Product approval
A certificate or approval attached to the finished product, component, or radio host.
Free · No signup · Official source linksNorth Macedonia medical device certification and licence checker
Check North Macedonia requirements beyond medical-device classification, including radio, electrical, metrology, radiation, import, environmental, and product-specific routes.
8 maintained routes11 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.
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
Medical device certification routes in North Macedonia
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
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
Official starting points
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.
Агенција за лекови и медицински средства (MALMED)
Закон за лековите и медицинските средства – неофицијален пречистен текст (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25)
Агенција за лекови и медицински средства (MALMED)
Правилник за содржината на образецот на барањето и потребната документација … за запишување на медицинските помагала во регистерот на медицински помагала, Сл. весник на РМ бр. 151 од 22.11.2010, чл. 7, 8 and 22
Агенција за лекови и медицински средства (MALMED)
Обрасци за медицински средства — the class-specific registration forms and the parallel-import form ПУМПС
Агенција за електронски комуникации (AEK)
Радио опрема — AEK competence over radio equipment in non-harmonised frequency bands, under чл. 76 ст. 3 of the Закон за електронските комуникации
Агенција за електронски комуникации (AEK)
Правилник за радио опрема и телекомуникациска терминална опрема
Биро за метрологија
Закон за метрологија – консолидиран текст (Сл. весник на РМ 55/02 … Сл. весник на РСМ 147/24), чл. 3, 4, 21-23, 26 and 27
Биро за метрологија
Закони — the Bureau's index of the metrology legislation it administers
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)
Министерство за животна средина и просторно планирање (MoEPP)
Жиро сметки — Отпад: the charging articles of the WEEE, batteries and extended-producer-responsibility statutes
Министерство за животна средина и просторно планирање (MoEPP)
Управување со отпадот — the waste-management regulation index
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
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