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 ALMBIH entry in the Register of medical devices in Bosnia and Herzegovina?
Describe your device to check whether ALMBIH entry in the Register of medical devices 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 ALMBIH entry in the Register of medical devices 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.
Entry in the Agency's Register is the market gate for the whole territory of Bosnia and Herzegovina. Čl. 65(5) of the Pravilnik requires the application to be filed by a manufacturer with a seat in BiH or by a legal person representing a foreign manufacturer and seated in BiH; čl. 65(6) requires the representative to hold a manufacturer's authorisation or a representation contract registered with the state Ministry of Foreign Trade and Economic Relations; čl. 65(7) requires evidence of product-liability insurance valid on the territory of BiH; čl. 65(8) makes the entry the act conferring the right to place the device on the market; čl. 65(9) requires the certificate of entry within 90 days of a complete application, with no appeal but with an administrative dispute available; and čl. 108(2) of the Law forbids marketing a device not entered in that register. The Agency's current documentation list was read in full.
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
Radiation
DARNS ionizing-radiation and nuclear safety
Applies to the facility, operator, or installation rather than only the product.
Source association reviewed
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
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?
Keep researching this market
More Bosnia and Herzegovina medical device resources
Continue with this market