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CInMED · structured requirements

🇲🇪 Montenegro IVD regulatory data

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

18 facts12 dimensions6 official sourceslatest verification 2026-09-17

Changes after registration

Explore questions and sources →

Common questions about changing a registered IVD in Montenegro. Each question separates published rules from details still awaiting verification.

Approval validity & renewal

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

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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.

Change control

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

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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?

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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)."

Dossier requirements

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

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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."

Official forms & portals

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

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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?

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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."

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."

Registration pathways

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

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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.

Reliance & recognition

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

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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 (5 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.

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.

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

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

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A device meets the essential requirements if it meets Montenegrin standards adopting harmonised European or international standards published in the Official Gazette

standards.harmonised-standards-conformity
Fact-level verified

A device is deemed to meet essential requirements when it conforms to Montenegrin standards adopting the corresponding harmonised European or international standards, whose list is published in the Official Gazette of Montenegro. Article 22 includes the relevant national pharmacopoeia monographs and current European Pharmacopoeia monographs, particularly those concerning surgical sutures.

Montenegrin original.

Submission communications & appeal

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

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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, 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?

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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 · 1 record
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
Registration pathways, prior approvals and planning · 1 record

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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

These country-level records can cover multiple product types. Check each item's scope and conditions before applying a fee, pathway or licence to an IVD.

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

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