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 DRS licence for activity with ionizing-radiation sources in North Macedonia?
Describe your device to check whether DRS licence for activity with ionizing-radiation sources 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 DRS licence for activity 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 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 Дирекција за радијациона сигурност (DRS) is the independent state-administration body with legal personality that carries out administrative and expert work in the field of radiation protection, and it is the licensing authority for the use of ionizing-radiation sources. Чл. 7 of the Закон за заштита од јонизирачко зрачење и радијациона сигурност provides that a legal person may begin work only after obtaining a licence from the Directorate and after entry in the single register of legal persons carrying on activity with ionizing-radiation sources; the licence is issued on application for a definite period of up to five years depending on the categorisation of the radioactive sources, and every change in the conditions for carrying on the activity requires a fresh licence and a fresh entry in the register. The Directorate's own site states that it operates a duty telephone for reporting practices that work without a licence issued by it, and its rulebook index carries the Правилник за формата и содржината на образецот на барањето за издавање на дозволата за вршење на дејност со извори на јонизирачко зрачење (Сл. весник на РМ бр. 157/09, amended Сл. весник на РСМ бр. 124/21). A facility that uses a medical device containing a radiation source therefore needs a DRS licence in addition to the MALMED registration.
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 North Macedonia routes to check
Electrical safety
North Macedonian electrical-safety evidence in the device registration dossier
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
EMC
North Macedonian electromagnetic-compatibility evidence in the device registration dossier
Evidence is normally handled inside the medical-device registration route.
Source association reviewed
Wireless / radio
AEK radio-equipment opinion for non-harmonised frequency bands
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Telecom terminal
AEK telecommunications terminal equipment conditions
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Metrology
Bureau of Metrology — verification of measuring instruments
Applies when the product, feature, component, or use is in scope.
Source association reviewed
Environmental / battery
Extended producer responsibility for waste electrical and electronic equipment and for waste batteries
Applies when the product, feature, component, or use is in scope.
Source association awaiting review
Import CoC / PVoC
MALMED device registration and parallel-import authorisation
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.
Дирекција за радијациона сигурност (DRS)
Закон за заштита од јонизирачко зрачење и радијациона сигурност (пречистен текст), чл. 1, 7 and 8
Дирекција за радијациона сигурност (DRS)
Правилници — including the Правилник за формата и содржината на образецот на барањето за издавање на дозволата за вршење на дејност со извори на јонизирачко зрачење (Сл. весник на РМ бр. 157/09, amended Сл. весник на РСМ бр. 124/21)
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 North Macedonia 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 North Macedonia?
- 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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