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Does my medical device need CInMED registration and unregistered-import authorisation in Montenegro?

Describe your device to check whether CInMED registration and unregistered-import authorisation may apply, why, what facts are missing, and which official source to review.

1 maintained routes2 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.

Maintained country rule

What this CInMED registration and unregistered-import authorisation check is screening

Separates reusable product approval from consignment, customs, PVoC, CoC, and HS-code documents. Handled as an import or shipment-level obligation.

Source association reviewed. The source association has been reviewed. This does not verify every rule, date or product-specific conclusion; read the cited provisions and their limits.

Requirement family: Import conformity and shipment certificates
Regulatory object: finished device
Maintained rule status: mandatory at import
Useful product facts: HS code for every shipped object, shipment purpose, importer, origin, product certificate, and consignment details.

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.

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.

Product approval

A certificate or approval attached to the finished product, component, or radio host.

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

Other Montenegro routes to check

Check every Montenegro route →

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

Reviewed source associations

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.

CInMED

registration of medical devices

CInMED

regulatory framework for medical devices

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.