Montenegro medical device registration timeline

Source-linked clocks

Institut za ljekove i medicinska sredstva Crne Gore (CInMED) review clocks and end-to-end planning ranges, using the 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 classification system.

5 pathways5 of 5 clocks verifiedvalidity 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))MDSAP not acceptedreviewed 2026-09-16cinmed.me

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I — registration of the medical device in the CInMED register(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))) 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.	90 days	3-6 months	—	Verified
Class IIa, IIb and III — registration of the medical device in the CInMED register(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))) 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.	90 days	4-9 months	—	Verified
Authorisation to import a medical device that is not registered (čl. 66)(Request to CInMED for authorisation to import an unregistered medical device) 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.	30 days	1-2 months	—	Verified
Approval to start a clinical investigation of a medical device(Request to CInMED for approval to begin a clinical investigation, including a positive opinion of the ethics committee) 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.	40 days	2-4 months	—	Verified
Amendment and renewal of a registration decision(Request to CInMED to amend or to renew a decision entering a medical device in the register) 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.	60 days	2-3 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Montenegro Medical Device Registration Process

Step-by-step CInMED registration process. Total estimated timeline: 3-6 months.

Step 1: Pre-Submission Preparation

1-3 months

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.

Step 2: Application Submission

1-2 weeks

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

Step 3: Administrative Review

2-4 weeks

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

Step 4: Technical Evaluation

90 days

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

Step 5: Registration Approval

1-2 weeks

Upon successful review, CInMED issues Montenegro market authorization certificate.

Summary: The Montenegro medical device registration process through Institut za ljekove i medicinska sredstva Crne Gore (CInMED) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

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

US FDA 510(k) clearance or PMA approvalNo 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)).

Primary regulator sources

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

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against CInMED publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:montenegro:registration-class-i