Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksMontenegro medical device certification and licence checker
Check Montenegro requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
8 maintained routes17 official source links
Preliminary applicability · country-specific scope
What you receive
Not just a yes or no
A route-by-route answer. Separate product certificates, dossier evidence, import documents, and facility licences stay separate.
Trigger reasoning. See which product facts matter and which missing facts prevent a reliable conclusion.
Official starting points. Open the regulator or government sources behind the maintained country matrix.
How to read the answer
Classification is only the first layer
A device may have one medical risk class and still trigger separate radio, electrical, measurement, radiation, environmental, import, or installation requirements. The checker keeps each regulatory object separate.
Dossier or import evidence
Testing can belong inside the medical dossier, while some documents apply to each shipment.
Site or operator licence
Radiation, installation, use, or measurement controls may apply to a facility or operator.
Country-specific scope
Medical device certification routes in Montenegro
Electrical safety
Montenegrin electrical-equipment safety requirements
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
EMC
Montenegrin electromagnetic-compatibility requirements
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Wireless / radio
EKIP radio-equipment market access
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Metrology
Montenegrin legal metrology — type approval and verification of measuring instruments
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Radiation
EPA Montenegro ionizing-radiation protection
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
Laser / UV / ultrasound
Montenegrin non-ionizing radiation protection
Applies to the facility, operator, or installation rather than only the product.
Source association awaiting review
Environmental / battery
Montenegrin waste-management duties for electrical and electronic equipment
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Import CoC / PVoC
CInMED registration and unregistered-import authorisation
Handled as an import or shipment-level obligation.
Source association reviewed
Official starting points
Use these authority pages to confirm current scope, technical rules, application routes, and transition dates. A linked source does not turn a preliminary result into an authority decision.
Skupština Crne Gore / Službeni list Crne Gore
Zakon o tehničkim zahtjevima za proizvode i ocjenjivanje usaglašenosti, Sl. list CG 53/2011
Službeni list Crne Gore
Pravilnik o električnoj opremi namijenjenoj za upotrebu u okviru određenih naponskih granica, Sl. list CG 87/2026
Službeni list Crne Gore
Pravilnik o elektromagnetnoj kompatibilnosti za opremu koja se isporučuje na tržište, Sl. list CG 88/2017
EKIP (Agencija za elektronske komunikacije i poštansku djelatnost)
Pravilnik o radio opremi, Sl. list CG 127/2026
Službeni list Crne Gore
gazette record for the Pravilnik o radio opremi, Sl. list CG 127/2026
Zavod za metrologiju Crne Gore
national metrology legislation index
Zavod za metrologiju Crne Gore
Zakon o metrologiji, consolidated text
Agencija za zaštitu životne sredine (EPA Montenegro)
Department for Radiological and Nuclear Safety and Protection against Ionizing and Non-Ionizing Radiation
Službeni list Crne Gore
Zakon o zaštiti od nejonizujućih zračenja, Sl. list CG 35/2013
Službeni list Crne Gore
Zakon o upravljanju otpadom, Sl. list CG 34/2024
Agencija za zaštitu životne sredine (EPA Montenegro)
Zakon o upravljanju otpadom, text published by the Agency
CInMED
registration of medical devices
CInMED
regulatory framework for medical devices
CInMED
Pravilnik o priznavanju inostranih isprava i CE znaka i o registraciji medicinskog sredstva, Sl. list CG 85/22 i 126/22
CInMED
Uputstvo za podnosioce zahtjeva za registraciju medicinskog sredstva, updated 18 March 2026
CInMED
register of medical devices, public search
CInMED
Odluka o visini i načinu plaćanja naknada za vršenje stručnih poslova u vezi sa medicinskim sredstvima, Sl. list CG 035/23
About this checker
A preliminary tool, not a regulatory determination
Describe the complete product — radio, power, measurement, radiation, battery, materials, accessories, intended use, import route, and existing approvals. The free checker maps those facts to the maintained Montenegro scheme matrix and links each route to its maintained source associations, with reviewed, candidate and unresolved states shown separately.
Use the result to identify questions and official sources. Final scope can depend on exact models, modules, bands, components, claims, HS codes, import structure, installation site, and current authority interpretation.
- Is this the same as medical device classification in Montenegro?
- No. Risk classification determines the main medical-device pathway. This checker runs after classification and looks for additional product certificates, dossier evidence, import documents, and facility or operator licences.
- Does “no separate certificate” mean no testing is required?
- No. Safety, EMC, performance, or other evidence can still be required inside the medical-device dossier even when there is no separate national product certificate.
- Is the result an official regulatory determination?
- No. It is a preliminary applicability assessment. Review the linked official source and confirm the final route with the relevant authority, certification body, importer, or regulatory professional.
DJ Fang
MedTech Regulatory Expert
Need help confirming a classification or planning your registration?
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