Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksDoes my medical device need Civil Protection Directorate approval for activities with ionizing-radiation sources in Croatia?
Describe your device to check whether Civil Protection Directorate approval for activities with ionizing-radiation sources may apply, why, what facts are missing, and which official source to review.
1 maintained routes1 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 Civil Protection Directorate approval for activities with ionizing-radiation sources check is screening
Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies to the facility, operator, or installation rather than only the product.
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
- Ionizing radiation and radioactive sources
- Regulatory object
- ionizing radiation sources and electrical radiation devices
- Maintained rule status
- mandatory for use site
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
An odobrenje za obavljanje djelatnosti must be obtained for the activities with ionizing-radiation sources listed in Article 14 of the Pravilnik o obavješćivanju, registriranju i odobrenjima te prometu izvorima ionizirajućeg zračenja (NN 54/18, 6/22). The Directorate's page lists the covered activities expressly including 'ELEKTRIČNI UREĐAJI KOJI PROIZVODE IONIZIRAJUĆE ZRAČENJE (rendgenski uređaji, akceleratori i slično)', so an X-ray or accelerator-based medical device is in scope even though it contains no radioactive source. The request goes to the Sektor za radiološku i nuklearnu sigurnost with the data required by Article 15(2) and the documents required by Articles 16, 17 and/or 18, the set depending on the activity; for radioactive sources Articles 19(2) and 20-23 apply. The page states that the approval is subject to administrative fees in force from 1 January 2023 but does not publish the amounts.
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
Other Croatia routes to check
Electrical safety
Low Voltage Directive exclusion for medical electrical equipment — electrical safety carried inside MDR conformity assessment
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
EMC
EMC Directive disapplied where MDR fixes the same essential requirements
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Wireless / radio
HAKOM radio-equipment market access (Pravilnik o radijskoj opremi, NN 49/2016)
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Metrology
DZM legal-metrology type examination and verification
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
Environmental / battery
WEEE producer responsibility through the Environmental Protection and Energy Efficiency Fund
Maintained as a mandatory pre-market route.
No supporting source association
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.
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 Croatia 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 Croatia?
- 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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