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 MALMED device registration and parallel-import authorisation in North Macedonia?
Describe your device to check whether MALMED device registration and parallel-import authorisation 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 MALMED device registration and parallel-import authorisation 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.
Чл. 131 of the Закон за лековите и медицинските средства requires a medical device that is placed on the market in North Macedonia to be entered in the register of medical devices that MALMED keeps, and the 151/2010 rulebook governs the application and the dossier. For an imported device the Law adds two further national gates. Чл. 124 provides that an importer of a device whose manufacturer is not established in the country assumes the manufacturer's duties, and чл. 132 requires the outer and inner packaging to be marked, and the instructions for use to be written, in the Macedonian language and its Cyrillic script. Чл. 131-а creates a separate parallel-import route: the applicant files the parallel-import form ПУМПС, and the device may be placed on the market only under an approval issued by the Agency. A device imported for a health institution follows the parallel route in чл. 131-б.
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
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
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.
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)
Обрасци за медицински средства — the class-specific registration forms and the parallel-import form ПУМПС
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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