacking the documentation is as in the documents section. The submitted documentation must be prepared in A4 format binders with hard covers. The holder of the registration is obliged to regularly renew the certificates of compliance from the previous section as well as other documents that have a validity period, with the obligation that the foreign certificates are original or notarized copies. In the event that the validity of the documents from the previous sections is not renewed or extended, the Institute deletes the medical device from the register of medical devices. After receiving the request, the applicant is issued an invoice in accordance with the decision on the method of payment and the amount of fees for registration, deletion and maintenance of the register of medical devices, manufacturers and legal entities that trade and import medical devices, on the basis of which it is necessary to make the payment with a reference to the invoice number/item number.

Classification

Approval Procedure

Ila

llb

lll

1. The applicant submits the application and the necessary documentation to the Institute for Medicines and Medical Devices at the previously agreed time. The appointment for submission of the application is scheduled via email to the address: registracjams@cinmed.me
2. Before submitting the application for the registration of a medical device, it is necessary to register the manufacturer of the medical device whose seat/residence/ residence is in Montenegro, in accordance with the Instructions for applicants for the registration of manufacturers of medical devices who do not have their seat/residence/residence in Montenegro.
3. There are exactly 11 chapters that need to be filled in with the appropriate document.Each chapter should be marked with an ordinal number (from 1 to 11) and separated from the other chapter by a delimiter.
4. The order of stacking the documentation is as in the documents section.
5. The submitted documentation must be prepared in A4 format binders with hard covers.
6. The holder of the registration is obliged to regularly renew the certificates of compliance from the previous section as well as other documents that have a validity period, with the obligation that the foreign certificates are original or notarized copies.
7. In the event that the validity of the documents from the previous sections is not renewed or extended, the Institute deletes the medical device from the register of medical devices.
8. After receiving the request, the applicant is issued an invoice in accordance with the decision on the method of payment and the amount of fees for registration, deletion and maintenance of the register of medical devices, manufacturers and legal entities that trade and import medical devices, on the basis of which it is necessary to make the payment with a reference to the invoice number/item number.

Additional Information

Approval Timeline

Not specified by the agency

License validity period

5 years

Fees

Fees are calculated according to the risk class and the quantity of products per registration.

Class I – 60 to 100 EUR / Class IIa – 150 to 200 EUR / Class IIb – 200 to 300 EUR / Class III – 350 to 400 EUR.

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