Pure Global AI
CInMED · structured requirements

🇲🇪 Montenegro medical device regulatory data

Explore the medical device requirements currently available for Montenegro, organized by topic and linked to official sources.

47 facts21 dimensions9 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

Compare countries

Advertiser keeps six categories of records, publishes an annual advertising report and files it with the Ministry

advertising.advertiser-records-and-annual-report
Fact-level verified

An advertiser must keep records of: parallel promotions (name, seat and activity of the legal person carrying out the parallel promotion, and the expert associate's name, residence, employment and occupation); advertising messages (name of the device, the public information medium or website on which the message was published, and the advertising period); promotional material (name and purpose of the promoted device, type and quantity of the material, number and date of issue); the expert public to whom the material was delivered (name of the healthcare professional, employer, name and purpose of the promoted device, type and quantity, date of delivery); the expert public's requests for free samples (name of the prescribing or using healthcare professional, employer, quantity provided, date of delivery); and sponsored expert meetings (name, time and place, information on the expert-public attendees, total funds spent, funds spent by item — travel, accommodation, meals, participation costs — and total funds spent on an annual basis). On the basis of those records the advertiser prepares an annual report on the advertising of medical devices, publishes it on its website and submits it to the state administration body responsible for health affairs. The advertiser keeps the original of advertising messages, promotional materials and published expert works for five years.

Conditions
  • The annual report is both published on the advertiser's own website and submitted to the Ministry; the underlying originals are kept for five years.
Rulebook on more detailed conditions and manner of advertising of medical devices ("Official Gazette of Montenegro", No 042/23 from 19.04.2023) — English text

Montenegrin source (quoted in the original; the English rendering below is from the Ministry's own English text published on the same site, declared as the supporting source). Verbatim Član 20: "Na osnovu podataka iz evidencije iz člana 19 ovog pravilnika, oglašivač sačinjava godišnji izvještaj o oglašavanju medicinskih sredstava, koji objavljuje na svojoj internet stranici i dostavlja organu državne uprave nadležnom za poslove zdravlja." Verbatim Član 21: "Oglašivač čuva original reklamnih poruka, promotivnih materijala i objavljenih stručnih radova za period od pet godina." Translation of Član 20: "Based on the data from the records referred to in Article 19 of this Rulebook, the advertiser shall prepare an annual report on the advertising of medical devices, which shall be published on its website and submitted to the state administration body responsible for health affairs." Translation of Član 21: "Advertiser shall keep the original of advertising messages, promotional materials and published expert works for a period of five years."

Expert-public promotional material: 'For expert public only!', registration date, and no 'safe' claim

advertising.expert-public-material-requirements
Fact-level verified

Advertising a medical device to the expert public is done by delivering promotional material, providing information at scientific and promotional events, in expert journals and other forms of promotion, giving a free sample, and sponsoring expert meetings in which the expert public participates, in accordance with the Law; the promotional material may be given only to persons belonging to the expert public. The promotional material must contain: the note 'For expert public only!'; basic information about the device which must be relevant, accurate, up to date, verifiable and sufficient for the expert public to form an expert opinion on it; the date of registration of the device; statements, tables or other data taken from expert journals or scientific papers which are current, relevant and faithfully conveyed, with reference to the literature and the exact source of information; and the date of creation and last revision of the promotional material. The promotional material must not contain the term 'safe' unless it refers to a description of a device containing appropriate explanations in accordance with the essential requirements. Advertising to the expert public may be carried out by persons employed or otherwise engaged by the advertiser with a VII1 level of education at an appropriate faculty, who have appropriate knowledge and additional training in the essential requirements for safety and performance of the advertised device, and the advertiser must provide them with continuous training and test their knowledge.

Conditions
  • Applies to advertising addressed to the expert public (healthcare professionals who prescribe devices, and professionals in manufacture, wholesale and retail sale of devices and in compulsory health insurance organisation), not to general-public advertising.
Rulebook on more detailed conditions and manner of advertising of medical devices ("Official Gazette of Montenegro", No 042/23 from 19.04.2023) — English text

Montenegrin source (quoted in the original; the English rendering below is from the Ministry's own English text published on the same site, declared as the supporting source). Verbatim Član 10 stav 1: "Promotivni materijal treba da sadrži: 1) naznaku: \"Samo za stručnu javnost!\"; 2) osnovne podatke o medicinskom sredstvu, koji moraju biti relevantni, tačni, ažurirani, provjerljivi i dovoljni da na osnovu njih stručna javnost može da formira stručno mišljenje; 3) datum registracije medicinskog sredstva; 4) navode, tabele ili druge podatke preuzete iz stručnih časopisa ili naučnih radova, koji su aktuelni, relevantni i vjerno prenijeti, uz navođenje literature i tačnog izvora informacija; 5) datum sačinjavanja i posljednje revizije promotivnog materijala." Verbatim stav 2: "Promotivni materijal ne treba da sadrži izraz \"sigurno\", osim ako se odnosi na opis medicinskog sredstva koji sadrži odgovarajuća objašnjenja u skladu sa osnovnim zahtjevima." Translation of stav 1: "Promotional material shall contain: 1) the note: 'For expert public only!'; 2) basic information about a medical device, which must be relevant, accurate, updated, verifiable and sufficient for expert public to form an expert opinion based on them; 3) date of registration of a medical device; 4) statements, tables or other data taken from expert journals or scientific papers, which are current, relevant and faithfully conveyed, with reference to literature and exact source of information; 5) date of creation and last revision of the promotional material." Translation of stav 2: "Promotional material should not contain the term 'safe', unless it refers to a description of a medical device that contains appropriate explanations in accordance with essential requirements."

General-public advertising: mandatory content, prescribed warning wording and its placement

advertising.general-public-message-and-mandatory-warning
Fact-level verified

Advertising a medical device to the general public is done by publishing an advertising message through the public information media or the internet, in public places and in other forms of advertising, that is, by giving a free sample in accordance with the Law. The advertising message must give clear information that the advertised product is a medical device and must contain the name of the device, the manner of use and the data necessary for its proper use, and a warning to the patient or user — visibly, legibly and comprehensibly written, drawn or spoken — to read the instructions for use carefully and to consult a doctor of medicine, pharmacist and/or dentist about the purpose and adverse effects of the device. The warning must read: 'Read the instructions before use! Consult a doctor of medicine or pharmacist about the purpose and adverse effects of the medical device' (or, for devices intended for use in dentistry, consult a dentist or pharmacist). In print media it must be written in bold in an appropriate font, easily visible, occupying at least one tenth of the advertising message and framed by a straight line that does not affect its clarity and visibility; in electronic media it must be shown independently in a separate frame with an accompanying voice message of identical content; on the internet it must be an integral part of the home page, that is, the main page of the internet message or advertisement, and not of the page given as a link or reference to the main page. An advertising message must not create a false impression, among the eleven listed matters, that a device has no adverse effects, that consulting a doctor is unnecessary, that examination or surgery can be avoided, that use guarantees success, that one device is the best, that a device should be used even with no signs of illness, that the health of a non-user will be impaired, that the device is food, a supplement, a cosmetic or a toy, that the device is or will be registered in the following period, that a prescribed device can be replaced by the advertised one, or that the device is harmless because of its natural origin; and it must not set out the price of a device, recommendations of healthcare professionals or scientific workers about its performance, or recommendations or the image of a popular person who could influence its use.

Conditions
  • The warning wording is prescribed verbatim by the rulebook and must be reproduced as such in the advertising message.
  • Advertising to the general public may also take the form of giving a free sample, which Articles 12–18 regulate.
Rulebook on more detailed conditions and manner of advertising of medical devices ("Official Gazette of Montenegro", No 042/23 from 19.04.2023) — English text

Montenegrin source (quoted in the original; the English rendering below is from the Ministry's own English text published on the same site, declared as the supporting source). Verbatim Član 6 stav 3: "Upozorenje iz stava 2 tačka 3 ovog člana treba da glasi: \"Prije upotrebe pročitati uputstvo! O namjeni i neželjenim dejstvima medicinskog sredstva posavjetujte se sa doktorom medicine ili farmaceutom\", odnosno za medicinska sredstva namijenjena za upotrebu u stomatologiji: \"Prije upotrebe pročitati uputstvo! O namjeni i neželjenim dejstvima medicinskog sredstva posavjetujte se sa doktorom stomatologije ili farmaceutom.\"." Verbatim Član 7 tačka 9: "je medicinsko sredstvo registrovano ili da će u narednom periodu biti registrovano;". Translation of Član 6 stav 3: "The warning from paragraph 2 item 3 of this Article shall read: 'Read the instructions before use! Consult a doctor of medicine or pharmacist about the purpose and adverse effects of the medical device', i.e. for medical devices intended for use in dentistry: 'Read the instructions before use! Consult a dentist or pharmacist about the purpose and adverse effects of the medical device.'" Translation of Član 7 item 9: "a medical device is, or will be, registered in the following period;".

Advertising a device that is not compliant or not registered is prohibited

advertising.prohibited-for-non-compliant-or-unregistered-devices
Fact-level verified

Advertising a medical device that is not compliant with the technical requirements, that is, that is not registered, is prohibited. Advertising a medical device that is misleading — that describes the disease and treatment successes in a way that leads to self-medication, or that advertises a device in an inappropriate or sensationalist way about its treatment successes by displaying images and the like — is also prohibited, as is advertising devices dispensed at the expense of health insurance. For the protection of public health the Ministry may prescribe other medical devices that may not be advertised, and the Ministry prescribes the detailed conditions and manner of advertising medical devices.

Conditions
  • The Ministry's rulebook under this authorisation is the Rulebook on more detailed conditions and manner of advertising of medical devices (Sl. list CG 042/23).

Montenegrin source. Verbatim stav 2: "Zabranjeno je oglašavanje medicinskog sredstva koje nije usaglašeno sa tehničkim zahtjevima, odnosno koje nije registrovano." Translation: "Advertising a medical device that is not compliant with the technical requirements, i.e. that is not registered, is prohibited." Verbatim stav 5: "Bliže uslove i način oglašavanja medicinskih sredstava propisuje Ministarstvo." Translation: "The Ministry prescribes the detailed conditions and manner of advertising medical devices."

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

Compare countries

Registration decision validity, renewal and the 90-day run-off

renewal.registration-decision-validity-and-extension
Fact-level verified
Statement

The registration decision's validity period cannot be longer than 60 days after the expiry of the conformity document. For Class I devices (other than Class Is and Class Im) and for in vitro diagnostic "other" devices marketed on the manufacturer's own declaration of conformity, the registration decision is issued for five years. A device for which no extension application has been filed may remain on the market at most 90 days after the registration decision expires, and during that period import of the device is prohibited.

Validity Rule

≤ 60 days beyond the conformity document; 5 years for Class I / IVD other

Renewal Required

Yes

Conditions
  • The holder must regularly renew the conformity certificates and other time-limited documents; if validity is not renewed or extended the Institute deletes the device from the register (applicant guide).
  • The extension fee is 50% of the first-registration fee under the fee decision's explanatory note.

Effective from 2024-10-01

Verbatim: "O registraciji medicinskog sredstva Agencija izdaje rješenje čiji rok važenja ne može da bude duži od 60 dana nakon isteka važenja isprave o usaglašenosti. Za medicinska sredstva klase I (osim klase I sterilna (Is) i klase I mjerna (Im)), kao i klase in vitro dijagnostička-Ostala medicinska sredstva, koja su u prometu na osnovu izjave o usaglašenosti izdate od strane proizvođača, rješenje o registraciji medicinskog sredstva izdaje se na period od pet godina. Medicinska sredstva za koja nije podnijeta prijava za produženje registracije, mogu da budu na tržištu najviše 90 dana od dana isteka rješenja o registraciji medicinskog sredstva. U roku iz stava 3 ovog člana, zabranjen je uvoz medicinskog sredstva kome je istekao rješenje o upisu u registar." Source language: Montenegrin.

Authority & regime

Which authority and binding regime govern this product, task, and date?

Compare countries

Competent authority and its delegated tasks

authority.competent-authority-and-delegated-tasks
Fact-level verified
Statement

The competent authority for medical devices is the Institute for Medicines and Medical Devices of Montenegro — CInMED (Institut za ljekove i medicinska sredstva Crne Gore). It keeps the registers of manufacturers, wholesalers, importers, specialised retail outlets and medical devices; authorises imports of unregistered devices; authorises and controls clinical investigations; operates the vigilance system; and decides on classification. These tasks are performed as tasks under delegated (transferred) jurisdiction. The Ministry of Health adopts the implementing regulations and designates/authorises conformity-assessment bodies; the inspection-affairs administration carries out inspection surveillance.

Authority Name

Institut za ljekove i medicinska sredstva Crne Gore (CInMED)

Authority Name En

Institute for Medicines and Medical Devices of Montenegro

Authority Type

Agency Under Delegated Jurisdiction

Effective from 2024-10-01

Original Montenegrin, Član 12 st. 1 (izvod): "Agencija: 1) vrši upis, brisanje i vodi registar proizvođača i pravnih lica koji vrše promet na veliko, uvoz i izvoz medicinskih sredstava ... 2) vrši upis, brisanje i vodi registar medicinskih sredstava koja mogu da budu u prometu u Crnoj Gori; 3) daje odobrenje za uvoz medicinskih sredstava iz člana 66 ovog zakona; ... 5) sprovodi sistem vigilance;" and st. 3: "Poslove iz stava 1 tač. 1 do 7 ovog člana, Agencija vrši kao poslove iz prenešene nadležnosti." Translation: the Agency keeps the registers of manufacturers/persons carrying out wholesale, import and export of medical devices and the register of devices that may be marketed in Montenegro; authorises imports under Art. 66; operates the vigilance system; and performs items 1-7 as delegated tasks. Ministry and inspection competences are in Član 10 and Član 11 of the same law. Source language: Montenegrin. The registered display label "CInMED" is a short form; the institute's own documents use "Institut za ljekove i medicinska sredstva".

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

Compare countries

Amendment of register data before the change is introduced

change.amendment-application-before-introducing-the-change
Fact-level verified
Statement

The entities entered in the register must file an application with the Institute for every amendment or supplement of the register data before introducing the change. The Institute issues the amendment decision within 60 days of submission of a complete application; if the application is incomplete the applicant is given 30 days to remedy it. Amendments that do not affect the safety and performance of the medical device are notified to the Institute and entered in the register without a decision.

Change Control Rule

prior application; 60-day decision; administrative amendments notified

Effective from 2024-10-01

Verbatim: "Subjekti iz člana 40 stav 1 ovog zakona dužni su da Agenciji podnesu prijavu za svaku izmjenu ili dopunu podataka iz registra, prije uvođenja promjene. ... Agencija donosi rješenje o izmjeni, odnosno dopuni registracije u roku od 60 dana od dana podnošenja potpune prijave. Izmjene i dopune registracije koje nemaju uticaja na sigurnost i performanse medicinskog sredstva prijavljuju se Agenciji." Change of the authorised representative is additionally governed by Član 43 (notification without delay, contract between manufacturer and the new representative). Source language: Montenegrin.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

Compare countries

The Agency may accept a clinical-investigation control carried out by an EU member state

clinical-investigation.acceptance-of-eu-investigation-control
Fact-level verified

The Agency may carry out a control of a clinical investigation and also at the sponsor's request, and it may accept a control of the clinical investigation carried out, in accordance with good clinical practice guidelines, by an EU member state or another state with the same requirements for conducting clinical investigations as Montenegro.

Conditions
  • This is an acceptance of a foreign control of the investigation, not a recognition of a foreign approval of the device.

Montenegrin source. Verbatim stav 2: "Agencija može da prihvati kontrolu kliničkog ispitivanja koju je u skladu sa smjernicama Dobre kliničke prakse izvela država članica EU ili druga država sa istim zahtjevima za sprovođenje kliničkih ispitivanja kao u Crnoj Gori." Translation: "The Agency may accept a control of the clinical investigation carried out, in accordance with good clinical practice guidelines, by an EU member state or another state with the same requirements for conducting clinical investigations as in Montenegro."

40-day approval clock, 10-day deficiency notice, 20 days to supplement, clock stops while supplemented

clinical-investigation.approval-clock-and-deficiency-remedy
Fact-level verified

The Agency issues an approval for a clinical investigation within 40 days of receiving a complete application with documentation, including a positive opinion of the Ethics Committee. If the application is incomplete, the Agency notifies the applicant within ten days of receipt that the application must be supplemented, at the latest within 20 days of receipt of the notification. The 40-day and 10-day clocks do not run until the additional documentation is supplied or the additional explanations requested by the Agency are given. If the applicant does not supplement the application within the 20-day period, the Agency rejects the application as incomplete.

Conditions
  • The clock runs from a complete application that includes the Ethics Committee's positive opinion, so the ethics review precedes the Agency's 40-day period in practice.

Montenegrin source. Verbatim stav 1: "Agencija izdaje odobrenje za kliničko ispitivanje u roku od 40 dana od dana prijema potpunog zahtjeva sa dokumentacijom uključujući pozitivno mišljenje Etičkog odbora." Verbatim stav 3: "Rok iz st. 1 i 2 ovog člana ne teče do dostavljanja dodatne dokumentacije ili davanje dodatnih objašnjenja na zahtjev Agencije." Verbatim stav 4: "Ako podnosilac zahtjeva ne dopuni zahtjev u roku iz stava 2 ovog člana, Agencija će odbiti zahtjev kao nepotpun." Translation of stav 1: "The Agency issues the approval for a clinical investigation within 40 days of the day of receipt of a complete application with documentation, including the positive opinion of the Ethics Committee." Translation of stav 3: "The period from paragraphs 1 and 2 of this Article does not run until the additional documentation is submitted or additional explanations are given at the Agency's request." Translation of stav 4: "If the applicant does not supplement the application within the period from paragraph 2 of this Article, the Agency shall reject the application as incomplete."

Clinical investigations follow good clinical practice and ISO 14155

clinical-investigation.good-clinical-practice-iso-14155
Fact-level verified

A clinical investigation is carried out in accordance with the guidelines of good clinical practice in clinical investigation, that is, the World Standards Organization standard for clinical investigations of medical devices (ISO 14155). The safety and performance of an in vitro diagnostic medical device are assessed on the basis of clinical performance studies. The good clinical practice guidelines are published on the website of the Ministry and of the Agency.

Conditions
  • For IVDs the assessment route named is the clinical performance study rather than a clinical investigation.

Montenegrin source. Verbatim: "Kliničko ispitivanje se obavlja u skladu sa smjernicama Dobre kliničke prakse u kliničkom ispitivanju, odnosno standardom za klinička ispitivanja medicinskih sredstava Svjetske organizacije za standardizaciju (ISO 14155)." Translation: "A clinical investigation is carried out in accordance with the guidelines of Good Clinical Practice in clinical investigation, i.e. the standard for clinical investigations of medical devices of the World Standards Organization (ISO 14155)."

Post-market non-interventional study: notification only, receipt confirmed within 15 days

clinical-investigation.post-market-non-interventional-study-notification
Fact-level verified

A sponsor must notify the Agency of the conduct of a post-market non-interventional clinical investigation. For such an investigation no approval of the Agency is required; the Agency issues a confirmation of receipt of the notification within 15 days of its receipt.

Conditions
  • Notification-only route: no Agency approval, but the Agency still issues a receipt confirmation within 15 days.

Montenegrin source. Verbatim: "Sponzor je dužan da prijavi Agenciji sprovođenje postmarketinškog neintervencijskog kliničkog ispitivanja. Za kliničko ispitivanje iz stava 1 ovog člana nije potrebno odobrenje Agencije. Agencija izdaje potvrdu o prijemu prijave iz stava 1 ovog člana u roku od 15 dana od dana njenog prijema." Translation: "The sponsor is obliged to notify the Agency of the conduct of a post-market non-interventional clinical investigation. For the clinical investigation from paragraph 1 of this Article no approval of the Agency is required. The Agency issues a confirmation of receipt of the notification from paragraph 1 of this Article within 15 days of the day of its receipt."

Only an Agency-approved sponsor may run an investigation; a non-resident sponsor needs a local representative

clinical-investigation.sponsor-approval-and-local-representative
Fact-level verified

A clinical investigation may be carried out by a sponsor that holds the Agency's approval, and must be carried out in a healthcare institution at the sponsor's expense. A sponsor that has no seat, residence or habitual residence in Montenegro must have a representative in Montenegro who is responsible for the sponsor's affairs in the approval and conduct of the clinical investigation in Montenegro.

Conditions
  • The investigation itself must be conducted in a healthcare institution; a sponsor cannot run it from a non-clinical site.

Montenegrin source. Verbatim stav 1: "Kliničko ispitivanje može da obavlja sponzor koji ima odobrenje Agencije." Verbatim stav 3: "Sponzor koji nema sjedište, odnosno boravak ili prebivalište u Crnoj Gori mora da ima predstavnika u Crnoj Gori, koji je odgovoran za poslove sponzora u postupcima odobravanja i sprovođenja kliničkog ispitivanja u Crnoj Gori." Translation of stav 1: "A clinical investigation may be carried out by a sponsor that has the Agency's approval." Translation of stav 3: "A sponsor that has no seat, i.e. residence or habitual residence in Montenegro, must have a representative in Montenegro, who is responsible for the sponsor's affairs in the procedures for approval and conduct of the clinical investigation in Montenegro."

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

Compare countries

Products excluded from the Law on Medical Devices

scope.products-excluded-from-the-law
Fact-level verified
Statement

The Law on Medical Devices does not apply to medicines; cosmetic products; human blood, blood products, plasma or blood cells of human origin, or products containing them at the time of placing on the market, other than the products covered by Art. 2(4); transplants, tissues or cells of human origin and products containing or derived from them, other than the products covered by Art. 2(4); or transplants, tissues or cells of animal origin, unless the medical device is manufactured or made from non-viable animal tissue or from a product made from non-viable animal tissue. Its provisions do apply to in vitro diagnostic medical devices made of tissues, cells or other substances of human origin, and to accessories of medical devices.

Exclusions
  • medicines
  • cosmetic products
  • human blood and blood products
  • human transplants, tissues and cells
  • animal transplants, tissues and cells (unless the device is made of non-living animal tissue)

Effective from 2024-10-01

Verbatim: "Odredbe ovog zakona ne primjenjuju se na: 1) ljekove; 2) kozmetičke proizvode; 3) ljudsku krv, krvne proizvode, plazmu ili krvne ćelije ljudskog porijekla ... 4) transplantate, tkiva, ćelije ljudskog porijekla ... i 5) transplantate, tkiva ili ćelije životinjskog porijekla, osim ako je medicinsko sredstvo proizvedeno ili izrađeno od neživog životinjskog tkiva ..." Source language: Montenegrin.

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

Compare countries

Documents accompanying a device registration or renewal application

dossier.registration-dossier-components
Fact-level verified
Statement

An application to register (or to renew the registration of) a medical device is filed on the prescribed form together with: (1) the number of the registration decision of a manufacturer that has no seat, residence or habitual residence in Montenegro; (2) the declaration of conformity; (3) the conformity certificate; (4) an insurance policy against harmful consequences that may arise from use of the device; (5) the original instructions for use issued by the manufacturer in English, together with a translation into Montenegrin and the languages in official use in Montenegro, certified by a doctor of medicine or of dentistry of the appropriate speciality; (6) the proposed outer packaging and label for Montenegro; and (7) any other documentation the Institute requests under the Law. Class I (general medical devices), the remaining in vitro diagnostic medical devices, and class A in vitro diagnostic medical devices are exempt from the conformity certificate. For manufacturers outside the European Union a free-sale certificate, or a certificate issued by a body authorised for ISO 13485, is additionally filed. Documentation is filed on paper or electronically, in Montenegrin or English, in the original or as a copy signed or certified in accordance with the law. On a renewal application the documentation already filed at registration need not be resubmitted if it has not changed, in which case the applicant files the manufacturer's statement that the documentation is unchanged.

Class IAnd Some Ivd Exemption

Class I (general medical devices), other in vitro diagnostic medical devices, and class A in vitro diagnostic medical devices: no conformity certificate is filed.

Non Eu Manufacturers

For manufacturers outside the European Union, in addition to the above, a free-sale certificate or a certificate issued by a body authorised for ISO 13485 is filed.

Renewal Delta

On renewal, unchanged documentation already filed at registration need not be resubmitted; the applicant instead files the manufacturer's statement that the documentation is unchanged.

Conditions
  • The class exemptions turn on the device class, not on the manufacturer's location.
  • The insurance policy under item 4 and the certified IFU translation under item 5 must be in place before filing; the translation must be certified by a specialist doctor of medicine or dentistry.

Effective from 2026-03-18

Montenegrin source. What this round verified that round 204 could not: round 204 held this dimension only as a source-backed partial against the Institute's guidance summary; this round read the rulebook article itself and can now state the item-by-item list, the class exemptions, the non-EU addition and the renewal delta on the instrument's own text. Translation: "Along with the application for registration, i.e. renewal of the registration period of a medical device, the following is submitted: 1) the number of the registration decision of a manufacturer that has no seat or residence, i.e. habitual residence in Montenegro; 2) declaration of conformity; 3) conformity certificate; 4) insurance policy against harmful consequences that may arise during use of the medical device; 5) the original instructions for use of the medical device issued by the manufacturer in the English language, as well as a translation of those instructions into the Montenegrin language and the languages in official use in Montenegro, certified by a doctor of medicine, i.e. dentistry of the appropriate speciality; 6) proposed outer packaging and label for Montenegro; 7) other documentation at the request of the Institute, in accordance with the Law. By way of exception from paragraph 1 item 3 of this Article, for the registration, i.e. renewal of the registration period, of a medical device of class I (general medical devices), other in vitro diagnostic medical devices and in vitro diagnostic medical devices of class A, no conformity certificate is submitted. For manufacturers outside the European Union, in addition to the documentation from paragraph 1 of this Article, a Free Sale Certificate or a certificate issued by a body authorised for ISO 13485 is also submitted. The documentation from paragraph 1 of this Article is submitted in paper or electronic form, in the Montenegrin or English language, in the original or in a copy signed, i.e. certified in accordance with the law. When submitting an application for renewal of the registration period of a medical device, it is not necessary to submit the documentation submitted at registration of that medical device, if the documentation has not changed. In the case from paragraph 5 of this Article, the applicant submits the manufacturer's statement that the documentation has not changed."

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

Compare countries

Local authorised representative and responsible persons

operator.authorized-representative-and-responsible-persons
Fact-level verified
Statement

The registration application must be filed by a manufacturer seated or residing in Montenegro or its authorised representative, and for a manufacturer without seat, stay or residence in Montenegro by that manufacturer's authorised representative. The applicant must employ a person responsible for documentation and a person responsible for vigilance, and must be permanently available. The documentation-responsible person must hold a health, technical or law degree; the vigilance-responsible person must hold a health or technical degree depending on the type of device, plus additional education in vigilance. The applicant is responsible for the credibility of the documentation in the registration procedure.

Local Agent Required

Yes

Local Agent Role

ovlašćeni predstavnik (authorised representative) established in Montenegro

Effective from 2024-10-01

Verbatim: "Prijavu za registraciju medicinskog sredstva prije stavljanja u promet, odnosno upotrebu dužan je da podnese: 1) proizvođač sa sjedištem ili boravkom, odnosno prebivalištem u Crnoj Gori, odnosno njegov ovlašćeni predstavnik; 2) za proizvođača koji nema sjedište ili boravak, odnosno prebivalište u Crnoj Gori njegov ovlašćeni predstavnik. Podnosilac prijave ... mora da ima zaposleno lice koje je odgovorno za dokumentaciju i zaposleno lice koje je odgovorno za vigilancu, i mora da bude stalno dostupno." Source language: Montenegrin.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

Compare countries

Importer's verification duties before placing on the market

import.conditions-before-placing-imported-device-on-market
Fact-level verified
Statement

An importer of a medical device from a non-EU country may place on the market only a device for which conformity assessment has been carried out under the Law. Before placing the device on the market the importer must ensure that: the manufacturer carried out the conformity-assessment procedure; the manufacturer authorised an authorised representative under the Law; the manufacturer prepared the declaration of conformity and technical documentation; the manufacturer assigned a UDI or bar code, where applicable; the device bears the conformity marking; and the device is labelled under the Law and accompanied by the instructions for use and the declaration of conformity.

Udi Required

Yes

Effective from 2024-10-01

Verbatim: "Uvoznik medicinskog sredstva iz država koje nijesu članice EU može da stavi u promet samo medicinsko sredstvo za koje je izvršeno ocjenjivanje usaglašenosti u skladu sa ovim zakonom. Prije stavljanja medicinskog sredstva u promet, uvoznik je dužan da obezbijedi da je: 1) proizvođač sproveo odgovarajući postupak ocjenjivanja usaglašenosti ... 4) proizvođač dodijelio medicinskom sredstvu jedinstveni identifikacioni broj medicinskog sredstva (UDI), odnosno bar kod, ako je primjenljivo; 5) medicinsko sredstvo označeno znakom usaglašenosti ... 6) medicinsko sredstvo obilježeno u skladu sa ovim zakonom i praćeno uputstvom za upotrebu i deklaracijom o usaglašenosti." Source language: Montenegrin.

Import and export only by persons entered in the importer register

import.importer-and-wholesaler-registration
Fact-level verified
Statement

Import and export of medical devices may be carried out by domestic and foreign legal and natural persons entered in the register of importers kept by the Institute. The registration decision covers the device, the manufacturer, the legal person carrying out wholesale and retail trade and the importer.

Import Establishment Required

Yes

Effective from 2024-10-01

Verbatim: "Uvozom i izvozom medicinskih sredstava mogu da se bave domaća i strana pravna lica i fizička lica koja su upisana u registar uvoznika koji vodi Agencija." Source language: Montenegrin.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Instructions for use in Montenegrin with certified translation

label.instructions-for-use-language-and-certified-translation
Fact-level verified
Statement

The instructions for use of a medical device must be written in the Montenegrin language and in the languages in official use in Montenegro, in line with the registration, and must correspond in full to the original manufacturer's text and be prepared so as to be understandable to the patient and user. The registration dossier must contain the original English-language instructions for use issued by the manufacturer and a translation into Montenegrin confirmed by a medical doctor or dentist of the appropriate specialty.

Language Requirement

Montenegrin + languages in official use in Montenegro

Conditions
  • The instructions for use are exceptionally not required for Class I or IIa devices, in justified cases, and for in vitro diagnostic devices if they can be used safely without them (Law Art. 86(3)).

Effective from 2024-10-01

Verbatim: "Uputstvo za upotrebu medicinskog sredstva mora da bude napisano na crnogorskom jeziku i jezicima koji su u službenoj upotrebi u Crnoj Gori u skladu sa registracijom, i mora u potpunosti da odgovara originalnom tekstu uputstva proizvođača i pripremljeno na način razumljiv pacijentu i korisniku." The certified-translation requirement is Pravilnik Član 10 st. 1 tač. 5 and the applicant guide item 9: "Prevod originalnog uputstva za upotrebu na crnogorski jezik i jezike koji su u službenoj upotrebi u Crnoj Gori potvrđen od strane doktora medicine, odnosno stomatologije odgovarajuće specijalnosti". Source language: Montenegrin.

Outer packaging labelling and the Montenegro label

label.outer-packaging-and-montenegro-specific-label
Fact-level verified
Statement

The outer and inner packaging of a medical device for professional use must be labelled in Montenegrin and in the languages in official use in Montenegro; exceptionally the outer packaging of a professional-use device may be labelled in English with a label containing all the information on the original packaging. The outer packaging of a device the patient uses independently must be labelled in Montenegrin and the official-use languages, or may carry a label containing all the information on the original packaging. The name of the manufacturer or its authorised representative and the number of the device registration decision must appear on the outer packaging, and may be on a label affixed to the outer packaging; affixing that label is not considered part of the manufacturing process.

Language Requirement

Montenegrin + languages in official use in Montenegro (English permitted for professional-use outer packaging with a full-content label)

Effective from 2024-10-01

Verbatim: "Spoljašnje i unutrašnje pakovanje medicinskog sredstva za profesionalnu upotrebu mora da bude obilježeno na crnogorskom jeziku i jezicima koji su u službenoj upotrebi u Crnoj Gori. Izuzetno od stava 1 ovog člana spoljašnje pakovanje medicinskog sredstva za profesionalnu upotrebu može da bude obilježeno i na engleskom jeziku, sa naljepnicom koja sadrži sve podatke koji se nalaze na originalnom pakovanju. ... Podaci o proizvođaču, odnosno ovlašćenom predstavniku proizvođača medicinskog sredstva i broju rješenja registracije medicinskog sredstva navode se na spoljašnjem pakovanju, i mogu da budu navedeni na naljepnici koja se stavlja na spoljašnje pakovanje medicinskog sredstva. Lijepljenje naljepnice iz stava 4 ovog člana ne smatra se dijelom postupka proizvodnje medicinskog sredstva." Source language: Montenegrin.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

Compare countries

Continuous post-market monitoring by manufacturer or authorised representative

pms.continuous-market-monitoring-by-manufacturer-or-representative
Fact-level verified
Statement

The manufacturer, or the authorised representative, must continuously monitor the medical device on the market in order to identify the need to apply immediately all necessary corrective or preventive measures, keep records of the corrective and preventive measures implemented, and inform the Institute of them.

Pms Owner

manufacturer or authorised representative

Effective from 2024-10-01

Verbatim: "Proizvođač, odnosno ovlašćeni predstavnik dužan je da kontinuirano vrši praćenje medicinskog sredstva na tržištu u cilju identifikovanja potrebe da se odmah primijene sve potrebne korektivne ili preventivne mjere i da o sprovedenim korektivnim i preventivnim mjerama vodi evidenciju, i da o tome obavještava Agenciju." Source language: Montenegrin.

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

Prescribed application forms, one per device class, annexed to the registration rulebook

forms.application-forms-published-on-the-institute-website
Fact-level verified
Statement

An application to register a medical device, to renew its registration period, to amend or supplement registration data, or to delete a device from the register of medical devices, is filed on the prescribed form for the class: for class I medical devices, Form 1 (Obrazac 1); for class IIa, IIb and III medical devices, Form 2 (Obrazac 2); for in vitro diagnostic medical devices, Form 3 (Obrazac 3); and for active implantable medical devices (AIMD), Form 4 (Obrazac 4). The forms are set out in the Annex, which forms an integral part of the rulebook.

Forms By Class
I

Obrazac 1

IIa/IIb/III

Obrazac 2

Ivd

Obrazac 3

Aimd

Obrazac 4

Annex Status

The forms are given in the Annex, which forms an integral part of the rulebook.

Conditions
  • The forms are given in the Annex to the rulebook (Član 9 st. 2) and are also published as separate downloads on the Institute's registration page (each 'ažurirano 28.11.2022'), alongside the applicant guide of 18.03.2026.

Effective from 2026-03-18

Montenegrin source. What this round verified that round 204 could not: round 204 recorded that the Institute publishes guidance and forms on its registration page; this round read the rulebook article that prescribes the forms themselves and ties each form to a device class. Translation: "The application for registration, renewal of the registration period, amendments, i.e. supplements to registration data and deletion of a medical device from the register of medical devices is submitted on the appropriate form, as follows: 1) for medical devices of class I — Form 1; 2) for medical devices of class IIa, IIb and III — Form 2; 3) for in vitro diagnostic medical devices — Form 3; 4) for active implantable medical devices (AIMD) — Form 4. The forms from paragraph 1 of this Article are given in the Annex, which forms an integral part of this Rulebook."

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

Compare countries

Health-inspection powers over GMP, GLP and GDP documentation and their application

qms.inspection-powers-over-gmp-glp-gdp-documentation
Fact-level verified

In carrying out official controls the health inspector is empowered and obliged to review the general and individual acts, records, contracts, technical documentation and other documentation relating to the production, trade, labelling, declaration of conformity, testing and quality control of medical devices, as well as the documentation relating to the application of good manufacturing practice, good laboratory practice and good distribution practice; and to carry out a direct inspection of the application of good manufacturing practice and good distribution practice, as well as of the standard and operating procedures in those fields. The same article also empowers the inspector to inspect employees' identity documents, hear and take statements from responsible and interested persons, inspect business premises, facilities, installations, devices and equipment, inspect medical devices, their labelling, conformity mark, instructions for use and expiry dates, take copies of documents, take samples for quality verification, and photograph or record data for the purpose of gathering evidence.

Conditions
  • The good-practice guidelines reviewed are GMP, GLP and GDP.

Montenegrin source. Verbatim item 1: "pregleda opšte i pojedinačne akte, evidencije, ugovore, tehničku dokumentaciju i drugu dokumentaciju koja se odnosi na proizvodnju, promet, obilježavanje, deklaracija o usaglašenosti medicinskog sredstva (ispravom o usaglašenosti), ispitivanje i kontrolu kvaliteta medicinskih sredstava, kao i dokumentaciju koja se odnosi na primjenu smjernica Dobre proizvođačke prakse, Dobre laboratorijske prakse i Dobre prakse u distribuciji." Verbatim item 2: "izvrši neposredni uvid u primjenu smjernica Dobre proizvođačke prakse, i Dobre prakse u distribuciji, kao i standardnih i operativnih postupaka iz tih oblasti." Translation of item 1: "reviews the general and individual acts, records, contracts, technical documentation and other documentation relating to the production, trade, labelling, declaration of conformity of the medical device, testing and quality control of medical devices, as well as the documentation relating to the application of the guidelines of Good Manufacturing Practice, Good Laboratory Practice and Good Distribution Practice." Translation of item 2: "carries out a direct inspection of the application of the guidelines of Good Manufacturing Practice and Good Distribution Practice, as well as of the standard and operating procedures in those fields."

Non-EU manufacturers document their quality system with an ISO 13485 certificate or a free-sale certificate

qms.iso-13485-certificate-accepted-for-non-eu-manufacturers
Fact-level verified

A manufacturer outside the European Union applying to register a medical device must file, in addition to the standard dossier, a free-sale certificate or a certificate issued by a body authorised for ISO 13485. The ISO 13485 certificate is thus the quality-system evidence the Montenegrin registration route accepts from a non-EU manufacturer.

Conditions
  • This is the registration-dossier limb of the quality-system requirement; the Law's own quality-assurance obligation (Član 51) is evidenced by a certificate from an authorised body without naming the standard.

Montenegrin source. Verbatim: "Za proizvođače van Evropske unije, pored dokumentacije iz stava 1 ovog člana podnosi se i Sertifikat za slobodnu prodaju ili sertifikat izdat od strane ovlašćenog tijela ISO 13485." Translation: "For manufacturers outside the European Union, in addition to the documentation from paragraph 1 of this Article, a Free Sale Certificate or a certificate issued by a body authorised for ISO 13485 is also submitted."

Manufacture must run under a quality-assurance system the manufacturer proves by certificate

qms.manufacturer-quality-assurance-system-certificate
Fact-level verified

A manufacturer must manufacture medical devices in accordance with the essential requirements and the decision issued by the Agency, and that manufacture is carried out under an established quality-assurance system for the manufacture of medical devices, which the manufacturer proves by a certificate issued by an authorised body. A manufacturer that does not have that quality-assurance system established must establish it in accordance with the Law.

Conditions
  • The quality-assurance obligation is on the manufacturer and is evidenced by a certificate from an authorised body; the Law does not itself name a standard number here (ISO 13485 appears in the registration rulebook for non-EU manufacturers).

Montenegrin source. Translation: "The manufacture of medical devices is carried out in accordance with the established quality-assurance system of medical device manufacture, which the manufacturer proves by a certificate issued by an authorised body. If the manufacturer does not have the quality-assurance system from paragraph 1 of this Article established, it is obliged to establish it in accordance with this Law."

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

On a health risk the Agency proposes suspension, prohibition of trade or withdrawal to the health inspection

recall.agency-proposes-suspension-prohibition-or-withdrawal
Fact-level verified

If the Agency establishes that a medical device conforming to the essential requirements, or a device made to order for a particular patient, when correctly installed, maintained and used in accordance with its intended purpose, may endanger the health or safety of a patient, user or other person, it proposes to the health inspection that trade in or use of the device be suspended or prohibited, or that the device be withdrawn from the market in accordance with the Law and with the law governing inspection supervision. The health inspection must notify the Ministry and the Agency of the measures taken without delay.

Conditions
  • The Agency's instrument is a proposal; the coercive act is the health inspection's.

Montenegrin source. Verbatim stav 1 in part: "Agencija ... predlaže zdravstvenoj inspekciji da obustavi, zabrani promet ili upotrebu medicinskog sredstva, ili da naloži da se povuče medicinsko sredstvo sa tržišta u skladu sa ovim zakonom i zakonom kojim se uređuje inspekcijski nadzor." Translation of stav 1 in part: "the Agency ... proposes to the health inspection that it suspend, prohibit trade in or use of the medical device, or that it order the medical device to be withdrawn from the market in accordance with this Law and with the law governing inspection supervision."

The Agency publishes on its website the measures taken for a serious risk a device poses

recall.agency-publishes-measures-for-serious-risks
Fact-level verified

The Agency publishes on its website the notification of the measures and activities undertaken in connection with a serious risk that a medical device poses to public health and to the safety of users. The Ministry prescribes in more detail the conditions for the procedure of suspension or withdrawal of a medical device from trade, as well as the periods and manner of notification of suspension and withdrawal.

Conditions
  • The publication duty is on the Agency; the detailed procedure and notification periods are left to a Ministry instrument.

Montenegrin source. Verbatim stav 1: "Obavještenje o mjerama i aktivnostima koje se preduzimaju u vezi sa ozbiljnim rizikom koji medicinsko sredstvo predstavlja za javno zdravlje i bezbjednost korisnika Agencija objavljuje na svojoj internet stranici." Translation: "The Agency publishes on its website the notification of the measures and activities undertaken in connection with the serious risk that a medical device represents for public health and the safety of users."

The health inspection must prohibit trade and order withdrawal on the listed grounds

recall.inspection-must-prohibit-trade-and-order-withdrawal
Fact-level verified

The health inspection is obliged to prohibit trade and order the withdrawal of a medical device, or a particular batch of a medical device, from the market in the cases set out in Article 7 of the Law and also where: the device is harmful under normal conditions of use; it does not meet the performance requirements; the risk-benefit ratio is unfavourable under the approved conditions of use; its qualitative and quantitative composition does not correspond to what is declared; the prescribed conformity-assessment procedures were not carried out by a notified body; or in other cases where the device is on the market contrary to the conditions prescribed by the Law. Most of those grounds operate on a proposal of the Agency or on a notification received from a notified body.

Conditions
  • The power is the health inspection's, on the Agency's proposal; the Agency itself proposes the measure rather than ordering it.
  • Article 133(2) also allows the inspection to order withdrawal on a notification received through the EU's rapid information exchange system for unsafe products, from an EEA state or a state with which the EU has a mutual-recognition agreement, or from the inspectorate cooperation network (PIC/S) — the Law's one EU-facing recall channel.

Montenegrin source. Verbatim stav 1: "Zdravstvena inspekcija dužna je da zabrani promet i naredi da se medicinsko sredstvo ili određena serija medicinskog sredstva povuče sa tržišta u slučajevima iz člana 7 ovog zakona kao i: 1) ako je određeno medicinsko sredstvo štetno pri uobičajenim uslovima primjene na predlog Agencije ili na osnovu obavještenja dobijenog od imenovanog tijela; 2) ako ne ispunjava performanse, na predlog Agencije ili na osnovu obavještenja dobijenog od imenovanog tijela; 3) ako odnos rizika i koristi nije povoljan pri odobrenim uslovima primjene, na predlog Agencije; 4) ako njegov kvalitativni i kvantitativni sastav ne odgovara deklarisanom; 5) ako propisani postupci ocjenjivanja usaglašenosti nijesu sprovedeni od strane imenovanog tijela; i 6) u drugim slučajevima kada je medicinsko sredstvo na tržištu suprotno uslovima propisanim ovim zakonom." Translation: "The health inspection is obliged to prohibit trade and to order that the medical device or a particular batch of the medical device be withdrawn from the market in the cases from Article 7 of this Law and also: 1) if a particular medical device is harmful under usual conditions of use, on a proposal of the Agency or on the basis of a notification received from a notified body; 2) if it does not meet the performance, on a proposal of the Agency or on the basis of a notification received from a notified body; 3) if the risk-benefit ratio is not favourable under the approved conditions of use, on a proposal of the Agency; 4) if its qualitative and quantitative composition does not correspond to the declared one; 5) if the prescribed conformity assessment procedures were not carried out by a notified body; and 6) in other cases where the medical device is on the market contrary to the conditions prescribed by this Law." Note on the market's EU status: Montenegro is an EU candidate and does not yet apply the MDR; Article 133(2) is the Law's own EU-facing recall channel.

A decision to withdraw a device or a batch from the market must be notified to the Agency without delay

recall.manufacturer-wholesaler-importer-must-notify-the-agency-without-delay
Fact-level verified

If the manufacturer, the wholesaler or the importer decides to withdraw a medical device, or a particular batch of a medical device, from the market, it is obliged to notify the Agency of that without delay. Responsibility for withdrawing a device from the market and for taking measures to prevent it being placed on the market lies with the importer of that device, as well as with the person responsible for vigilance at the importer.

Conditions
  • The notification duty is triggered by the operator's own withdrawal decision; the Agency-proposed suspension or prohibition route runs separately through the health inspection.

Montenegrin source. Verbatim stav 2: "Ako proizvođač, veleprodaja ili uvoznik donese odluku da povuče sa tržišta medicinsko sredstvo ili određenu seriju medicinskog sredstva dužan je da o tome, bez odlaganja obavijesti Agenciju." Translation: "If the manufacturer, wholesale or importer takes a decision to withdraw from the market a medical device or a particular batch of a medical device, it is obliged to notify the Agency thereof without delay."

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Registration is filed on a form prescribed by risk class

registration.application-forms-by-risk-class
Fact-level verified
Statement

The application for registration, for extension of the registration period, for amendment/supplement of registration data and for deletion from the register of medical devices is filed on the prescribed form: Form 1 (Obrazac 1) for Class I devices, Form 2 (Obrazac 2) for Class IIa, IIb and III devices, Form 3 (Obrazac 3) for in vitro diagnostic medical devices, and Form 4 (Obrazac 4) for active implantable medical devices (AIMD).

Forms
  • Obrazac 1 — klasa I
  • Obrazac 2 — klasa IIa, IIb, III
  • Obrazac 3 — IVD
  • Obrazac 4 — AIMD

Effective from 2022-08-10

Verbatim: "Prijava za registraciju, produžetak perioda registracije, izmjene, odnosno dopune podataka o registraciji i brisanje medicinskog sredstva iz registra medicinskih sredstava podnosi se na odgovarajućem obrascu, i to: 1) za medicinska sredstva klase I - Obrazac 1; 2) za medicinska sredstva klase IIa, IIb i III - Obrazac 2; 3) za in vitro dijagnostička medicinska sredstva - Obrazac 3; 4) za aktivna implantabilna medicinska sredstva (AIMD) - Obrazac 4." Source language: Montenegrin.

90-day registration deadline and who is entered in the register

registration.ninety-day-registration-deadline
Fact-level verified
Statement

Within 90 days of the submission of complete documentation the Institute enters in the register: the medical device, the manufacturer, the legal person carrying out wholesale and retail trade in the device, and the importer. If the application is incomplete the Institute invites the applicant in writing to remedy the deficiencies within 30 days, and the 90-day period does not run until the requested data and documents are supplied.

Review Clock Days

90

Effective from 2024-10-01

Verbatim: "Agencija upisuje u registar: medicinsko sredstvo, proizvođača, pravno lice koje se bavi prometom na veliko i prometom na malo medicinskog sredstva i uvoznika, u roku od 90 dana od dana podnošenja potpune dokumentacije." and "Ako prijava za registraciju nije potpuna, Agencija pisanim putem obavještava podnosioca prijave da u roku od 30 dana otkloni nedostatke ... Rok iz stava 1 ovog člana ne teče do dostavljanja traženih podataka i dokumenata." Source language: Montenegrin.

Registration is formally not a precondition for placing on the market

registration.not-a-precondition-for-placing-on-market
Fact-level verified
Statement

Registration of a medical device under the Law on Medical Devices is not a condition for placing the device on the market or putting it into service (Art. 37(2)).

Source Approval

n/a

Conditions
  • In practice unregistered devices cannot be marketed: Art. 7(1)(2) prohibits the marketing of a device not entered in the register of medical devices, and wholesalers may procure and supply only devices entered in the register (Art. 70-71).
  • Import and export may only be carried out by persons entered in the importer register (Art. 68).

Effective from 2024-10-01

Verbatim: "Registracija medicinskog sredstva u skladu sa ovim zakonom nije uslov za stavljanje medicinskog sredstva u promet, odnosno upotrebu." The caveat in `conditions` is from Član 7 st. 1 tač. 2 ("Zabranjen je promet medicinskog sredstva: ... 2) koje nije upisano u registar medicinskih sredstava u skladu sa ovim zakonom") and Član 70-71 of the same law; the two provisions pull in opposite directions and both are quoted so a reader can see the tension. Source language: Montenegrin.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

Montenegro approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for Montenegro (8 records)

MontenegroEU conformity assessment

Prior approval / evidence record

Direct recognition is limited to EU notified-body documents and CE marking

reliance.direct-recognition-limited-to-eu-notified-body-documents
Fact-level verified
Statement

A foreign document, or the CE mark, is directly recognised in Montenegro if it was issued by a notified body of the European Union, or if it was affixed to the device in accordance with the harmonised technical regulation of the European Union. Direct recognition is conditional on the foreign technical regulation providing at least the same level of protection of safety, health, environment and consumers as the corresponding Montenegrin technical regulation, and on the requirements the foreign conformity-assessment body has to meet not being laxer than the Montenegrin ones. A recognition decision is valid until the foreign document expires, or at most three years from its issue if no expiry is stated.

Source Approval

EU CE Marking issued by an EU notified body (prijavljeno tijelo) under the EU harmonised technical regulation

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The recognition request must name the foreign document/CE mark, the foreign technical regulation under which it was issued, the conformity-assessment body that issued it, and the state that notified that body (Rulebook Art. 7).
  • Validity: until the foreign document expires; at most three years if the foreign document states no expiry (Rulebook Art. 8(3)).

Effective from 2022-08-10

Verbatim Član 6: "Inostrana isprava, odnosno CE znak se direktno priznaje u Crnoj Gori ako je izdata od strane prijavljenog tijela Evropske unije, odnosno ako je postavljen na medicinsko sredstvo u skladu sa harmonizovanim tehničkim propisom u Evropskoj uniji." Član 5 st. 1 sets the two equivalence conditions; Član 8 st. 2-3 sets validity. Translation: a foreign document, i.e. the CE mark, is directly recognised in Montenegro if issued by an EU notified body or affixed in accordance with the EU harmonised technical regulation. Source language: Montenegrin.

MontenegroEU conformity assessment

Prior approval / evidence record

Recognition of a foreign conformity document and CE marking

reliance.ce-conformity-document-recognised-in-registration
Fact-level verified
Statement

Recognition of a conformity document and of the CE mark issued by a conformity-assessment body that has no seat in Montenegro is carried out by the Institute within the medical-device registration procedure; exceptionally, the Institute may issue a recognition decision on the request of the manufacturer or its authorised representative.

Source Approval

EU CE Marking / EC certificate of conformity issued by a conformity-assessment body established outside Montenegro (in practice an EU notified body)

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Recognition is a documentary act inside (or alongside) registration — it does not replace the Montenegrin registration decision.
  • Detailed conditions and procedure are set by the Ministry (Rulebook, Sl. list CG 85/22, 126/22).

Effective from 2024-10-01

Verbatim: "Priznavanje isprave o usaglašenosti i CE znaka iz st. 2 i 3 ovog člana koje je izdalo tijelo za ocjenjivanje usaglašenosti koje nema sjedište u Crnoj Gori, vrši Agencija u postupku registracije medicinskog sredstva. Izuzetno od stava 4 ovog člana, Agencija može da izda rješenje o priznavanju inostrane isprave ili CE znaka i na zahtjev proizvođača, odnosno ovlašćenog predstavnika proizvođača." Translation: recognition of a conformity document and CE mark issued by a conformity-assessment body not seated in Montenegro is done by the Agency in the registration procedure; exceptionally the Agency may issue a recognition decision on the manufacturer's/authorised representative's request. Source language: Montenegrin.

MontenegroISO

Prior approval / evidence record

Origin-country evidence required for manufacturers outside the EU

reliance.origin-country-free-sale-certificate-or-iso-13485
Fact-level verified
Statement

For manufacturers outside the European Union the registration dossier must, in addition to the standard documentation, contain a free sale certificate or a certificate issued by an authorised body under ISO 13485. The applicant guide states the same alternative as: an ISO 13485 quality-management certificate, or proof that the device is marketed in the manufacturer's own country or in an EEA member state (free sale certificate).

Source Approval

Free sale certificate from the manufacturer's own country or an EEA member state; or an ISO 13485 certificate — no named national approval is required

Edge Type

Origin Country Evidence

Market Access Strength

Evidence Only

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • This is documentary evidence supporting an already-CE-marked device; it does not open a separate route for a non-CE device.

Effective from 2022-08-10

Verbatim: "Za proizvođače van Evropske unije, pored dokumentacije iz stava 1 ovog člana podnosi se i Sertifikat za slobodnu prodaju ili sertifikat izdat od strane ovlašćenog tijela ISO 13485." Translation: for manufacturers outside the EU, in addition to the documentation in paragraph 1, a free sale certificate or an ISO 13485 certificate is submitted. Corroborated by res-me-cinmed-guide-2026 item 11. Source language: Montenegrin.

MontenegroEU conformity assessment

Prior approval / evidence record

MDR-compliant declaration of conformity required; MDD declarations no longer valid

reliance.mdr-compliant-declaration-of-conformity-required
Fact-level verified
Statement

For a Class I device that keeps the same risk class under MDR (EU) 2017/745 and therefore needs no notified body, the Institute accepts placement on the Montenegrin market only if the device is compliant with MDR (EU) 2017/745. A declaration of conformity issued under Directives 93/42/EEC or 90/385/EEC is not considered a valid document, and such devices may not be distributed in Montenegro.

Source Approval

EU CE Marking under MDR (EU) 2017/745

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • Class I devices that rise to a higher risk class under MDR and hold an MDD/AIMD declaration of conformity issued before 26 May 2021 may be placed on the market until 31 December 2028, subject to the MDR Art. 120 conditions (notified-body application by 26 May 2024, Annex VII agreement by 26 September 2024, ISO 13485 QMS certificate).

Effective from 2025-06-18

Verbatim: "Medicinska sredstva I klase rizika koja su klasifikovana kao medicinska sredstva I klase rizika i u skladu sa zahtjevima EU Regulative 2017/745 ... nakon 26.05.2021. godine mogu se staviti na tržište i u upotrebu na teritoriji Crne Gore samo ukoliko su usaglašena sa zahtjevima EU Regulative 2017/745. Ukoliko naprijed navedena medicinska sredstva ne posjeduju Deklaraciju o usaglašenosti koja je usklađena sa EU Regulativom 2017/745 neće moći da se distribuiraju u Crnoj Gori, a Institut Deklaracije o usaglašenosti koje su izdate u skladu sa Direktivama 93/42 EEC i 90/385 EEC ne može smatrati validnim dokumentom." Source language: Montenegrin. Notice is based on MDR Art. 120 and the Law on Medical Devices; updated 18.06.2025.

MontenegroUS FDA

Prior approval / evidence record

US FDA 510(k) clearance or PMA approval

Authority

US FDA 510(k) clearance or PMA approval

Accepted

No

Benefit

No substitute for the conformity documents recognised by CInMED; useful only as supporting technical documentation in the file.

Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 37, 38 i 40Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 66 i 67Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 94 i 101Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 41, 42 i 44CInMED — Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva, updated 18 March 2026

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MontenegroEU conformity assessment

Prior approval / evidence record

IVDR-compliant declaration of conformity required for in vitro diagnostic devices

reliance.ivdr-compliant-declaration-of-conformity-required
Fact-level verified
Statement

For in vitro diagnostic devices that were "other IVD" under Directive 98/79/EC and are Class A under IVDR (EU) 2017/746 — i.e. needing no notified body — a declaration of conformity issued under Directive 98/79/EC is no longer a valid document after 26 May 2022 and will not be recognised by the Institute; the declaration of conformity must comply with IVDR (EU) 2017/746. Legacy IVDD certificates that were valid on 26 May 2022 and not withdrawn may keep devices on the market at the latest until 31 December 2027, subject to the IVDR Art. 110(3) conditions.

Source Approval

EU CE Marking under IVDR (EU) 2017/746

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The Institute's notice relies on IVDR Art. 110(3) as amended by EU 2022/112, EU 2023/607 and EU 2024/1860, and on opinions of the Montenegrin Ministry of Health of 23.11.2022 and 14.12.2023.

Effective from 2025-06-18

Verbatim: "Nakon 26.05.2022. godine, Deklaracija o usaglašenosti izdata u skladu sa zahtjevima Direktive 98/79 EC ne može se smatrati validnim dokumentom, te takva Deklaracija neće biti priznata u postupcima koji se vode pred Institutom za ljekove i medicinska sredstva. Deklaracija o usaglašenosti mora biti u skladu sa zahtjevima Regulative EU 2017/746." and "... in vitro dijagnostičko sredstvo može biti u prometu najkasnije do 31.12.2027. godine". Source language: Montenegrin.

MontenegroEU conformity assessment

Prior approval / evidence record

EU CE marking under Regulation (EU) 2017/745 (MDR)

Authority

EU CE marking under Regulation (EU) 2017/745 (MDR)

Accepted

Yes

Benefit

A declaration of conformity or EC certificate issued by an EU manufacturer or an EU-notified body is recognised as the conformity input in the CInMED registration procedure under the Pravilnik o priznavanju inostranih isprava i CE znaka, and it lowers the fee line for devices that would otherwise be registered without an EU conformity document. It does not remove the national registration, and CInMED no longer accepts declarations issued under the MDD/AIMD that are not aligned with Regulation (EU) 2017/745.

Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 37, 38 i 40Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 66 i 67Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 94 i 101Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 41, 42 i 44CInMED — Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva, updated 18 March 2026

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

MontenegroEU conformity assessment

Prior approval / evidence record

Legacy MDD/AIMD EC certificates recognised only to 2027/2028 deadlines

reliance.legacy-mdd-ec-certificate-transition-deadlines
Fact-level verified
Statement

An EC certificate of conformity issued under the former MDD/AIMD directives that was valid on 26 May 2021 and has not been withdrawn remains valid after the date printed on it only until 31 December 2027 for Class III, implantable Class IIb (with listed exceptions) and AIMD devices, and until 31 December 2028 for the remaining Class IIb, Class IIa and Class Is/Im devices.

Source Approval

EU CE Marking — legacy MDD/AIMD EC certificates (MDR Art. 120 transition)

Edge Type

Abridged Or Recognition Route

Market Access Strength

facilitated

Regulatory Layer

Premarket Review

Local Application Required

Yes

Target Decision Retained

Yes

Conditions
  • The device must still comply with Directives 90/385/EEC and 93/42/EEC, have no significant changes in design or intended purpose and present no unacceptable risk.
  • Manufacturer QMS to MDR Art. 10(9) by 26 May 2024; formal application to a notified body by 26 May 2024; Annex VII written agreement by 26 September 2024.
  • The applicant must file the expired EC certificate, a manufacturer declaration and the notified-body documents with the Institute.

Effective from 2025-06-18

Verbatim: "Ukoliko je Sertifikat o usaglašenosti – EC sertifikat izdat od strane ovlašćenog tijela u skladu sa predhodno važećim direktivama važio na dan 26.05.2021. godine i nije naknadno povučen, ostaće na snazi i nakon datuma isteka navedenog na sertifikatu i to do sljedećih datuma: a. 31.12.2027. godine – za medicinska sredstva III klase rizika, IIb koja su implantabilna (izuzetak su šavovi, klipsevi, zubni ispuni, ortodontski aparati, zubne nadoknade, zavrtnji, klinovi, ploče, žice, igle, kopče i konektori), AIMD medicinska sredstva. b. 31.12.2028. godine – za medicinska sredstva IIb klase rizika koja nijesu obuhvaćena tačkom a., IIa klase rizika i I klase rizika koja se stavljaju na tržište u sterilnom stanju ili su sa mjernom funkcijom." Source language: Montenegrin.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

Authorisation to import unregistered devices

special-access.import-authorisation-for-unregistered-devices
Fact-level verified
Statement

The Institute may authorise the import of medical devices that are not registered where there is an urgent medical need, for the protection of public health, and in the following cases: for research purposes, for clinical investigations, in the event of natural disasters, or other states of emergency. For such a device conformity assessment, or an equivalent assessment of safety and performance, must have been carried out under the Law. The application to the Institute states the name and quantity of the devices, the manufacturer's details, an expert opinion of the responsible person of the health institution for which the devices are imported, and data on the device's compliance. The Institute issues the decision within 30 days of receipt of a complete application.

Review Clock Days

30

Effective from 2024-10-01

Verbatim: "Agencija može da odobri uvoz medicinskih sredstava koja nijesu registrovana u slučaju kada se radi o hitnoj medicinskoj potrebi, za potrebe zaštite javnog zdravlja, kao i u sljedećim slučajevima: 1) za istraživačke svrhe; 2) za klinička ispitivanja; 3) za slučaj elementarnih nepogoda; ili 4) drugih vanrednih stanja. Za medicinsko sredstvo iz stava 1 ovog člana mora da bude izvršeno ocjenjivanje usaglašenosti, odnosno ekvivalentna ocjena sigurnosti i performansi u skladu sa ovim zakonom." The 30-day clock is Član 67 st. 3: "Agencija u roku od 30 dana od dana prijema potpune prijave izdaje rješenje kojim se odobrava ili odbija prijava za uvoz medicinskog sredstva koje nije registrovano." Source language: Montenegrin.

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Change control: 60-day decision clock, 30-day deficiency remedy, notification-only for safety-neutral changes

submission.amendment-deficiency-period-and-decision-clock
Fact-level verified

Operators must file an application with the Agency for every amendment or supplement to the data in the register before introducing the change. If the application to amend or supplement the registration is incomplete, the Agency notifies the applicant in writing to remedy the deficiencies and supply the requested data and documents within 30 days. The Agency issues the decision on the amendment or supplement of the registration within 60 days of the day of submission of the complete application. Amendments and supplements that do not affect the safety and performance of the device are notified to the Agency, and those are entered in the register without a decision being issued, with the applicant being informed. The Agency may verify the stated data and other data relevant to public health and give a negative opinion on the notified amendment or supplement.

Conditions
  • A safety- and performance-neutral change takes the notification route and is entered in the register without a decision, so the 60-day decision clock applies only to changes outside that category.

Montenegrin source. Verbatim stav 2: "Ako prijava za izmjenu i dopunu registracije nije potpuna, Agencija pisanim putem obavještava podnosioca prijave da u roku od 30 dana otkloni nedostatke i dostavi zatražene podatke i dokumente." Verbatim stav 3: "Agencija donosi rješenje o izmjeni, odnosno dopuni registracije u roku od 60 dana od dana podnošenja potpune prijave." Negative search result for the appeal limb of this dimension: the Law on medical devices contains no provision on appeal (žalba), on a second-instance body (drugostepeni organ) or on administrative procedure — a case-insensitive search of the consolidated text for 'žalb', 'drugostepen' and 'upravni postupak' returns nothing. The general remedy is therefore the one in the Zakon o upravnom postupku ("Sl. list CG", br. 56/14, 20/15, 40/16 i 37/17), which CInMED lists alongside the Law on medical devices in its legislation index; that instrument was not retrieved this round, so the second-instance route and its period are not asserted. There is likewise no statutory decision-notice form prescribed for registration: the Law fixes the clock and the effect of an incomplete application, and the registration decision itself is issued under Član 41. Translation of stav 2: "If the application for amendment and supplement of the registration is not complete, the Agency notifies the applicant in writing to remedy the deficiencies within 30 days and submit the requested data and documents." Translation of stav 3: "The Agency issues the decision on the amendment, i.e. supplement of the registration within 60 days of the day of submission of the complete application."

Registration: 90-day entry clock, 30-day deficiency remedy, clock stops while documents are supplied

submission.registration-deficiency-period-and-clock-stop
Fact-level verified

The Agency enters into the register the medical device, the manufacturer, the legal person engaged in wholesale and retail trade in the medical device, and the importer, within 90 days of the day of submission of complete documentation. During the registration procedure the Agency may request from the applicant additional data needed to assess whether the conditions for registration are met. If the registration application is incomplete, the Agency notifies the applicant in writing to remedy the deficiencies and supply the requested data and documents within 30 days, and the 90-day period does not run until the requested data and documents are supplied. The Agency may, within the application procedure, verify the stated data and other data relevant to public health.

Conditions
  • The 90-day period runs only from complete documentation; an incomplete application suspends it rather than restarting it.

Montenegrin source. Verbatim stav 3: "Ako prijava za registraciju nije potpuna, Agencija pisanim putem obavještava podnosioca prijave da u roku od 30 dana otkloni nedostatke i da dostavi tražene podatke i dokumente." Verbatim stav 4: "Rok iz stava 1 ovog člana ne teče do dostavljanja traženih podataka i dokumenata." Translation of stav 3: "If the registration application is not complete, the Agency notifies the applicant in writing to remedy the deficiencies within 30 days and to submit the requested data and documents." Translation of stav 4: "The period from paragraph 1 of this Article does not run until the requested data and documents are submitted."

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Manufacturer keeps a record of the type and quantity of devices sold in Montenegro

traceability.manufacturer-records-devices-sold-in-montenegro
Fact-level verified

A manufacturer must, among the special conditions it has to meet, establish and maintain a post-market surveillance plan for the device — except for a device made to order for a particular patient or intended for clinical investigation — and keep orderly records of non-conforming devices and of devices withdrawn from trade; and it must keep a record of the type and quantity of medical devices sold in Montenegro. It must also have at least one employee responsible for quality and vigilance, and keep the technical documentation and declaration of conformity for at least five years, and for implantable medical devices at least fifteen years.

Conditions
  • The record is of devices sold in Montenegro, so it is a market-specific sales record rather than a general distribution record.

Montenegrin source. Verbatim tačka 13: "vodi evidenciju o vrsti i količini prodatih medicinskih sredstava u Crnoj Gori;". Verbatim tačka 11 in part: "uspostavi i održava plan praćenja medicinskih sredstava poslije stavljanja na tržište, kao i da uredno vodi evidenciju o neusaglašenim i medicinskim sredstvima povučenim iz prometa". Verbatim tačka 7 in part: "čuva tehničku dokumentaciju i izjavu o usaglašenosti nakon stavljanja medicinskog sredstva u promet, najmanje pet godina, a za implatabilna medicinska sredstva, najmanje 15 godina". Translation of tačka 13: "keeps a record of the type and quantity of medical devices sold in Montenegro;". Translation of tačka 11 in part: "establishes and maintains a plan for the surveillance of medical devices after placing on the market, and keeps orderly records of non-conforming and withdrawn medical devices". Translation of tačka 7 in part: "keeps the technical documentation and the declaration of conformity after placing the medical device on the market for at least five years, and for implantable medical devices for at least 15 years".

Specialised retail outlets keep per-package records of devices sold in Montenegro

traceability.specialised-retail-records-by-individual-package
Fact-level verified

A specialised retail outlet may carry on retail trade in medical devices only if it meets the prescribed conditions, one of which is that it keeps a record of the type and quantity of medical devices sold in Montenegro, by individual package; it must also have an employee responsible for the receipt, storage, keeping, sale and dispensing of medical devices, and appropriate premises and equipment. Separately, where it is rational and feasible, the medical device and its components must be marked with the batch number, so that all necessary measures can be taken if potential risks from the device or its components are identified.

Conditions
  • The retail record is finer-grained than the manufacturer's: it is kept 'po pojedinačnim pakovanjima' (by individual package).

Montenegrin source. Verbatim Član 74 stav 1 tačka 3: "vodi evidenciju o vrsti i količini prodatih medicinskih sredstava u Crnoj Gori, po pojedinačnim pakovanjima;". Translation: "keeps a record of the type and quantity of medical devices sold in Montenegro, by individual packages;". Verbatim Član 87 stav 2: "Ako je racionalno i izvodljivo, medicinsko sredstvo i njegovi sastavni djelovi moraju da budu obilježeni brojem serije, da bi se omogućile sve potrebne mjere u slučaju utvrđivanja potencijalnih rizika od medicinskog sredstva i njegovih sastavnih djelova." Translation: "If it is rational and feasible, the medical device and its components must be marked with the batch number, in order to enable all necessary measures in the event of identification of potential risks from the medical device and its components."

Importer must ensure the manufacturer assigned a UDI (or barcode) before placing the device on the market

udi.manufacturer-assigns-udi-before-the-importer-places-it-on-the-market
Fact-level verified

An importer of a medical device from a non-EU state may place on the market only a device for which conformity assessment has been carried out under the Law, and before placing it on the market the importer must ensure that, among other things, the manufacturer has assigned the medical device a unique device identification number (UDI), that is a barcode, where applicable. Additional conditions and the manner of import from non-EU states are prescribed by the Ministry.

Conditions
  • The duty is framed as an importer's verification duty ('obezbijedi da je … proizvođač dodijelio'), with the assignment itself on the manufacturer.
  • Applies to imports from states that are not EU member states.

Montenegrin source. Verbatim item 4: "proizvođač dodijelio medicinskom sredstvu jedinstveni identifikacioni broj medicinskog sredstva (UDI), odnosno bar kod, ako je primjenljivo". Translation: "the manufacturer has assigned to the medical device a unique device identification number (UDI), i.e. a barcode, where applicable". Note on the market's EU status: Montenegro is a candidate country that does not yet apply the MDR; the UDI duty here is the one created by the national Law on medical devices, not a directly applicable Union obligation.

Manufacturer, authorised representative or importer supplies the data for the UDI database and UDI system

udi.operator-supplies-data-for-the-udi-database-and-udi-system
Fact-level verified

The manufacturer, the authorised representative or the importer supplies the information needed for the registration of medical devices and legal persons, as well as the data that are submitted for the UDI database and the UDI system. The same limb appears in the essential requirements for general and active implantable medical devices and for in vitro diagnostic medical devices, and the document of conformity must carry the device's basic UDI-DI as well as an unambiguous reference enabling the identification and traceability of the device.

Conditions
  • The obligation is placed on the manufacturer, the authorised representative or the importer, whichever is the operator supplying the data.
Zakon o medicinskim sredstvima (prečišćeni tekst) — „Službeni list Crne Gore“, br. 024/19 od 22.04.2019 i 084/24 od 06.09.2024

Montenegrin source. Verbatim Član 10: "Proizvođač, ovlašćeni predstavnik, odnosno uvoznik dostavlja informacije potrebne za registraciju medicinskih sredstava i pravnih lica, kao i podatke koji se dostavljaju za UDI bazu podataka i UDI sistem." Translation: "The manufacturer, the authorised representative, i.e. the importer, supplies the information needed for the registration of medical devices and legal persons, as well as the data submitted for the UDI database and the UDI system." Verbatim Član 8 stav 1 tačka 3: "osnovni identifikator medicinskog sredstva (UDI-DI);" and tačka 4: "naziv medicinskog sredstva, kataloški broj ili drugo nedvosmisleno upućivanje koje omogućava identifikaciju i sljedljivost medicinskog sredstva (po potrebi fotografija), kao i njegovu namjenu;". Translation: "the basic UDI-DI of the medical device;" and "the name of the medical device, catalogue number or other unambiguous reference enabling the identification and traceability of the medical device (photograph where necessary), as well as its intended purpose;".

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Safety corrective action must be notified without delay

vigilance.field-safety-corrective-action-notification
Fact-level verified
Statement

The manufacturer, or the authorised representative, must notify the Institute without delay of an initiated safety corrective measure and must give a safety notice to all the entities listed in the incident-reporting article. The manufacturer or authorised representative must also give the notified or designated body that carried out the conformity assessment information on all changes arising from the vigilance system where those changes affect the conformity of the device.

Report Timing

without delay (bez odlaganja)

Effective from 2024-10-01

Verbatim: "Proizvođač, odnosno ovlašćeni predstavnik dužan je da, bez odlaganja, obavijesti Agenciju o iniciranoj sigurnosno korektivnoj mjeri. Proizvođač odnosno ovlašćeni predstavnik dužni su da daju sigurnosno obavještenje svim subjektima iz člana 114 ovog zakona." Source language: Montenegrin.

Who must report an incident to the Institute, and what counts as an incident

vigilance.incident-reporting-to-the-institute
Fact-level verified
Statement

Healthcare institutions or vigilance coordinators, healthcare professionals, the manufacturer or its authorised representative, wholesalers, persons involved in the delivery or putting into service of a medical device, and persons responsible for calibration and maintenance of a device must inform the Institute without delay of a medical device incident: (1) any malfunction or alteration of the characteristics or performance of a device, and any irregularity in the labelling or instructions for use, which have led or may lead to the death of a patient or user or to a serious deterioration in their state of health; and (2) any technical or medical cause related to the device's performance that is the reason for the manufacturer or its authorised representative to withdraw from the market a device of the same type. Those entities must also inform the manufacturer or the authorised representative. The Institute notifies the health inspection and proposes appropriate measures.

Report To Authority

Institut za ljekove i medicinska sredstva Crne Gore (CInMED)

Report Timing

without delay (bez odlaganja)

Effective from 2024-10-01

Verbatim: "Zdravstvene ustanove, odnosno koordinatori za vigilancu, zdravstveni radnici, proizvođač, odnosno ovlašćeni predstavnik, veleprodaje, lica uključena u isporuku ili stavljanje u upotrebu medicinskog sredstva, kao i lica odgovorna za kalibraciju i održavanje medicinskog sredstva, dužni su da, bez odlaganja, obavijeste Agenciju o slučaju incidenta medicinskog sredstva ..." Source language: Montenegrin.

Related structured datasets

Classification systems · 2 records
Open Montenegrin IVD classes A, B, C and D →
Id

montenegro:ivd

Jurisdiction Id

montenegro

Domains
  • ivd
Name

Montenegrin IVD classes A, B, C and D

Description

In vitro diagnostic medical devices are a separate kind of medical device under čl. 16 of the Zakon o medicinskim sredstvima, and CInMED classifies them on the Regulation (EU) 2017/746 axis. The notice of 18.06.2025 states that 'other' IVDs classified under Directive 98/79/EC are classified as class A under Regulation (EU) 2017/746, and that the devices moving to a higher class move into 'A sterilna, B, C, D'; the register records classes A, B, C and D alongside the legacy values Lista A, Lista B, Ostala IVD and Samotestiranje. CInMED applies the requirements of Regulation (EU) 2017/746 to these devices without Montenegro being bound by it, and the legacy Directive 98/79/EC declarations of conformity are no longer accepted after 26.05.2022.

Classes
  • Id

    a

    Label

    Class A

    Normalized Risk Level

    low

  • Id

    b

    Label

    Class B

    Normalized Risk Level

    medium

  • Id

    c

    Label

    Class C

    Normalized Risk Level

    high

  • Id

    d

    Label

    Class D

    Normalized Risk Level

    highest

Regulator

CInMED

Official Domains
  • cinmed.me
  • sluzbenilist.me
Source Status

official-source-verified

Reference Sources
  • Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 16 i 18

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Reviewed On

    2026-09-16

    Supports

    Čl. 16 makes the in vitro diagnostic medical device a separate kind of medical device, and čl. 18 assigns the classification of 'other' in vitro diagnostic devices to the manufacturer rather than to a notified or appointed body.

  • Title

    CInMED register of medical devices — public search form, class field medicinska_registar_klasa

    Url

    https://cinmed.me/medicinska-sredstva/registar-medicinskih-sredstava/

    Reviewed On

    2026-09-16

    Supports

    The register publishes the IVD values A, B, C, D alongside the legacy Lista A, Lista B, Ostala IVD and Samotestiranje, which is where the four-class IVD axis is evidenced in the regulator's own data.

Source Title

Institut za ljekove i medicinska sredstva Crne Gore — obavještenje od 18.06.2025 o načinu priznavanja deklaracije o usaglašenosti i EC sertifikata u postupcima za in vitro dijagnostička medicinska sredstva (IVDD na IVDR (EU) 2017/746)

Source Url

https://cinmed.me/wp-content/uploads/2025/06/dokument-2_18.06.2025.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
Open Montenegrin classes I, Is, Im, Ir, IIa, IIb and III →
Id

montenegro:medical-device

Jurisdiction Id

montenegro

Domains
  • medical-device
Name

Montenegrin classes I, Is, Im, Ir, IIa, IIb and III

Description

The national class axis of the Zakon o medicinskim sredstvima, not a projection of the EU MDR. Čl. 16 recognises three kinds of medical device (general, in vitro diagnostic and active implantable); čl. 17(1) grades general and active implantable devices into classes I, IIa, IIb and III by risk and delegates the classification conditions to the Ministry; čl. 18 puts the classification in the hands of a notified or appointed body, except for Class I and 'other' in vitro diagnostic devices, which the manufacturer classifies itself, with disputes decided by the Ministry or the Agency. CInMED's register adds Is, Im and Ir, and records active implantable devices as a separate category (AIMD). A CE certificate or other foreign conformity document is recognised as an input under the Pravilnik o priznavanju inostranih isprava i CE znaka, but recognising it is not the same as being governed by the MDR: the device still has to be entered in the CInMED register before it may be placed on the Montenegrin market.

Classes
  • Id

    i

    Label

    Class I

    Normalized Risk Level

    low

  • Id

    is

    Label

    Class Is

    Normalized Risk Level

    low

  • Id

    im

    Label

    Class Im

    Normalized Risk Level

    low

  • Id

    ir

    Label

    Class Ir

    Normalized Risk Level

    low

  • Id

    iia

    Label

    Class IIa

    Normalized Risk Level

    medium

  • Id

    iib

    Label

    Class IIb

    Normalized Risk Level

    high

  • Id

    iii

    Label

    Class III

    Normalized Risk Level

    highest

Regulator

CInMED

Official Domains
  • cinmed.me
  • sluzbenilist.me
Source Status

official-source-verified

Reference Sources
  • Title

    CInMED register of medical devices — public search form, class field medicinska_registar_klasa

    Url

    https://cinmed.me/medicinska-sredstva/registar-medicinskih-sredstava/

    Reviewed On

    2026-09-16

    Supports

    CInMED's own register search publishes a class field (medicinska_registar_klasa) whose option values are C, I, IIb, IIa, Ostala IVD, Is, III, Lista A, Samotestiranje, AIMD, B, Im, A, Lista B, D and Ir. That vocabulary is the evidence for the Is, Im and Ir classes and for treating active implantable devices (AIMD) as a separate register category alongside the class axis.

  • Title

    Pravilnik o priznavanju inostranih isprava i CE znaka i o registraciji medicinskog sredstva, Službeni list Crne Gore br. 85/22 i 126/22

    Url

    https://cinmed.me/wp-content/uploads/2022/12/Pravilnik-o-priznavanju-inostranih-isprava-i-CE-znaka-i-o-registraciji-med_sred.pdf

    Reviewed On

    2026-09-16

    Supports

    The rulebook that governs how a foreign conformity document and the CE marking are recognised in the registration procedure conducted by the Institute, and what the registration application must contain.

  • Title

    Institut za ljekove i medicinska sredstva Crne Gore — obavještenje od 18.06.2025 o načinu priznavanja deklaracija o usaglašenosti i EC sertifikata (MDD/AIMD na MDR)

    Url

    https://cinmed.me/wp-content/uploads/2025/06/dokument-1_18.06.2025.pdf

    Reviewed On

    2026-09-16

    Supports

    Item 3 names the higher-risk classes as 'Is, Im, IIa, IIb, III i AIMD' and gives the transitional marketing deadlines of 31.12.2028 for devices that move up a class; the notice also states that an EC declaration issued under the MDD/AIMD is no longer accepted as a valid document where the device is not aligned with Regulation (EU) 2017/745.

Source Title

Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 16, 17 i 18

Source Url

https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

Verified On

2026-09-16

Source Supports
  • class-axis
  • classification-rules
Registration pathways, prior approvals and planning · 1 record
Open Montenegro registration →
Country

Montenegro

Jurisdiction Id

montenegro

Country Code

ME

Flag

🇲🇪

Regulator

Institut za ljekove i medicinska sredstva Crne Gore

Regulator Abbrev

CInMED

Region

europe

Tier

3

Risk Classification

4-class (I, IIa, IIb, III) under the Zakon o medicinskim sredstvima; CInMED's register adds Is, Im and Ir and records active implantable devices (AIMD) as a separate category, and in vitro diagnostic devices on the separate A, B, C, D axis

Classes
  • Id

    registration-class-i

    Class Name

    Class I — registration of the medical device in the CInMED register

    Risk Level

    low

    Pathway

    Application for entry in the register of medical devices, filed with CInMED before the device is placed on the market by the manufacturer established in Montenegro or by its authorised representative (čl. 38(1))

    Official Timeline
    Min

    90

    Max

    90

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 37, 38 i 40

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    3

    Max

    6

    Notes
    • Čl. 40(1) gives CInMED 90 days from receipt of complete documentation to decide on the registration application; the period does not vary by risk class, which is why the row is bound to the route rather than to a class.
    • Čl. 40(3) allows a 30-day period to remedy an incomplete application, and čl. 40(4) suspends the 90-day clock for as long as the application is incomplete.
    • Čl. 41(2) gives a Class I device that is neither sterile nor has a measuring function, and an 'other' in vitro diagnostic device, a five-year registration on the manufacturer's own declaration; for every other device čl. 41(1) ties the validity to the conformity document, up to 60 days beyond its expiry.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    registration-class-iia-iib-iii

    Class Name

    Class IIa, IIb and III — registration of the medical device in the CInMED register

    Risk Level

    high

    Pathway

    Application for entry in the register of medical devices after conformity has been determined by a notified or appointed body (čl. 18), filed by the manufacturer established in Montenegro or its authorised representative (čl. 38(1))

    Official Timeline
    Min

    90

    Max

    90

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 37, 38 i 40

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    4

    Max

    9

    Notes
    • The same čl. 40(1) clock of 90 days from complete documentation applies to Class IIa, IIb and III; the statute sets no separate period per class.
    • The clock is administrative only: it starts when the documentation is complete, and for these classes the conformity assessment itself is performed by a notified or appointed body under čl. 18, whose duration the Law does not fix.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    unregistered-import-authorisation

    Class Name

    Authorisation to import a medical device that is not registered (čl. 66)

    Pathway

    Request to CInMED for authorisation to import an unregistered medical device

    Official Timeline
    Min

    30

    Max

    30

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 66 i 67

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    1

    Max

    2

    Notes
    • Čl. 67(2) gives CInMED 30 days to decide the request; the period is not expressed per risk class, so the row is bound to the import-authorisation route.
    • This is a permit clock, not a registration clock: it lets an unregistered device be imported without being entered in the register.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    clinical-investigation-approval

    Class Name

    Approval to start a clinical investigation of a medical device

    Pathway

    Request to CInMED for approval to begin a clinical investigation, including a positive opinion of the ethics committee

    Official Timeline
    Min

    40

    Max

    40

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 94 i 101

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    4

    Notes
    • Čl. 94(1) gives CInMED 40 days from a complete request, including the positive opinion of the ethics committee, to decide on the start of a clinical investigation.
    • Čl. 94(2) requires a notice of incompleteness within 10 days and gives the applicant 20 days to supplement; čl. 94(3) suspends the 40-day clock while the request is incomplete.
    • Čl. 101(3) requires CInMED to issue a certificate of receipt within 15 days for a post-market non-interventional study.
    Clinical Trial Required

    Yes

    Local Testing Required

    No

    Gmp Required

    No

  • Id

    registration-amendment-and-renewal

    Class Name

    Amendment and renewal of a registration decision

    Pathway

    Request to CInMED to amend or to renew a decision entering a medical device in the register

    Official Timeline
    Min

    60

    Max

    60

    Unit

    days

    Verification Status

    official-verified

    Official Source
    Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 41, 42 i 44

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

    Realistic Timeline
    Min

    2

    Max

    3

    Notes
    • Čl. 42(3) gives CInMED 60 days to decide an application to amend a registration decision, and čl. 44(2) gives it 60 days to decide a renewal; neither period varies by risk class.
    • Čl. 41(3) adds a 90-day tail during which a device may still be placed on the market after the registration lapses, and čl. 41(4) prohibits import during that tail.
    Clinical Trial Required

    No

    Local Testing Required

    No

    Gmp Required

    No

Prior Approvals
  • Authority

    EU CE marking under Regulation (EU) 2017/745 (MDR)

    Accepted

    Yes

    Benefit

    A declaration of conformity or EC certificate issued by an EU manufacturer or an EU-notified body is recognised as the conformity input in the CInMED registration procedure under the Pravilnik o priznavanju inostranih isprava i CE znaka, and it lowers the fee line for devices that would otherwise be registered without an EU conformity document. It does not remove the national registration, and CInMED no longer accepts declarations issued under the MDD/AIMD that are not aligned with Regulation (EU) 2017/745.

  • Authority

    US FDA 510(k) clearance or PMA approval

    Accepted

    No

    Benefit

    No substitute for the conformity documents recognised by CInMED; useful only as supporting technical documentation in the file.

Key Requirements
  • File the registration application with CInMED before placing the device on the market, as a manufacturer established in Montenegro or through an authorised representative established there (čl. 38(1)).
  • Designate the responsible person for documentation and the responsible person for vigilance (čl. 38(1)).
  • Submit the instructions for use in Montenegrin (Uputstvo, item 9) and proof of the manufacturer's product-liability insurance (Uputstvo, item 6).
  • Submit an ISO 13485 certificate or a free-sale certificate for the device (Uputstvo, item 11).
  • Pay the prescribed fee: under the Uputstvo, payment of the prescribed fee is a condition for processing the application.
  • Where the manufacturer has no seat, residence or domicile in Montenegro, register the foreign manufacturer before the device registration (Uputstvo, item 3).
  • For a device without a conformity document issued by an EU manufacturer or an EU-notified body, expect the higher fee line and the additional conformity assessment conducted by CInMED.
  • File a prior application with CInMED for a clinical investigation and obtain a positive opinion of the ethics committee (čl. 94(1)).
Local Rep Required

Yes

Local Rep Name

Authorised representative of the manufacturer established in Montenegro (zastupnik proizvođača), plus the responsible persons for documentation and for vigilance

Mdsap Accepted

No

Mdsap Benefit

An ISO 13485 certificate is accepted as quality-system evidence in the registration file (Uputstvo, item 11); MDSAP is not separately recognised.

Registration Validity

Tied to the validity of the conformity document, up to 60 days beyond its expiry (čl. 41(1)); five years for Class I devices that are neither sterile nor measuring, and for 'other' in vitro diagnostic devices, registered on the manufacturer's declaration (čl. 41(2)); a 90-day market tail applies after the registration lapses, during which import is prohibited (čl. 41(3) and (4))

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 od 22.04.2019 i 084/24, čl. 37, 38 i 40

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

  • Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 66 i 67

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

  • Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 94 i 101

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

  • Title

    Zakon o medicinskim sredstvima (prečišćeni tekst), Službeni list Crne Gore br. 024/19 i 084/24, čl. 41, 42 i 44

    Url

    https://cinmed.me/wp-content/uploads/2024/10/Zakon-o-medicinskim-sredstvima.pdf

    Accessed Date

    2026-09-16

  • Title

    CInMED — Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva, updated 18 March 2026

    Url

    https://cinmed.me/wp-content/uploads/2026/03/Uputstvo-za-podnosioce-zahtjeva-za-registraciju-medicinskog-sredstva_azurirano-18.marta_.2026.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Process
Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps
  • Step

    1

    Title

    Pre-Submission Preparation

    Description

    Gather technical documentation, quality management system (QMS) records, and clinical data required by CInMED. Appoint a Authorised representative of the manufacturer established in Montenegro (zastupnik proizvođača), plus the responsible persons for documentation and for vigilance.

    Duration

    1-3 months

    Icon

    📋

  • Step

    2

    Title

    Application Submission

    Description

    Submit complete registration dossier to CInMED including device description, risk analysis, and testing reports.

    Duration

    1-2 weeks

    Icon

    📤

  • Step

    3

    Title

    Administrative Review

    Description

    CInMED reviews application for completeness. May request additional documents or clarifications.

    Duration

    2-4 weeks

    Icon

    🔍

  • Step

    4

    Title

    Technical Evaluation

    Description

    In-depth technical assessment of device safety and performance. CInMED may issue questions.

    Duration

    90 days

    Icon

    ⚙️

  • Step

    5

    Title

    Registration Approval

    Description

    Upon successful review, CInMED issues Montenegro market authorization certificate.

    Duration

    1-2 weeks

    Icon

    ✅

Government fee schedules · 1 record
Open Montenegro fees →
Jurisdiction Id

montenegro

Country

Montenegro

Country Code

ME

Authority

CInMED

Low Risk Local
Min

60

Max

100

Currency

EUR

Per Product

Yes

High Risk Local
Min

200

Max

400

Currency

EUR

Per Product

Yes

Details
  • Id

    registration-class-i-up-to-25

    Item

    Registration of Class I medical devices — up to 25 products in the application

    Currency

    EUR

    Amount Local

    100

    Amount Local Formatted

    EUR 100

    Frequency

    Per application, tiered by the number of products

    Notes

    Odluka čl. 2, item 2.1, Class I, up to 25 products.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    registration-class-i-over-100

    Item

    Registration of Class I medical devices — over 100 products in the application

    Currency

    EUR

    Amount Local

    60

    Amount Local Formatted

    EUR 60

    Frequency

    Per application, tiered by the number of products

    Notes

    Odluka čl. 2, item 2.1, Class I, over 100 products; the 26-100 tier is EUR 80.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    registration-class-iia-up-to-25

    Item

    Registration of Class IIa medical devices — up to 25 products in the application

    Currency

    EUR

    Amount Local

    200

    Amount Local Formatted

    EUR 200

    Frequency

    Per application, tiered by the number of products

    Notes

    Odluka čl. 2, item 2.1, Class IIa, up to 25 products; the 26-100 tier is EUR 180 and the over-100 tier EUR 150.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    registration-class-iib-up-to-25

    Item

    Registration of Class IIb medical devices — up to 25 products in the application

    Currency

    EUR

    Amount Local

    300

    Amount Local Formatted

    EUR 300

    Frequency

    Per application, tiered by the number of products

    Notes

    Odluka čl. 2, item 2.1, Class IIb, up to 25 products; the 26-100 tier is EUR 250 and the over-100 tier EUR 200.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    registration-class-iii-up-to-15

    Item

    Registration of Class III medical devices — up to 15 products in the application

    Currency

    EUR

    Amount Local

    400

    Amount Local Formatted

    EUR 400

    Frequency

    Per application, tiered by the number of products

    Notes

    Odluka čl. 2, item 2.1, Class III, up to 15 products; over 15 products is EUR 350.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    registration-ivd-up-to-25

    Item

    Registration of in vitro diagnostic medical devices — up to 25 products in the application

    Currency

    EUR

    Amount Local

    100

    Amount Local Formatted

    EUR 100

    Frequency

    Per application, tiered by the number of products

    Notes

    Odluka čl. 2, item 2.1, IN VITRO, up to 25 products; the 26-100 tier is EUR 80 and the over-100 tier EUR 60.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    registration-active-implantable-up-to-10

    Item

    Registration of active implantable devices and of apparatus belonging to classes I, IIa, IIb and III, and in vitro apparatus — up to 10 products

    Currency

    EUR

    Amount Local

    450

    Amount Local Formatted

    EUR 450

    Frequency

    Per application, tiered by the number of products

    Notes

    Odluka čl. 2, item 2.1, the line covering AIMD and apparatus of classes I, IIa, IIb and III and in vitro apparatus, up to 10 products; 11-25 products is EUR 400 and over 25 is EUR 350.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    unregistered-import-authorisation-up-to-5

    Item

    Authorisation to import unregistered medical devices, under čl. 66 of the Law — up to 5 devices

    Currency

    EUR

    Amount Local

    60

    Amount Local Formatted

    EUR 60

    Frequency

    Per authorisation, tiered by the number of devices

    Notes

    Odluka čl. 2, item 2.3; 6-10 devices is EUR 100, 11-15 is EUR 150, 16-20 is EUR 200 and over 20 is EUR 250. Čl. 67(2) of the Law gives CInMED 30 days to decide.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    vigilance-class-iii

    Item

    Annual vigilance-system maintenance per decision — Class III medical devices

    Currency

    EUR

    Amount Local

    40

    Amount Local Formatted

    EUR 40

    Frequency

    Per decision, annually

    Notes

    Odluka čl. 2, the vigilance line: Class I EUR 10, in vitro diagnostic devices EUR 10, Class IIa EUR 20, Class IIb EUR 30, Class III EUR 40, active implantable devices EUR 45.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    classification-decision-medical-device

    Item

    Decision on the classification of a medical device

    Currency

    EUR

    Amount Local

    300

    Amount Local Formatted

    EUR 300

    Frequency

    Per request

    Notes

    Odluka čl. 2, the decision line, classification of medical devices. The same line charges EUR 150 for deciding the classification of a drug/medical-device combination and EUR 150 for a medical device combined with an article of general use.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

  • Id

    registration-without-eu-conformity-document-class-iii

    Item

    Registration of a Class III medical device without a conformity document issued by an EU manufacturer or an EU-notified conformity-assessment body

    Currency

    EUR

    Amount Local

    600

    Amount Local Formatted

    EUR 600

    Frequency

    Per application

    Notes

    Odluka čl. 2, the line for devices without a conformity document from an EU manufacturer or an EU-notified body: Class I EUR 200, Class IIa EUR 500, Class IIb EUR 500, Class III EUR 600, active implantable devices and apparatus EUR 600, in vitro diagnostic devices EUR 200.

    Amount Status

    exact-current

    Verification Status

    official-verified

    Source Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Source Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Verified On

    2026-09-16

Notes
  • Čl. 2 of the Odluka prices registration by risk class and by the number of products in one application: Class I and in vitro diagnostic devices EUR 100 / 80 / 60 for up to 25, 26 to 100 and over 100 products; Class IIa EUR 200 / 180 / 150; Class IIb EUR 300 / 250 / 200; Class III EUR 400 up to 15 products and EUR 350 over 15; active implantable devices and apparatus EUR 450 / 400 / 350.
  • Extension of a registration (produženje registracije) is not published as a fixed amount: čl. 2 sets it at 50% of the fee determined for the first entry of that medical device in the register, so it is deliberately not published here as an exact figure.
  • All amounts in the Odluka are expressed exclusive of VAT (Obrazloženje: sve cijene u ovoj odluci izražene bez PDV-a), and čl. 4 gives the applicant 30 days from receipt of the invoice to pay.
  • Čl. 5 refunds a withdrawal notified in writing within 7 days of filing, less 30% of the amount paid; a later withdrawal forfeits the whole fee.
  • The Odluka was adopted by the Upravni odbor of the Institut za ljekove i medicinska sredstva on 27.12.2022 and published in Sl. list CG 035/23 of 27.03.2023; čl. 7 makes it enter into force on the eighth day after publication, following the Government's consent.
  • The annual-fee table in čl. 3 is published only as a scanned image, so no figure from it is published; the Obrazloženje states the new annual maintenance fee for manufacturing and wholesale/retail authorisations ranges from 80 to 100 EUR.
Last Updated

2026-09-16

Verification Status

official-verified

Official Sources
  • Title

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Službeni list Crne Gore br. 035/23 od 27.03.2023, čl. 2 i 4-7

    Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

    Accessed Date

    2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record
Open Montenegro certifications →
Slug

montenegro

Market

Montenegro

Confidence

low

Schemes
  • Id

    montenegro-electrical-equipment-safety

    Name

    Montenegrin electrical-equipment safety requirements

    Category

    Medical Electrical Safety

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    The horizontal electrical-safety regime is the Zakon o tehničkim zahtjevima za proizvode i ocjenjivanje usaglašenosti (Sl. list CG 53/2011, in force 19.11.2011, still current on the gazette register), whose implementing rulebook is now the Pravilnik o električnoj opremi namijenjenoj za upotrebu u okviru određenih naponskih granica (Sl. list CG 87/2026, published 24.06.2026, in force 02.07.2026). A medical device is not certified separately against that rulebook in Montenegro: the device's electrical safety is part of the conformity documented to CInMED, and the register entry rests on the recognised conformity documents. The exact rulebook text was not retrieved — only its official gazette record — so the binding is a candidate.

    Source Urls
    • https://www.sluzbenilist.me/propisi/337364
    • https://www.sluzbenilist.me/propisi/395391
    Source Binding

    candidate

  • Id

    montenegro-emc

    Name

    Montenegrin electromagnetic-compatibility requirements

    Category

    emc

    Status

    Included In Medical Registration

    Object

    Finished Device

    Note

    Electromagnetic compatibility for equipment placed on the Montenegrin market is governed by the Pravilnik o elektromagnetnoj kompatibilnosti za opremu koja se isporučuje na tržište (Sl. list CG 88/2017, published 26.12.2017, still current). As with electrical safety, a medical device is documented to CInMED through its conformity documents rather than certified separately against the EMC rulebook. The rulebook text was not retrieved — only its official gazette record — so the binding is a candidate.

    Source Urls
    • https://www.sluzbenilist.me/propisi/338814
    Source Binding

    candidate

  • Id

    ekip-radio-equipment

    Name

    EKIP radio-equipment market access

    Category

    Radio Spectrum

    Status

    Mandatory If Feature

    Object

    Radio Equipment

    Note

    Radio equipment placed on the Montenegrin market must meet the Pravilnik o radio opremi (Sl. list CG 127/2026, published 28.08.2026, in force 05.09.2026), the current instrument adopted under the Zakon o tehničkim zahtjevima za proizvode. It applies to a medical device only if the device contains a radio transmitter or receiver, in which case the radio equipment must be able to use the spectrum allocated to terrestrial and space radio communication without causing harmful interference; the Agency for Electronic Communications and Postal Services (EKIP) is the market-surveillance authority. A medical device that is not radio equipment carries no separate EKIP obligation.

    Source Urls
    • https://www.ekip.me/media/documents/general/1788418837_Pravilnik%20o%20radio%20opremi%20-%20Sluzbeni%20list%20CG%20127-26.pdf
    • https://www.sluzbenilist.me/propisi/397589
    Source Binding

    candidate

  • Id

    montenegro-legal-metrology

    Name

    Montenegrin legal metrology — type approval and verification of measuring instruments

    Category

    Legal Metrology

    Status

    Mandatory If Feature

    Object

    Measuring Instrument

    Note

    The Zavod za metrologiju Crne Gore (the Montenegrin Metrology Institute) publishes the national metrology legislation and operates type approval and verification of measuring instruments, including its approved-types register and its verification laboratories, one of which is the laboratory for ionizing radiation. Where a medical device has a measuring function it falls under the legal-metrology regime in addition to the medical-device registration. The instrument text was not read in full — the legislation index and the consolidated Zakon o metrologiji file were retrieved — so the binding is a candidate.

    Source Urls
    • https://metrologija.me/propisi
    • https://metrologija.me/wp-content/uploads/zakonodavstvo/propisi/1zakonometrologiji.pdf
    Source Binding

    candidate

  • Id

    epa-ionizing-radiation

    Name

    EPA Montenegro ionizing-radiation protection

    Category

    Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Ionizing Radiation Equipment

    Note

    The Agencija za zaštitu životne sredine (EPA Montenegro) carries the Department for Radiological and Nuclear Safety and Protection against Ionizing and Non-Ionizing Radiation, which is the body that authorises and supervises radiation sources and issues radiation-protection approvals. A medical device that contains a radiation source therefore engages the department in addition to CInMED. The department page is the authority's own statement of its remit; the underlying radiation-protection statute was not retrieved, so the binding is a candidate.

    Source Urls
    • https://epa.org.me/odjeljenje-za-radiolosku-i-nuklearnu-sigurnost-i-bezbjednost-i-zastitu-od-jonizujuceg-i-nejonizujuceg-zracenja/
    Source Binding

    reviewed

  • Id

    montenegro-non-ionizing-radiation

    Name

    Montenegrin non-ionizing radiation protection

    Category

    Non Ionizing Radiation

    Status

    Mandatory For Use Site

    Object

    Non Ionizing Radiation Source

    Note

    The Zakon o zaštiti od nejonizujućih zračenja (Sl. list CG 35/2013, published 23.07.2013, in force 31.07.2013, application from 01.07.2015) is the statute on protection against non-ionizing radiation, and the same EPA department administers the ionizing and non-ionizing remit. A device that is a source of non-ionizing radiation — for example an infrared or laser therapeutic device — is caught by it in addition to the medical-device registration. The statute text was not retrieved, so the binding is a candidate.

    Source Urls
    • https://www.sluzbenilist.me/propisi/335993
    Source Binding

    candidate

  • Id

    montenegro-waste-management

    Name

    Montenegrin waste-management duties for electrical and electronic equipment

    Category

    Environmental And Batteries

    Status

    Mandatory If Feature

    Object

    Electrical And Electronic Equipment

    Note

    The Zakon o upravljanju otpadom (Sl. list CG 34/2024, published 12.04.2024, in force 20.04.2024) is the waste-management framework, administered by EPA Montenegro, and it is the statute under which producer responsibility for waste electrical and electronic equipment and for waste batteries is imposed. It binds a producer or importer of a medical device that is electrical or electronic equipment, not the device's market authorisation. The statute text was retrieved only as a PDF from the Agency's own site and was not read in full, so the binding is a candidate.

    Source Urls
    • https://www.sluzbenilist.me/propisi/368332
    • https://epa.org.me/wp-content/uploads/2024/11/Zakon-o-upravljanju-otpadom.pdf
    Source Binding

    candidate

  • Id

    cinmed-registration-and-import

    Name

    CInMED registration and unregistered-import authorisation

    Category

    Import Conformity

    Status

    Mandatory At Import

    Object

    Finished Device

    Note

    Čl. 37 of the Zakon o medicinskim sredstvima requires CInMED to keep the register of medical devices, and čl. 38(1) requires an application to be filed before the device is placed on the market by a manufacturer established in Montenegro or its authorised representative, together with the responsible persons for documentation and for vigilance. Čl. 37(2) is explicit that registration is not a condition for placing the device on the market, but čl. 41(3) and (4) prohibit import of a device whose registration has lapsed and whose 90-day market tail has run out, and čl. 66 makes the import of an unregistered device subject to an authorisation decided by CInMED within 30 days (čl. 67(2)). The registration page and the regulatory index were read.

    Source Urls
    • https://cinmed.me/medicinska-sredstva/registracija/
    • https://cinmed.me/regulativa/regulativa-medicinskih-sredstava/
    Source Binding

    reviewed

Official Sources
  • Authority

    Skupština Crne Gore / Službeni list Crne Gore

    Topic

    Zakon o tehničkim zahtjevima za proizvode i ocjenjivanje usaglašenosti, Sl. list CG 53/2011

    Url

    https://www.sluzbenilist.me/propisi/337364

  • Authority

    Službeni list Crne Gore

    Topic

    Pravilnik o električnoj opremi namijenjenoj za upotrebu u okviru određenih naponskih granica, Sl. list CG 87/2026

    Url

    https://www.sluzbenilist.me/propisi/395391

  • Authority

    Službeni list Crne Gore

    Topic

    Pravilnik o elektromagnetnoj kompatibilnosti za opremu koja se isporučuje na tržište, Sl. list CG 88/2017

    Url

    https://www.sluzbenilist.me/propisi/338814

  • Authority

    EKIP (Agencija za elektronske komunikacije i poštansku djelatnost)

    Topic

    Pravilnik o radio opremi, Sl. list CG 127/2026

    Url

    https://www.ekip.me/media/documents/general/1788418837_Pravilnik%20o%20radio%20opremi%20-%20Sluzbeni%20list%20CG%20127-26.pdf

  • Authority

    Službeni list Crne Gore

    Topic

    gazette record for the Pravilnik o radio opremi, Sl. list CG 127/2026

    Url

    https://www.sluzbenilist.me/propisi/397589

  • Authority

    Zavod za metrologiju Crne Gore

    Topic

    national metrology legislation index

    Url

    https://metrologija.me/propisi

  • Authority

    Zavod za metrologiju Crne Gore

    Topic

    Zakon o metrologiji, consolidated text

    Url

    https://metrologija.me/wp-content/uploads/zakonodavstvo/propisi/1zakonometrologiji.pdf

  • Authority

    Agencija za zaštitu životne sredine (EPA Montenegro)

    Topic

    Department for Radiological and Nuclear Safety and Protection against Ionizing and Non-Ionizing Radiation

    Url

    https://epa.org.me/odjeljenje-za-radiolosku-i-nuklearnu-sigurnost-i-bezbjednost-i-zastitu-od-jonizujuceg-i-nejonizujuceg-zracenja/

  • Authority

    Službeni list Crne Gore

    Topic

    Zakon o zaštiti od nejonizujućih zračenja, Sl. list CG 35/2013

    Url

    https://www.sluzbenilist.me/propisi/335993

  • Authority

    Službeni list Crne Gore

    Topic

    Zakon o upravljanju otpadom, Sl. list CG 34/2024

    Url

    https://www.sluzbenilist.me/propisi/368332

  • Authority

    Agencija za zaštitu životne sredine (EPA Montenegro)

    Topic

    Zakon o upravljanju otpadom, text published by the Agency

    Url

    https://epa.org.me/wp-content/uploads/2024/11/Zakon-o-upravljanju-otpadom.pdf

  • Authority

    CInMED

    Topic

    registration of medical devices

    Url

    https://cinmed.me/medicinska-sredstva/registracija/

  • Authority

    CInMED

    Topic

    regulatory framework for medical devices

    Url

    https://cinmed.me/regulativa/regulativa-medicinskih-sredstava/

  • Authority

    CInMED

    Topic

    Pravilnik o priznavanju inostranih isprava i CE znaka i o registraciji medicinskog sredstva, Sl. list CG 85/22 i 126/22

    Url

    https://cinmed.me/wp-content/uploads/2022/12/Pravilnik-o-priznavanju-inostranih-isprava-i-CE-znaka-i-o-registraciji-med_sred.pdf

  • Authority

    CInMED

    Topic

    Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva, updated 18 March 2026

    Url

    https://cinmed.me/wp-content/uploads/2026/03/Uputstvo-za-podnosioce-zahtjeva-za-registraciju-medicinskog-sredstva_azurirano-18.marta_.2026.pdf

  • Authority

    CInMED

    Topic

    register of medical devices, public search

    Url

    https://cinmed.me/medicinska-sredstva/registar-medicinskih-sredstava/

  • Authority

    CInMED

    Topic

    Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Sl. list CG 035/23

    Url

    https://cinmed.me/wp-content/uploads/2023/04/Odluka-o-visini-i-nacinu-placanja-naknada-za-vrsenje-strucnih-poslova-u-vezi-sa-medicinskim-sredstvima-2.pdf

Keep researching this market

More Montenegro medical device resources

View the Montenegro resource hub →
Continue with this market
DJ Fang
Need to apply Montenegro's requirements to a product?
Confirm the current CInMED pathway, evidence, and local-role details for the actual device before filing.
Pricing