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 DARNS ionizing-radiation and nuclear safety in Bosnia and Herzegovina?
Describe your device to check whether DARNS ionizing-radiation and nuclear safety 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 DARNS ionizing-radiation and nuclear safety 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 equipment
- Maintained rule status
- mandatory for use site
- Useful product facts
- X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.
The Državna agencija za radijacijsku i nuklearnu sigurnost (DARNS) is the state authority for radiation and nuclear safety; its own competence page states that the Agency's competences are prescribed by čl. 8 of the Zakon o radijacijskoj i nuklearnoj sigurnosti u Bosni i Hercegovini, and it publishes the legislation it administers. A medical device containing a radiation source engages DARNS in addition to ALMBIH. The statute itself was not read, so the binding is a candidate.
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 Bosnia and Herzegovina routes to check
Product-specific
BiH technical requirements for products and conformity assessment
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Electrical safety
ANNT electrical-equipment safety ordinance
Evidence is normally handled inside the medical-device registration route.
No supporting source association
EMC
ANNT electromagnetic-compatibility ordinance
Evidence is normally handled inside the medical-device registration route.
Source association awaiting review
Wireless / radio
RAK radio-equipment market access
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Telecom terminal
RAK telecommunications network attachment
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Metrology
Legal metrology — Federation of BiH verification certificate
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Environmental / battery
Federation of BiH waste and waste-battery rules
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Import CoC / PVoC
ALMBIH entry in the Register of medical devices
Handled as an import or shipment-level obligation.
Source association reviewed
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 Bosnia and Herzegovina 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 Bosnia and Herzegovina?
- 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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