MALMED · Europe

North Macedonia medical device regulatory resources

Every North Macedonia dataset, comparison, and AI workpaper we maintain — one entry point for the whole market.

5 free resources24/25 topics with records6 regulations trackedSep 2026 fees reviewed

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Additional certification and licence checker

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Government registration fees

Review current MALMED application, review, and renewal fees.

Registration timeline

Compare official and realistic approval times by device class and pathway.

Browse North Macedonia's official medical-device instruments — the consolidated Law on Medicines and Medical Devices, the application and documentation rulebook, and the adverse-event, fee and amending rulebooks — with citeable Macedonian passages.

Structured regulatory requirements

Explore all 60 source-linked facts →

24 of 25 research dimensions currently covered · 21 official sources · latest verification 2026-09-16

Market entry

D01

Authority & regime

Verified

MALMED is the national medicines-and-devices agency, a self-standing state-administration body with legal personality: The competent authority for medical devices in North Macedonia is the Agency for Medicines and Medical Devices (Агенција за лекови и медицински средства), established by Article 3 of the La…
Operational name and abbreviation: MALMED / МАЛМЕД, international name 'Macedonian Agency for Medicines and Medical Devices': The full national name is Агенција за лекови и медицински средства; the name used in international legal traffic is 'Macedonian Agency for Medicines and Medical Devices'; the official abbre…

3 source-linked facts

Checked 2026-09-16

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D02

Legal basis & guidance

Verified

Governing act is the Law on Medicines and Medical Devices (not a standalone law on medical devices), Сл. весник на РМ 106/07 as amended to Сл. весник на РСМ 267/25: Medical devices in North Macedonia are governed by the Law on Medicines and Medical Devices (Закон за лековите и медицинските средства), one act covering both medicines and devices. It was…
The 88/15 amendment renamed the act from medical aids to medical devices: The act was adopted in 2007 as the Law on Medicines and Medical Aids (Закон за лековите и медицинските помагала) and was renamed to the Law on Medicines and Medical Devices (Закон за лекови…

2 source-linked facts

Checked 2026-09-16

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D03

Device definition & scope

Verified

The Law itself defines 'медицинско средство' and the in vitro diagnostic device term in Член 2, точки 49 и 50: The definitions of a medical device and of an in vitro diagnostic medical device in North Macedonia are statutory, not merely guidance: Член 2 of the Закон за лековите и медицинските средст…

1 source-linked fact

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D04

Classification rules

Verified

Risk classes of the Law on Medicines and Medical Devices: Class I, Class II-а, Class II-б, Class III

1 maintained scheme · 4 related facts

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D05

Registration pathways

Verified

Four class-specific application forms: Образец бр. 1 (class I), бр. 2 (IIa/IIb/III), бр. 3 (IVD), бр. 4 (AIMD): Registration applications are made on four prescribed forms: form No. 1 for class I devices, form No. 2 for class IIa, IIb and III devices, form No. 3 for in vitro diagnostic devices and fo…
Separate registers for manufacturers and for wholesale/retail legal entities, each with its own entry conditions: Manufacturers of medical devices must report their activity to the Agency before starting manufacture and be entered in the register of manufacturers of medical devices; wholesale of medica…

4 source-linked facts

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D06

Reliance & recognition

Verified

An EU-recognised notified body's EC certificate opens an abridged national dossier route, but the national registration decision is still taken: statement: North Macedonia recognises conformity assessment performed through institutions recognised in the European Union. A device whose conformity is assessed by a notified body recogni…
No route exists for non-EU approvals (FDA, PMDA, MFDS, NMPA and similar): statement: An approval from a regulator outside the European Union gives no market access route and no abridgement in North Macedonia. The Law recognises conformity assessment only through…

5 source-linked facts

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D07

Economic-operator roles

Verified

The registration applicant declares itself as manufacturer, authorised representative or representative, and an EU-seated authorised representative is named for non-EU manufacturers: The device registration form requires the applicant to state the capacity in which it applies — manufacturer (Производител), authorised representative (Застапник) or representative (Претста…
For a foreign-manufactured device the importer into North Macedonia assumes the manufacturer's duties: Where a medical device is manufactured abroad, the duties the Law places on the manufacturer are assumed by the importer of the device into North Macedonia. This makes the domestic importer…

3 source-linked facts

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D08

Establishment, import & distribution

Verified

Wholesale operators and specialised retail shops need the applicable register entry before starting: The Law defines circulation of medical devices as comprising import, export, wholesale and retail. Wholesale may be carried on only by a legal entity entered in the Agency's register of leg…
Import is controlled by pharmaceutical inspectors together with customs officers at the border: Medical devices are imported through a controlled border procedure: customs officers, together with pharmaceutical inspectors, exercise inspection at import, and the pharmaceutical inspecto…

2 source-linked facts

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D09

Dossier requirements

Verified

The device registration application comprises a cover letter, the class-specific form, insurance, the Article 7 or Article 8 documentation, proof of fee payment and samples: An application to register a medical device is filed on the class specific form and contains a cover letter, data on the applicant and the manufacturer, a certificate of the insurance polic…
Devices holding an EC certificate file the short documentary set; devices without one file full quality, safety and efficacy data and an Agency efficacy opinion: Where the device holds an EC certificate of conformity the dossier contains six items: the manufacturer's declaration of conformity, the EC certificate (except for class I devices and gener…

3 source-linked facts

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D10

Official forms & portals

Verified

MALMED publishes the class-specific device registration forms and the parallel-import application form online: MALMED publishes the medical device application forms for download: Образец бр. 1 (class I devices), Образец бр. 2 (classes IIa, IIb and III), Образец бр. 3 (in vitro diagnostic devices), О…

1 source-linked fact

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Submission & evidence

D11

Label, IFU & language

Verified

Devices in circulation must be labelled in Macedonian Cyrillic and carry instructions for use in Macedonian Cyrillic: Medical devices in circulation must be marked in accordance with the Law on the outer and contact packaging in the Macedonian language and its Cyrillic script, and must contain instructions…
The mandatory label content is enumerated in the Law and includes an identification code and the standard device marks: The Law enumerates the information that must appear on a device label: the name and address of the manufacturer and of the importer, the identification data of the device, the marks for ste…

2 source-linked facts

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D12

QMS, audit & inspection

Verified

An EN ISO 13485 quality-system certificate is a mandatory dossier document for every registered device: The device registration dossier must contain a certificate for the EN ISO 13485 quality management system, in both documentation routes: for a device holding an EC certificate, and for a de…
Pharmaceutical inspectors may follow the manufacturer's quality-control system, order conformity assessment, take samples and ban manufacture or placing on the market: The Law gives MALMED's pharmaceutical inspectors a set of powers over medical devices: to inspect the manufacturer's quality control system, to order an assessment of conformity by an autho…

2 source-linked facts

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D13

Standards, testing & ancillary approvals

Unresolved

North Macedonian electrical-safety evidence in the device registration dossier: Electrical safety
North Macedonian electromagnetic-compatibility evidence in the device registration dossier: EMC
AEK radio-equipment opinion for non-harmonised frequency bands: Wireless / radio

8 maintained overlays · 1 related fact

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D14

Fees

Verified

Register entry — medical device of class I: EUR 300
Register entry — medical device of class II-а: EUR 400

18 maintained fee lines · 4 related facts

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D15

Review clocks

Verified

Class I — entry in the register of medical devices · Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 1, with the documentation prescribed by чл. 7 of the 151/2010 rulebook for devices holding an EC certificate of conformity or by чл. 8 for devices without one: 30 days
Class II-а — entry in the register of medical devices · Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook: 30 days
Class II-б — entry in the register of medical devices · Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook: 30 days

7 maintained pathways · 3 related facts

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D16

Approval validity & renewal

Verified

Renewal must be applied for at least 90 days before expiry and repeats the documentary set: Renewal of a device registration must be applied for at the latest 90 days before the registration expires. The renewal documentation consists of the updated administrative data together wi…
Registration runs with the EC certificate for EC-certified devices, and otherwise for 3, 2 or 1 years by class: The registration of a device that holds an EC certificate is valid for as long as the EC certificate or the manufacturer's EC declaration of conformity is valid. For devices without an EC c…

2 source-linked facts

Checked 2026-09-16

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Lifecycle & post-market

D17

Change control

Verified

Changes to a registered device require an amendment application naming one of fourteen enumerated changeable items: New findings on the quality, safety or efficacy of a registered medical device are notified by filing an amendment application, and the rulebook enumerates fourteen changeable items: the ma…
Changes to a parallel-imported device must be notified within 60 days of taking effect in the source country: The holder of a parallel import approval must follow all changes that occur to the device in the country from which it is imported and notify the Agency within 60 days of the date the chang…

3 source-linked facts

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D18

UDI, listing & traceability

Verified

Traceability rests on the label identification code, the register device list and wholesale receipt/storage/dispatch records — no UDI-DI or EUDAMED duty: Traceability of medical devices in North Macedonia rests on national instruments rather than on a UDI system: the identification code that must appear on the device label (Article 132(2)),…

1 source-linked fact

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D19

Clinical investigation & performance

Verified

Clinical investigations may be run only by an authorised legal entity, on Helsinki principles, with written revocable informed consent and subject insurance: A clinical investigation of a medical device may be conducted only by a legal entity that meets the prescribed conditions as to premises, equipment and staff and the requirements of good cl…
The sponsor's pre-investigation notification to MALMED carries the device data, safety results, protocol, ethics opinion and consent documents: Before a clinical investigation begins the sponsor must notify the Agency, and the notification must contain the data on the medical device under investigation, the results of the safety an…

2 source-linked facts

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D20

Special access & derogation

Verified

A healthcare institution may parallel-import medical devices exclusively for its own needs and may not place them on the market: By way of derogation, a healthcare institution may parallel import medical devices exclusively for its own needs. It may not place those devices on the market, but it may, with the prior co…

1 source-linked fact

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D21

Manufacturer PMS

Verified

A device marketing-authorisation holder must organise a materiovigilance system run by an employed responsible person from the health field: The holder of an authorisation to place a medical device on the market must organise a materiovigilance system for its devices, run by an employed person responsible for materiovigilance wh…
Authorisation holders submit periodic device safety reports referenced to a Data lock point: The holder of the authorisation to place a medical device on the market submits periodic safety reports for its devices, referenced to a Data lock point (DLP) defined in the rulebook, and t…

2 source-linked facts

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D22

Vigilance & incident reporting

Verified

Serious unexpected clinical-investigation reactions with death or life-threatening outcome are reported within 24 hours with a full report in 7 days: For a medical device under clinical investigation, a serious unexpected adverse reaction that causes death or is life threatening must be reported within 24 hours as an initial report, with…
MALMED exchanges materiovigilance information with competent authorities in other countries: The materiovigilance rulebook provides for the exchange of materiovigilance information with the competent authorities of other countries, which is how MALMED receives and forwards incident…

3 source-linked facts

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D23

Recall, FSCA & market surveillance

Verified

Device offences carry penalties scaled by entity size: 2,500-3,000 EUR (micro), 5,000-6,000 (small), 15,000-18,000 (medium), 25,000-30,000 (large), plus personal fines: Breach of the device provisions of the Law — including labelling and instructions for use contrary to Article 132 — is punishable by a fine scaled to the size of the legal entity: 2,500 to…
The inspector may temporarily withdraw or seize a device, order destruction, ban import and ban the entity's work for up to six months: Market surveillance is exercised through the pharmaceutical inspector's measures: a ban of up to six months on manufacture, testing or placing on the market, an order to align operations wi…

3 source-linked facts

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D24

Advertising, claims & promotion

Verified

The Law's medicine-advertising rules apply to medical devices, and devices used only in health institutions may not be advertised: The provisions of the Law's advertising chapter that govern the advertising of medicines apply correspondingly to the advertising of medical devices. Advertising of medical devices used onl…
Informing the general public about a device requires prior approval from MALMED and must follow the patient leaflet objectively: MALMED requires that a marketing authorisation holder or manufacturer informing the general public about a medical device that may be sold without a prescription do so only with prior appro…

2 source-linked facts

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D25

Submission communications & appeal

Verified

Filings are made in writing in one copy, and photocopies are accepted with a written statement that they match the originals: Documentation in the device registration procedure is submitted in writing in one copy. Photocopies are accepted, provided the applicant files a written statement confirming that the copies…

1 source-linked fact

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Government fees

Full fee schedule (18 lines) →

Агенција за лекови и медицински средства (MALMED) registration fees in EUR · reviewed 2026-09-16

Fee line	Amount	Provenance
Register entry — medical device of class I	EUR 300	Verified
Register entry — medical device of class II-а	EUR 400	Verified
Register entry — medical device of class II-б	EUR 400	Verified
Register entry — medical device of class III	EUR 500	Verified

14 more fee lines on the full schedule · 18 of 18 rows source-verified

Registration timeline

Full registration timeline →

Агенција за лекови и медицински средства (MALMED) (MALMED) review clocks and planning ranges · 4-class (I, II-а, II-б, III) under чл. 110 of the Law on Medicines and Medical Devices, with in vitro diagnostic devices on the separate List А, List Б, self-diagnosis and other axis under чл. 113. This is the country's own national ladder; North Macedonia is an EU candidate country and applies neither Regulation (EU) 2017/745 nor Regulation (EU) 2017/746. classification

Class / pathway	Review clock	Planning total	Provenance
Class I — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 1, with the documentation prescribed by чл. 7 of the 151/2010 rulebook for devices holding an EC certificate of conformity or by чл. 8 for devices without one)	30 days	2-4 months	Verified
Class II-а — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook)	30 days	2-4 months	Verified
Class II-б — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook)	30 days	2-4 months	Verified
Class III — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2, or on Образец бр. 4 for an active implantable medical device)	30 days	2-4 months	Verified

3 more pathways on the full timeline · 7 of 7 clocks source-linked

1Pre-Submission Preparation(1-3 months)
2Application Submission(1-2 weeks)
3Administrative Review(2-4 weeks)
4Technical Evaluation(30 days)
5Registration Approval(1-2 weeks)

Key regulations

All 6 North Macedonia regulations →

Official MALMED rules and guidance · 6 of 6 documents linked to official sources

„Службен весник на РМ“ бр. 100 од 23.05.2016Правилник за начинот за известување на несаканите ефекти за време на користењето на медицинското средство (Rulebook on materiovigilance — the reporting of adverse effects during the use of a medical device)

VigilanceVerified

„Службен весник на РМ“ бр. 188 од 02.11.2015Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства (Rulebook on fees and costs payable in proceedings under the Law on Medicines and Medical Devices)

RegistrationVerified

„Службен весник на РСМ“ бр. 110 од 22.5.2026Правилник за изменување и дополнување на Правилникот за надоместоците и висината на трошоците (Amending rulebook 110/2026)

RegistrationVerified

„Службен весник на РСМ“ бр. 86 од 28.4.2025Правилник за изменување на Правилникот за надоместоците и висината на трошоците (Amending rulebook 86/2025 — replaces Article 11, the device register fees)

RegistrationVerified

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