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Does my medical device need Radiation and legal-metrology authorization in Albania?

Describe your device to check whether Radiation and legal-metrology authorization 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 Radiation and legal-metrology authorization check is screening

Separates product, supplier, import, facility, source-holder, and operator radiation obligations. Applies when the product, feature, component, or use is in scope.

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: product and use site
Maintained rule status: mandatory if feature
Useful product facts: X-ray or radioactive source, modality, energy, import purpose, installation site, and operator role.

Law 89/2014 Art. 7(2)-(3): devices emitting ionizing or non-ionizing radiation may be placed on the market only if they meet the radiation-protection legislation in force, and devices that are also machinery must additionally meet machinery safety requirements; AKBPM inspectors may order device tests and take samples (Art. 27(1)(c)/(ç)).

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 Albania routes to check

Check every Albania route →

Electrical safety

Medical electrical and EMC evidence

Evidence is normally handled inside the medical-device registration route.

No supporting source association

Wireless / radio

AKEP radio equipment conformity notification/recognition

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.

AKBPM

Law 89/2014 radiation and machinery overlay, inspector testing powers

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 Albania 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 Albania?: 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.