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 AEK radio-equipment opinion for non-harmonised frequency bands in North Macedonia?
Describe your device to check whether AEK radio-equipment opinion for non-harmonised frequency bands 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 AEK radio-equipment opinion for non-harmonised frequency bands check is screening
Checks Wi-Fi, Bluetooth, cellular, NFC, RFID, UWB, telemetry, and proprietary radio approval. 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
- Radio and spectrum approval
- Regulatory object
- radio equipment
- Maintained rule status
- mandatory if feature
- Useful product facts
- Radio technologies, bands, power, antenna, module model, approval IDs, and host integration changes.
Radio equipment placed on the North Macedonian market is governed by the Правилник за радио опрема и телекомуникациска терминална опрема, adopted under the Закон за електронските комуникации. The Agencija za elektroniski komunikacii (AEK) states on its own radio-equipment page that under чл. 76 ст. 3 of the Law and that rulebook its competence is limited to radio equipment put into use in frequency bands whose use is not harmonised across the whole territory of the European Union; for such equipment the manufacturer, its authorised representative or the person responsible for placing it on the market files a Пријава with AEK, and if AEK's opinion is positive the procedure continues with the competent institutions under the rulebook. A medical device that contains a radio transmitter or receiver and uses a non-harmonised band therefore needs an AEK opinion in addition to its MALMED registration; a device that is not radio equipment carries no AEK obligation. The rulebook and the accompanying application form were retrieved as documents from AEK's own site.
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
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
Radiation
DRS licence for activity with ionizing-radiation sources
Applies to the facility, operator, or installation rather than only the product.
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.
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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