MALMED · structured requirements

🇲🇰 North Macedonia medical device regulatory data

Explore the medical device requirements currently available for North Macedonia, organized by topic and linked to official sources.

60 facts25 dimensions12 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

Which claims, audiences, channels, approvals, and restrictions apply?

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The Law's medicine-advertising rules apply to medical devices, and devices used only in health institutions may not be advertised

advertising.medicine-advertising-rules-applied-to-devices

Fact-level verified

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 only in health institutions is prohibited. The Director of the Agency prescribes the methods of advertising medical devices and the fee for assessing the advertising documentation.

Conditions

The prohibition is absolute for devices used only in health institutions, so professional-use devices cannot be promoted to the public.
Because the medicine advertising rules apply, the general-public route is limited to devices that may lawfully be advertised to the public, and the documentation is assessed by the Agency for a fee.

Macedonian. Article 139: 'Одредбите од Главата III.7. на овој закон, што се однесуваат на огласувањето на лековите, се применуваат соодветно на огласувањето на медицинските средства.' and 'Се забранува огласување на медицински средства што се користат само во здравствени установи.'

Informing the general public about a device requires prior approval from MALMED and must follow the patient leaflet objectively

advertising.public-information-requires-prior-agency-approval

Fact-level verified

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 approval from the Agency, and that the information be presented objectively and in accordance with the patient leaflet.

Conditions

The prior approval of the Agency is the operative condition for public-facing information about an OTC device.
The content rule is objective presentation consistent with the patient leaflet, which ties the advertising text back to the approved Macedonian instructions for use.

Macedonian. The Agency's advertising page states that informing the general public about devices sold without prescription is permitted 'по претходно одобрение од Агенцијата', objectively and in line with the patient leaflet. This is the Agency's published position on Article 139 of the Law.

Approval validity & renewal

What expires, what is retained periodically, and when must renewal start?

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Renewal must be applied for at least 90 days before expiry and repeats the documentary set

renewal.application-90-days-before-expiry-with-updated-documents

Fact-level verified

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 with the manufacturer's declaration of conformity, the EC certificate, the EN ISO 13485 certificate, the free-sale certificate and the insurance policy.

Conditions

The 90-day window is a filing deadline, not a decision clock: the rulebook fixes no period within which the Agency decides a renewal.
Because the renewal set mirrors the Article 7 documentation, an EC-certified device renews on the same short documentary basis as it registered.

Effective from 2010-11-30

Macedonian. Article 17 sets the 90-day pre-expiry filing requirement; Article 20 lists the renewal documentation. The rulebook is a 2010 sub-legal act still published by MALMED as the applicable device registration rulebook.

Registration runs with the EC certificate for EC-certified devices, and otherwise for 3, 2 or 1 years by class

validity.registration-term-ec-linked-or-3-2-1-years

Fact-level verified

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 certificate the registration is time-limited by class: three years for class I, class II-a and IVDs including self-testing, two years for class II-b and List B IVDs, and one year for class III, active implantable devices and List A IVDs.

Conditions

The EC-linked term ties the validity of the North Macedonian registration directly to the continued validity of the European certificate, so a lapsed EC certificate removes the basis of the registration.
The 151/10 rulebook is a 2010 sub-legal act adopted under the predecessor statute title and still published by MALMED as the applicable device registration rulebook; the class-based terms therefore reflect the MDD/AIMDD/IVDD class scheme.
A parallel-import approval has its own two-year term (Article 131-а) and is not governed by Article 22.

Effective from 2010-11-30

Macedonian. Article 22 of the 151/10 rulebook distinguishes the EC-certificate-linked term from the class-based terms for devices without an EC certificate.

Authority & regime

Which authority and binding regime govern this product, task, and date?

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MALMED is the national medicines-and-devices agency, a self-standing state-administration body with legal personality

authority.competent-authority-establishment-and-status

Fact-level verified

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 Law on Medicines and Medical Devices as an independent state-administration organ with the status of a legal person, seated in Skopje.

Macedonian. Article 3 creates the Agency; the same article fixes its seat in Skopje and its status as 'самостоен орган на државната управа со својство на правно лице'. The Law governs both medicines and medical devices, so the device competent authority is the same body.

Operational name and abbreviation: MALMED / МАЛМЕД, international name 'Macedonian Agency for Medicines and Medical Devices'

authority.official-international-name-and-abbreviation

Fact-level verified

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 abbreviation is МАЛМЕД. Filings and correspondence should use MALMED / МАЛМЕД.

Macedonian. This is the authority's own statutory self-designation, so the registry label 'MALMED' is the correct operational abbreviation; the international name is the long form to quote to a counterparty. The earlier name of the agency (pre-2015) was Агенција за лекови.

MALMED supervises the Law and inspects through pharmaceutical inspectors, with customs officers at import and compulsory joint inspections of large wholesalers

authority.supervision-and-inspection-mandate

Fact-level verified

Supervision over the implementation of the Law is exercised by MALMED; inspection is carried out by MALMED through pharmaceutical inspectors. At import, inspection is carried out by customs officers together with pharmaceutical inspectors. Wholesalers whose total turnover exceeded 10,000,000 denars in the previous year are subject to a compulsory joint control each year by at least two pharmaceutical inspectors, two tax inspectors and one customs officer.

Macedonian. Article 141 is the general supervision article; Article 153 applies the medicines inspection chapter to medical devices and enumerates the device-specific inspector powers.

Change control

Does the event require internal documentation, notice, prior approval, transfer, or a new application?

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Changes to a registered device require an amendment application naming one of fourteen enumerated changeable items

change.amendment-application-and-enumerated-changeable-items

Fact-level verified

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 manufacturer's name or address; the applicant's name or address; the applicant; the device name; the manufacturer of input components; a new place of manufacture for part or all of the production process named in the certificate; the finished-product testing procedure (standards and methods); the appearance and manner of outer or inner labelling; the shape, packaging or dimensions of the device; the class; the shelf life; the storage conditions; the manner of dispensing or selling; and the place of dispensing or selling. Where the documentation filed under Article 7 or Article 8 at first registration is unchanged, the applicant may refer to it instead of resubmitting.

Conditions

The change fee is 40 per cent of the registration fee for a variation, and 10 EUR for a minor variation notified as part of the technological process (Article 11 as replaced by the 86/25 amendment).
The amendment application is a cover letter, the completed amendment form for the class, documentation on the change sufficient for its assessment, and proof of fee payment (Article 14).

Effective from 2010-11-30

Macedonian. Articles 12 to 16 of the 151/10 rulebook govern changes; Article 13 enumerates the changeable items and Article 16 allows reference back to the original documentation where unchanged. The rulebook is a 2010 sub-legal act still published by MALMED as the applicable device registration rulebook.

Changes to a parallel-imported device must be notified within 60 days of taking effect in the source country

change.parallel-import-change-notification-60-days

Fact-level verified

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 change enters into force in that country, attaching proof from the competent authority of the source country that the change has been approved.

Conditions

The 60-day period runs from entry into force in the source country, not from the holder's own knowledge.
Withdrawal of the device from circulation in the source country must be notified within 15 days and causes the Agency to revoke the parallel-import approval.

Macedonian. Article 131-а(8) sets the 60-day change-notification duty and the accompanying proofs for a parallel-imported device; it is a distinct change-control regime from the Article 12-16 rulebook procedure for nationally registered devices.

Registered operators must keep their register data current, and the register records the device list and classification

change.registration-data-update-duties

Fact-level verified

An economic operator entered in one of MALMED's registers must keep the registered data up to date: registered manufacturers, wholesalers and specialised shops must regularly update the information submitted and file documentation on all changes affecting public health. Submitting false data, a false statement or false proof in the procedure for entering a medical device in the register of medical devices, or in the procedure for obtaining a parallel-import approval, is a criminal offence.

Conditions

Submitting false data, a false statement or false proof in the procedure for entering a medical device in the register, or in the procedure for obtaining a parallel-import approval, is punishable by six months to five years of imprisonment (Article 156-ѓ, first article so numbered).
A change to the device also triggers the amendment procedure under the 151/10 rulebook where the registered particulars are affected.

Macedonian. Article 128 enumerates the register data for wholesale entities including the device list and classification; Article 156-ѓ makes a false statement in the register-entry or parallel-import procedure a criminal offence carrying six months to five years.

Classification rules

What local class follows from which rules and decisive product facts?

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Third axis: transient (<60 minutes), short-term (up to 30 days), long-term (over 30 days)

classification.duration-of-use

Fact-level verified

By duration of use in humans devices are classified as transient (used continuously for less than 60 minutes), short-term (used continuously for up to 30 days) and long-term (used continuously for more than 30 days).

Macedonian.

IVDs: Lists A and B for professional use, self-testing devices, and all others

classification.ivd-lists-a-and-b-and-self-testing

Fact-level verified

In vitro diagnostic devices are classified as IVDs used exclusively by professionals and classified according to the type of device into List A and List B; IVDs for self-diagnosis; and all other IVDs.

Macedonian. The IVD class distinction drives both the dossier route (risk analysis is required for List A and List B products under Article 8 of the 151/10 rulebook) and the registration validity period (List A one year, List B two years under Article 22 of the same rulebook) and the fee (List A and List B 300 EUR, self-testing 200 EUR, all others 400 EUR under the 86/25 amendment).

Second axis: non-invasive, invasive, active

classification.nature-of-device-invasiveness-and-activity

Fact-level verified

By their nature, power source and other characteristics devices are classified as non-invasive, invasive and active.

Macedonian. Classification conditions and the manner of classifying devices are prescribed by the Director of the Agency under Article 115; the device classification rulebook listed by MALMED is Правилник за поблиските услови и начинот на класифицирање на медицинските помагала, Сл. весник на РМ бр. 125/08.

Four risk classes: I, II-a, II-b, III

classification.risk-classes-i-to-iii

Fact-level verified

Medical devices are classified by potential risk to users as class I (low risk), class II-a (high risk), class II-b (higher risk) and class III (highest risk).

Macedonian. The Law uses the older four-class MDD scheme, not MDR's four classes with a different rule set; the drafting of class II-a ('висок потенцијал на ризик') is the Law's own wording.

Clinical investigation & performance

Which clinical or IVD performance evidence or study is required and accepted?

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Clinical investigations may be run only by an authorised legal entity, on Helsinki principles, with written revocable informed consent and subject insurance

clinical.investigation-authorisation-and-ethics-conditions

Fact-level verified

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 clinical practice, and that is authorised by the Director of the Agency. The investigation must be conducted in accordance with the Declaration of Helsinki, the subject must give written informed consent which may be revoked at any time, and the subjects must be insured for the investigation.

Conditions

The sponsor must notify the Agency before starting; the Agency's silence for 30 days is a tacit permission (Article 134(3)).

Macedonian. Article 133 sets the authorisation conditions, the Helsinki standard, the written revocable informed consent and the insurance of subjects. Article 134 adds the notification duty and the tacit-approval rule.

Device definition & scope

Is the product a device, IVD, accessory, software, or borderline product locally?

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The Law itself defines 'медицинско средство' and the in vitro diagnostic device term in Член 2, точки 49 и 50

scope.statutory-definitions-calen-2

Fact-level verified

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 средства ('Одделни поими употребени во овој закон го имаат следново значење:') carries 64 numbered definitions, and точка 49 defines 'Медицинско средство' as any instrument, apparatus, appliance, material or other product used in human medicine which has no pharmacological, immunological or metabolic action and is used alone or in combination, including the software necessary for its correct use, for diagnosis, prevention, monitoring, treatment or alleviation of disease; for diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; for investigation, replacement or modification of an anatomical or physiological process; and for control of conception. The same point adds that medical devices also include materials intended by their manufacturers to be used together with the device to enable its use, materials with specifically designed characteristics made to the written prescription of a qualified person for the individual use of a particular patient (custom-made devices), and materials intended for clinical investigations. Точка 50 defines 'Медицинско средство за in vitro дијагностика' as a medical device comprising reagents, reagent products, reagent kits, control and calibration materials, instruments and apparatus, equipment or systems used alone or in combination and intended for use in in vitro conditions for the examination of biological samples, including tissue samples obtained from the human body, in order to provide information on the physiological or pathological state, on congenital anomalies, to determine compatibility with potential recipients, and to monitor therapeutic measures. The scope of the Law is set by Член 1, which covers medicines and medical devices for human use, the conditions and manner of securing their quality, safety and efficacy, their manufacture, testing, placing on the market, distribution, price formation, quality control, advertising and inspection — so advertising of devices is inside the statutory scope as well. MALMED's own guidance page reproduces the two definitions word for word, with one residue of the pre-2015 wording still visible ('употреба заедно со медицинското помагало'), which shows the page is a copy of the statutory text and not the source of it.

Conditions

The text read is MALMED's unofficial consolidated text (Неофицијален пречистен текст), not the gazette original.
The base act of 2007 was titled 'Закон за лековите и медицинските помагала' (Службен весник на РМ бр. 106/07); the word 'помагала' (aids) was replaced throughout by 'средства' (devices) by the amending act in Службен весник на РМ бр. 88/15, which is why the definitions in the base text read 'Медицинско помагало е …'.
The consolidated text also consolidates the Constitutional Court decision У.бр.121/2014 (Службен весник на РМ 113/15) and the amendments 88/10, 36/11, 53/11, 136/11, 11/12, 147/13, 164/13, 27/14, 43/14, 88/15, 154/15, 228/15, 7/16, 53/16, 83/18, 113/18, 245/18, 28/21, 122/21, 60/23 and 267/25.
Classification and not definition is what Section IV does: Член 110 (classes I, II-а, II-б, III), Член 111 (non-invasive/invasive/active), Член 112 (transient/short-term/long-term) and Член 113 (IVD lists А and Б, self-diagnosis, all others).

Информации за медицински средства (MALMED guidance page carrying the device, IVD, class and dispensing definitions)

Dossier requirements

Which evidence, local deltas, formats, and signatures are required?

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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

dossier.application-components-and-samples

Fact-level verified

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 policy together with a statement, the documentation prescribed by Article 7 for devices holding an EC certificate or by Article 8 for devices without one, and proof that the registration fee has been paid. The Agency may require samples of the device to be submitted with the application.

Conditions

Documentation is submitted in writing in one copy; photocopies are accepted together with a written statement by the applicant confirming that they match the originals (Articles 11 and 21).
The dossier must include a proposed outer and inner label in Macedonian Cyrillic and, for a device of foreign origin, a patient leaflet in English together with a proposed Macedonian instructions-for-use signed by a clinician (form sections II and III).

Effective from 2010-11-30

Macedonian. Article 5 of the 151/10 rulebook enumerates the components of the application and the documentation route split; Articles 11 and 21 govern the written form and copies. The rulebook is a 2010 sub-legal act still published by MALMED as the applicable device registration rulebook.

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

dossier.ec-certificate-route-documentation

Fact-level verified

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 general IVDs), the EN ISO 13485 quality-system certificate, the free-sale certificate from the manufacturer's country, the insurance policy with statement, and the representation contract (or proof of branch / trade-representation status). Where the device has no EC certificate the dossier must additionally contain the administrative data and the full quality, safety and efficacy data, a risk analysis for classes IIb, III and AIMD and for List A and List B IVDs, and, for classes IIa, IIb and III, clinical data or published literature or clinical-investigation results on the basis of which the Agency obtains an expert opinion on the efficacy of the device.

Conditions

The efficacy opinion under Article 10 is prepared and signed by an expert engaged for the Agency and is a separate step on the non-EC route, additional to the register entry decision.
Administrative data on the non-EC route include the GMDN or EDMA device code and the free-sale certificate.
The rulebook is a 2010 sub-legal act; it has not been replaced following the MDR (EU) 2017/745, which does not apply directly in North Macedonia.

Effective from 2010-11-30

Macedonian. Article 7 governs the EC-certificate documentation set and Article 8 the documentation for devices without an EC certificate plus the additional quality, safety and efficacy data; Article 10 provides for the Agency's opinion on efficacy. The Article 7 and Article 8 items are quoted in the two reliance facts above.

The non-EC dossier includes a GMDN or EDMA code; EC-route forms use national category codes

dossier.gmdn-edma-coding-and-administrative-data

Fact-level verified

On the non-EC route the administrative-data block of the dossier under Article 8 identifies the device by its classification under the international nomenclature for medical devices (GMDN or EDMA code) in addition to the applicant's and manufacturer's names and addresses, the free-sale certificate, insurance and representation contract. The Article 7 dossier for devices holding an EC certificate does not require the code; the application forms instead carry a twelve-item national device category code (section IV of the forms).

Conditions

For an IVD the form records the List A / List B / self-testing / other position (Article 4, section 3) instead of the device class.

Effective from 2010-11-30

Macedonian. The administrative data block of Article 8 requires the nomenclature code alongside the identification data. This is separate from the label identification code (EAN/BAR) recorded under udi-listing-traceability.

Economic-operator roles

Which manufacturer, representative, holder, applicant, importer, and distributor roles apply?

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The registration applicant declares itself as manufacturer, authorised representative or representative, and an EU-seated authorised representative is named for non-EU manufacturers

operator.applicant-capacities-and-eu-authorised-representative

Fact-level verified

The device registration form requires the applicant to state the capacity in which it applies — manufacturer (Производител), authorised representative (Застапник) or representative (Претставник) — together with the manufacturer's name and address and the name of the authorised representative in the European Union. A manufacturer seated outside the European Union must name an authorised representative in the EU and supply an EN ISO 13485 certificate; a manufacturer seated inside the European Union supplies the EN ISO 13485 certificate without the EU-representative entry.

Conditions

The form also requires an insurance policy covering the territory of North Macedonia and, for a foreign applicant, a contract with the domestic representative.
An applicant that is not the manufacturer must be a legal entity or a branch or trade representation registered in the country — the Law requires a registered seat for the representative.

Effective from 2010-11-30

Macedonian. The form section I distinguishes 'Производител', 'Застапник' and 'Претставник'; section III requires 'Име на овластен застапник во ЕУ' for a manufacturer outside the EU and the EN ISO 13485 certificate for both cases. The 151/10 rulebook is a 2010 sub-legal act adopted under the predecessor statute title ('медицински помагала'); MALMED still publishes it as the applicable device registration rulebook.

For a foreign-manufactured device the importer into North Macedonia assumes the manufacturer's duties

operator.foreign-manufacturer-duties-assumed-by-importer

Fact-level verified

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 the legally responsible economic operator for a foreign product, alongside the register entry of the manufacturer and of the authorised representative recorded in the registration dossier.

Conditions

The importer must itself be a registered economic operator: wholesale may be carried on only by a legal entity entered in MALMED's wholesale register (Article 126(2)).
The registration application may be filed by the manufacturer, by an authorised representative or by a representative, and the 151/10 form requires the applicant to declare which capacity it holds.
For a manufacturer seated outside the European Union the dossier must additionally name the authorised representative in the EU and carry an EN ISO 13485 certificate.

Macedonian. Article 124: 'Во случај медицинското средство да е произведено во странство, должностите на производителот ги презема увозникот на медицинското средство во Република Македонија.'

Wholesale authorisation is a register entry conditioned on premises, staff and an adverse-effect reporting officer

operator.wholesale-register-entry-conditions

Fact-level verified

Registration to perform wholesale of medical devices is granted to a legal entity that has notified its activity to the Agency, employs an adequate number of staff with higher education in medicine, pharmacy or dentistry, operates a quality system protecting public health, employs a person responsible for monitoring and reporting adverse effects and reactions of medical devices, and trades only in devices that comply with the general and particular conditions and are properly marked. The detailed premises, equipment and staff conditions and the entry documentation are prescribed by the Director of the Agency. The application is decided within 90 days, and the entry records the entity's address, its Central Register certificate and the list of devices it will sell with their classification.

Conditions

The wholesale register entry does not itself authorise a device: to place a particular device on the market the entity still needs the device to be entered in the register of medical devices, or a parallel-import approval.
Wholesalers with annual turnover above 10,000,000 denars are subject to a compulsory joint annual control by at least two pharmaceutical inspectors, two tax inspectors and one customs officer (Article 141(5)).

Macedonian. Article 127 sets the conditions for wholesale and includes the requirement of an employed person responsible for reporting adverse effects; Article 128 enumerates the entry data including the list of devices and their classification; Article 129(1) sets the 90-day notification of the decision on the register entry.

Establishment, import & distribution

Which establishment licences, importer permissions, and distribution controls apply?

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Wholesale operators and specialised retail shops need the applicable register entry before starting

establishment.circulation-activities-and-registers

Fact-level verified

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 legal entities performing wholesale of medical devices, and the activity must be notified to the Agency and the register entry obtained before it begins. Register entry data include the entity's address, its Central Register certificate and the list of devices it will sell with their classification. Retail of medical devices is carried on in pharmacies and/or in specialised shops, and a specialised shop must be entered in the Agency's register of specialised shops before starting the activity.

Conditions

Registration of a manufacturer runs under Article 121 and 123, of a wholesaler under Article 127–129, and of a specialised retail shop under Article 130; each is notified within 90 days (Articles 123(2), 129(1), 130(6)).
Wholesale conditions under Article 127 are: prior notification and register entry, an adequate number of staff with higher education in medicine, pharmacy or dentistry, a quality system, an employed person responsible for monitoring and reporting adverse effects, and compliance with the general and particular conditions; the detailed premises, equipment and staff conditions are prescribed by the Director under Article 129(4).
The wholesale register fee is fixed by the fees rulebook: 471 EUR as amended with effect from 23 May 2026; the specialised-retail-shop entry is 160 EUR.

Macedonian. Article 126(2): 'Прометот на големо со медицински средства можат да го вршат само правни лица кои се запишани во регистарот на правни лица кои вршат промет на големо со медицински средства.' Article 130 provides that retail is performed 'во аптеки и/или специјализирани продавници'.

Import is controlled by pharmaceutical inspectors together with customs officers at the border

establishment.import-control-at-the-border

Fact-level verified

Medical devices are imported through a controlled border procedure: customs officers, together with pharmaceutical inspectors, exercise inspection at import, and the pharmaceutical inspector may prohibit import under the medicines-inspection measures of Article 146, which Article 153(1) applies correspondingly to medical devices. A parallel-imported device additionally requires a parallel-import approval held by a registered wholesaler, and a health institution importing in parallel for its own needs may not place the device on the market.

Conditions

A parallel import requires a temporary or full approval under Article 131-а, or for a healthcare institution the derogation under Article 131-б.
Under Article 153(2)(7) the inspector may seize devices produced or placed on the market by a legal entity that is not entered in the register of manufacturers.

Macedonian. Article 141(4) places customs officers alongside pharmaceutical inspectors in supervising device import; the inspector's measures under Article 146 include banning import.

Fees

What regulator fee applies to this class, route, event, and date?

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Device registration fees are charged per class: 300 EUR (class I), 400 EUR (classes IIa/IIb), 500 EUR (class III) and 200-400 EUR for IVDs

fees.device-registration-per-class-amounts-2025

Fact-level verified

The fee payable to the Agency for entry of a medical device in the register is charged per device class following the 2025 amendment of the fees rulebook, which replaced the former per-product scale: class I 300 EUR, class II-a 400 EUR, class II-b 400 EUR and class III 500 EUR; for in vitro diagnostic devices, List A 300 EUR, List B 300 EUR, self-testing 200 EUR and all other IVDs 400 EUR. Changes (variations) are charged at 40 per cent of the registration fee, and minor variations notified as part of the technological process at 10 EUR.

Conditions

The 2025 amendment was published in Службен весник на РСМ бр. 86 од 28.4.2025 and entered into force on 6 May 2025.
The superseded scale under Article 11 of the 188/15 rulebook charged 40 EUR per product for up to 25 products, 24 EUR per product for up to 100, and 8 EUR per product above 100, and applied to CE-marked and non-CE devices alike.
Parallel-import approvals are not charged under Article 11: their fees remain the per-product scale in Article 3(2) of the 188/15 rulebook.
Fee amounts in this rulebook are denominated in euros and paid in denar counter-value.

Effective from 2025-05-06

Macedonian. The 86/25 amendment states a new Article 11 with the per-class amounts; the amounts quoted are the euro counter-values printed in the amendment. Verified by extracting the text of the published PDF nadomestoci-86-25.pdf from malmed.gov.mk.

Other fixed device charges: 240 EUR clinical investigation, 1,000 EUR manufacturing approval, 1,000 EUR conformity-assessment body authorisation

fees.other-device-charges-investigation-manufacture-assessment

Fact-level verified

Beyond registration, the fees rulebook fixes charges for the other device procedures: 240 EUR for a clinical investigation of a medical device, 240 EUR for an ethics committee opinion and 120 EUR to change a clinical investigation; 1,000 EUR for approval to manufacture medical devices per type, model and place of manufacture, 500 EUR for a partial approval and 100 EUR to change the responsible person; and 1,000 EUR for authorising a body to perform conformity assessment of medical devices.

Conditions

The manufacturing-approval fee of 1,000 EUR is charged per type, model and place of manufacture, so a multi-site manufacturer pays per site.
These articles were not restated by the 86/25 or 110/26 amendments, so the 2015 amounts stand.

Effective from 2015-11-10

Macedonian. Articles 6, 7(2) and 12 item 5 of the 188/15 fees rulebook. Article 6 covers clinical investigations including the ethics committee opinion; Article 7(2) the device manufacture approval; Article 12 item 5 the authorisation of conformity-assessment bodies.

Parallel-import approvals keep the per-product fee scale: 40 EUR per product up to 25, 24 EUR up to 100, 8 EUR above 100

fees.parallel-import-fees-per-product-scale

Fact-level verified

The fee for a parallel-import approval for medical devices remains the per-product scale in Article 3(2) of the fees rulebook, which the 2025 per-class amendment did not touch: 40 EUR per product for up to 25 products, 24 EUR per product for up to 100 products, and 8 EUR per product for more than 100 products. A variation of a parallel-import approval costs 10 EUR where no new approval is needed and 80 EUR where a new approval is required.

Conditions

The 86/25 amendment restated Article 11 (device registration) but left Article 3 unchanged, so the parallel-import scale survives at its 2015 amounts.
The 110/26 amendment changed the wholesale register fee in Article 8 but likewise left Article 3 untouched.

Effective from 2015-11-10

Macedonian. Article 3(2) of Правилникот за надоместоци (Сл. весник на РМ 188/15) sets the per-product scale for parallel-import approval; confirming it was not amended required reading the 86/25 and 110/26 amendments, which restate other articles only.

The wholesale register entry fee is 471 EUR from 23 May 2026, and the specialised retail shop entry is 160 EUR

fees.wholesale-register-entry-471-eur-2026

Fact-level verified

Registration of a legal entity in the register of wholesale traders in medical devices costs 471 EUR following the 2026 amendment to the fees rulebook, which cut the fee from the 500 EUR set in 2015. Registration of a specialised shop for retail of medical devices costs 160 EUR.

Conditions

The 2026 amendment was published in Службен весник на РСМ бр. 110 од 22.5.2026 and entered into force on 23 May 2026.
The same amendment added a new item 7 to Article 8 for wholesale of narcotic drugs and psychotropic substances at 442 EUR.
The 2015 amounts were 500 EUR for wholesale registration and 160 EUR for the specialised shop; only the wholesale figure was amended.

Effective from 2026-05-23

Macedonian. Verified by extracting the text of the published PDF nadomestoci-110-26.pdf from malmed.gov.mk, which restates Article 8 of the fees rulebook.

Label, IFU & language

Which label and IFU elements, languages, symbols, and translation controls apply?

Compare countries

Devices in circulation must be labelled in Macedonian Cyrillic and carry instructions for use in Macedonian Cyrillic

label.macedonian-cyrillic-mandatory-on-devices-in-circulation

Fact-level verified

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 for use written in the Macedonian language and its Cyrillic script. The minimum label content is fixed by the Law: manufacturer and importer details, identification data, the marks for sterile, custom-made, for clinical investigation and single-use devices, the identification code, expiry date, storage conditions, special conditions of use, warnings, and the intended purpose together with other information relevant to public health. A parallel-imported device additionally requires a supplementary Macedonian Cyrillic package label.

Conditions

The language rule is absolute in the Law for devices in circulation: labelling and instructions for use must be in Macedonian Cyrillic; the English patient leaflet required in the dossier is a filing document, not the market label.
The registration dossier must contain the proposed Macedonian Cyrillic outer and inner labelling (rulebook 151/10, Article 7(2)), so the label text is reviewed at registration.
For a parallel import Article 131-а(3)(15) requires a supplementary label carrying the package labelling in Macedonian Cyrillic; the parallel-import holder's details appear in the proposed Macedonian instructions for use (item 13).

Macedonian. Article 132: 'Медицинските средства што се во промет мора да бидат означени во согласност со одредбите на овој закон, на надворешното и контакното пакување на македонски јазик и неговото кирилско писмо и да содржат упатство за употреба.' and 'Упатството за употреба на медицинското средство мора да биде напишано на македонски јазик и неговото кирилско писмо.'

The mandatory label content is enumerated in the Law and includes an identification code and the standard device marks

label.minimum-content-and-identification-code

Fact-level verified

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 sterile devices, custom-made devices, devices intended for clinical investigation and single-use devices, the identification code, the expiry date, storage conditions, special conditions of use, warnings and precautions, and the intended purpose together with any other information relevant to public health. The identification code is required by the label article itself; no UDI-DI or EUDAMED entry is created by this provision.

Conditions

The identification code under Article 132(2) is the device-level code required on the label; a UDI-DI/EUDAMED duty is not established by the Law or by the device rulebooks reviewed (recorded in unresolved).
The 151/10 registration form requires the proposed Macedonian Cyrillic labelling showing these elements to be filed with the application.

Macedonian. Article 132(2) enumerates the label elements and includes 'код за идентификација'. For parallel imports the identification code is specified on the import form as an EAN or BAR code.

Legal basis & guidance

Which current law, regulation, guidance, and transition provisions apply?

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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

legal-basis.governing-act-and-amendment-chain

Fact-level verified

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 adopted as the Law on Medicines and Medical Aids (Закон за лековите и медицинските помагала), Сл. весник на РМ бр. 106/07, and has been amended repeatedly; the amendment chain runs 106/07, 88/10, 36/11, 53/11, 136/11, 11/12, 147/13, 164/13, 27/14, 43/14, 88/15, 154/15, 228/15, 7/16, 53/16, 83/18, 113/18, 245/18, Сл. весник на РСМ 28/21, 122/21, 60/23 and 267/25. There is no separate 'Law on Medical Devices'.

Macedonian. This contradicts the common assumption that a candidate country runs a standalone device statute: the device rules are a chapter (IV. МЕДИЦИНСКИ СРЕДСТВА) of the medicines act. MALMED's own statutory index (res-mk-malmed-laws-index) reproduces the same chain and shows the renaming, which is what makes the title switch visible.

The 88/15 amendment renamed the act from medical aids to medical devices

legal-basis.statute-renaming-2015

Fact-level verified

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 лековите и медицинските средства) by the amending act in Сл. весник на РМ 88/15, whose own title still carries the old name but whose Член 69 authorises a consolidated text of the 'Закон за лековите и медицинските средства'. From 154/15 onward every amending act is titled with 'медицинските средства'. Older sub-legal instruments adopted under the former name (including the still-operative device registration rulebook Сл. весник на РМ 151/10) still use the term 'медицински помагала' for the same subject matter.

Macedonian. The index lists 'Закон за изменување и дополнување на Законот за лековите и медицинските помагала (Сл. весник на РМ, бр. 88/15)' immediately followed by 'Закон за изменување и дополнување на Законот за лековите и медицинските средства (Сл. весник на РМ, бр. 154/15)'. A filer searching only for 'Закон за медицински средства' will not find the statute, and sub-legal acts predating 2015 must be read with 'помагала' = 'средства'.

Manufacturer PMS

Which PMS plan, report, PMCF or PMPF, trend, and lifecycle-update duties apply?

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A device marketing-authorisation holder must organise a materiovigilance system run by an employed responsible person from the health field

pms.materiovigilance-system-and-responsible-person

Fact-level verified

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 who has a health-field qualification. The materiovigilance system covers the collection, processing and assessment of periodic safety reports for medical devices received from the marketing-authorisation holder and the data from post-market non-interventional studies.

Conditions

The materiovigilance obligations apply to devices as they apply to medicines, by the cross-reference in Article 138 of the Law.
Post-market non-interventional study data feed into the same assessment duty under Article 12(3).
The rulebook fixes a Data lock point (DLP) as the reference date for the periodic reports (Article 2(12)).

Macedonian. Правилникот за материовигиланца (Сл. весник на РМ 100/16) Article 14 requires the marketing-authorisation holder to organise the materiovigilance system with an employed responsible person from the health field; Article 12(2) covers processing and assessing periodic device safety reports.

Authorisation holders submit periodic device safety reports referenced to a Data lock point

pms.periodic-safety-reporting-and-dlp

Fact-level verified

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 the materiovigilance system processes and assesses those reports together with the data from post-marketing non-interventional studies received from the holder.

Conditions

The DLP is the reference date for the periodic report; the rulebook defines it but does not fix the reporting interval.
Under Article 12(4)–(5) the materiovigilance system notifies the marketing-authorisation holder and healthcare workers of serious adverse reactions immediately and at the latest within 15 days of receipt of the information; the holder's own reporting deadlines are those of Article 88–89 of the Law applied through Article 138.

Macedonian. Article 2(12) of the 100/16 rulebook defines 'Датум на заклучување на податоците (DLP)'; Article 12(2) and (3) set the processing and assessment duties for periodic safety reports and post-market non-interventional study data.

Official forms & portals

Which current form, portal, account, and submission package must be used?

Compare countries

MALMED publishes the class-specific device registration forms and the parallel-import application form online

forms.device-application-forms-portal

Fact-level verified

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), Образец бр. 4 (active implantable medical devices), the parallel-import application form 'Барање за одобрение за паралелен увоз на медицински средства – образец ПУМПС', and an application form for a wholesale-activity register entry. The devices forms page sits under the Agency's medical-devices section alongside the rulebooks and the guidance pages.

Conditions

The forms are published as .docx (devices) and .doc (parallel import) files; the printed form numbers correspond to Article 2 of the 151/10 rulebook.
The parallel-import form ПУМПС is a separate instrument from the four registration forms and is not among the four enumerated in the 151/10 rulebook.

Macedonian. The page lists the four registration forms, the ПУМПС parallel-import form and the wholesale-activity application form; MALMED is the only publisher of these forms.

QMS, audit & inspection

Which QMS, audit, inspection, and certificate scope is accepted or required?

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An EN ISO 13485 quality-system certificate is a mandatory dossier document for every registered device

qms.en-iso-13485-certificate-required

Fact-level verified

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 device without one. The certificate is required from a manufacturer seated in the European Union and from a manufacturer seated outside it, in the latter case together with the name of the authorised representative in the EU.

Conditions

The rulebook requires the certificate as a document; it does not itself provide for a MALMED audit of the manufacturer's quality system.
Where the device has no EC certificate the full quality, safety and efficacy data under Article 8 are required in addition to the certificate.

Effective from 2010-11-30

Macedonian. Article 7 item 3 of the 151/10 rulebook lists 'сертификат за системот на квалитет EN ISO 13485' in the EC-certificate documentation set; the registration form section III requires the same certificate from the manufacturer regardless of its seat. The rulebook is a 2010 sub-legal act still published by MALMED as the applicable device registration rulebook.

Pharmaceutical inspectors may follow the manufacturer's quality-control system, order conformity assessment, take samples and ban manufacture or placing on the market

qms.inspector-powers-over-devices-and-quality-systems

Fact-level verified

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 authorised body, to take samples and have them tested, to ban or temporarily ban the manufacture, testing or placing on the market of a device, to temporarily ban the work of a legal entity, to seize devices found with an unregistered manufacturer, to ban advertising, to order the destruction of a device, and to ban a clinical investigation.

Conditions

The inspector's measures are enforced through Article 146, which allows a ban of up to six months, orders to align operations, prohibitions, destruction orders, temporary withdrawal and seizure, and import bans.
A second measure under Article 146 is a ground for revoking the entity's licence and erasing it from the register (Article 148).

Macedonian. Article 153 enumerates the inspector's powers over medical devices; the quality-control-system power is the first of them. The supervisory mandate itself is in Article 141.

Recall, FSCA & market surveillance

Which recall, FSCA, notice, and authority-coordination duties apply?

Compare countries

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

recall.administrative-penalties-by-entity-size

Fact-level verified

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 3,000 EUR for a micro entity, 5,000 to 6,000 EUR for a small entity, 15,000 to 18,000 EUR for a medium entity and 25,000 to 30,000 EUR for a large entity. The responsible person in the legal entity is fined 1,200 to 1,500 EUR and the employee 500 to 750 EUR.

Conditions

The device offences are enumerated at items 38 to 52 of Article 154; the labelling/instructions offence is item 46.
Submitting false data, a false statement or false proof in the register-entry or parallel-import procedure is separately a criminal offence carrying six months to five years (Article 156-ѓ).
The amounts are stated in euros and collected in denar counter-value.

Macedonian. Article 154 sets out the device offences at items 38 to 52 and the size-scaled fine ranges. The euro amounts are those printed in the consolidated text.

The inspector may temporarily withdraw or seize a device, order destruction, ban import and ban the entity's work for up to six months

recall.inspector-measures-withdrawal-seizure-and-destruction

Fact-level verified

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 with the Law, a prohibition, an order to destroy the device, temporary withdrawal or seizure of the device, a ban on import, and a temporary ban on the legal entity's work. A second measure under the same article is a ground for revoking the entity's licence and erasing it from the register.

Conditions

A parallel-imported device withdrawn from circulation in the source country must be notified to the Agency within 15 days and the parallel-import approval is then revoked.
The compulsory joint annual control of large wholesalers (turnover above 10,000,000 denars) by two pharmaceutical inspectors, two tax inspectors and one customs officer is part of the same surveillance framework (Article 141(5)).

Macedonian. Article 146 enumerates the inspector's measures including the six-month ban, destruction orders, temporary withdrawal and seizure and the import ban; Article 148 provides for revocation of the licence and erasure from the register on a second measure.

Withdrawal of a device in the source country must be notified within 15 days and false filings are criminal offences

recall.withdrawal-notification-and-criminal-liability

Fact-level verified

The holder of a parallel-import approval must notify the Agency within 15 days where the device is withdrawn from circulation in the source country, and the Agency revokes the approval on that ground. Independently of the administrative penalties, submitting false data, a false statement or false proof in the procedure for entering a device in the register, or in the procedure for obtaining a parallel-import approval, is a criminal offence punishable by six months to five years of imprisonment.

Conditions

The 15-day notification is a duty on the parallel-import holder and is distinct from the 60-day change notification.
The criminal provision reaches the register-entry and parallel-import procedures specifically, not device offences generally.

Macedonian. Article 131-а(9) sets the 15-day withdrawal notification and the revocation consequence; Article 156-ѓ makes a false filing in the register-entry or parallel-import procedure punishable by six months to five years.

Registration pathways

Which registration, notification, listing, reliance, or conformity route applies?

Compare countries

Four class-specific application forms: Образец бр. 1 (class I), бр. 2 (IIa/IIb/III), бр. 3 (IVD), бр. 4 (AIMD)

registration.class-specific-application-forms

Fact-level verified

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 form No. 4 for active implantable medical devices. Applicants may be a manufacturer, a legal representative of a foreign manufacturer under a representation contract, a branch of a foreign manufacturer, or a trade representation of a foreign manufacturer, each with a registered seat in the country and valid insurance covering the territory of the country.

Conditions

All four forms are published by MALMED on its device forms page (res-mk-malmed-device-forms) as Обрасци бр. 1–4 plus the parallel-import form 'Барање за одобрение за паралелен увоз на медицински средства – образец ПУМПС'.
The rulebook was adopted under the pre-2015 name of the statute, so it speaks of 'медицински помагала'; the subject matter is today's medical devices.

Effective from 2010-11-30

Macedonian. The rulebook is Правилник … за запишување на медицинските помагала во регистерот на медицински помагала, Сл. весник на РМ бр. 151 од 22.11.2010, adopted by the Minister of Health under Article 131(3) of the Law; Article 24 gives entry into force on the eighth day after publication, i.e. 30 November 2010. MALMED still publishes it as the operative device registration rulebook.

Separate registers for manufacturers and for wholesale/retail legal entities, each with its own entry conditions

registration.manufacturer-and-wholesaler-registers

Fact-level verified

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 medical devices may be performed only by legal entities entered in the register of legal entities for wholesale of medical devices; specialised shops performing retail of medical devices must be entered in the register of specialised shops for medical devices. Manufacturer entry requires data on premises, equipment, staff and the quality system, the address and Central Register certificate, a list of devices manufactured with their classification, data on design, quality control and maintenance, and proof of liability insurance.

Conditions

MALMED publishes the resulting register of domestic manufacturers on its site (res-mk-malmed-device-manufacturers), currently listing producers of gauze and bandages, haemodialysis solutions, X-ray film, clinical-biochemical reagents, ultrasound gel, adult nappies, blood-line components, non-sterile bandages, single-use class I masks and orthopaedic aids.

Macedonian. Entry conditions and the fees payable, and the form and content of the entry form for manufacturers, are prescribed by the Director of the Agency (Article 123 final paragraph); the manufacturer-premises rulebook listed by MALMED is Правилник за поблиските услови … што треба да ги исполнат производителите на медицински помагала, Сл. весник на РМ бр. 19/09.

A national register of medical devices placed on the market, with an entry decision issued by MALMED

registration.national-device-register-and-marketing-approval

Fact-level verified

MALMED keeps a register of manufacturers, a register of legal entities performing wholesale and retail circulation of medical devices, and a register of medical devices available on the market in the country. The content of the application form and the documentation for entry of a device in the register of medical devices are prescribed by the Director of the Agency. Entry is a national act: MALMED's register page states that the Agency keeps the register of medical devices on the territory of the country for which the appropriate approval for placing on the market has been issued, and the Law's penalty and parallel-import provisions refer to the register entry number and to 'the procedure for entry of a medical device in the register of medical devices'.

Conditions

A CE-marked device does not enter the market on the strength of CE marking alone: the national register entry must still be obtained.
MALMED's register page (res-mk-malmed-device-register) states the register covers devices 'за кои е издадено соодветно одобрение за ставање во промет во Република Македонија' (for which the appropriate approval for placing on the market has been issued).
The register is queried through MALMED's integrated information system; the register page links to the register and to the device table.

Macedonian. This is the sharpest operational difference from an EEA state such as Iceland, where there is no national device register at all. Article 131(2) requires the Director to prescribe the register formats and the fees connected with registration, which is the authority for the fee rulebook.

A separate parallel-import approval for devices, available only to a registered wholesaler (or a health institution for its own needs)

registration.parallel-import-approval-pathway

Fact-level verified

A parallel import of medical devices may be performed only by a wholesale undertaking holding a wholesale authorisation issued by a competent authority in the country; a health institution may parallel import exclusively for its own needs. The applicant must hold a valid approval for parallel import of a medical device issued under the Law, and the device must already be entered in the country's register of medical devices and be in circulation there.

Conditions

The application is made on the prescribed parallel-import form (образец ПУМПС) published by MALMED.
Article 131-а(3) lists fifteen documentary items, including data on the device already registered nationally, data on the device to be imported and the source country, differences between the two, an insurance policy valid for the territory, the EC certificate or European EC declaration of conformity, proof that the device is in circulation in the source country, a statement that the importer is not commercially or capital-linked to the holder of the national registration, and a Macedonian-Cyrillic package label.
Health-institution parallel import for own needs is recorded separately under special-access-derogation (Article 131-б).

Macedonian. The reliance content of this route is recorded as its own reliance-recognition fact; this fact records only that the pathway exists as a distinct registration track with its own application form.

Reliance & recognition

Which foreign decisions or evidence can be reused, with what effect and conditions?

Compare countries

Existing records include acceptance, restrictions and evidence reuse. The applicable product scope and conditions are preserved below; a reference does not by itself confer market access.

North Macedonia approvals and evidence in other markets (0 records)

No linked record is currently maintained. This does not establish that a pathway is unavailable.

Prior approvals and evidence for North Macedonia (8 records)

North MacedoniaEU conformity assessment

Prior approval / evidence record

EU CE marking — a certificate of EC conformity issued by a notified body

Authority: EU CE marking — a certificate of EC conformity issued by a notified body
Accepted: Yes
Benefit: A device that holds a certificate of EC conformity follows the abridged documentation route in чл. 7 of the 151/2010 rulebook (declaration of conformity, EC certificate, EN ISO 13485 certificate, free-sale certificate, insurance policy and representation contract) instead of the full quality, safety and efficacy dossier required by чл. 8, and чл. 22 of the same rulebook ties the register entry's validity to the validity of the certificate. It does not remove the national register entry: чл. 131 of the Law still requires the device to be entered in MALMED's register, and чл. 119 ст. 3 governs the EC mark on the device. A declaration under the MDD or AIMD is not converted into a certificate under Regulation (EU) 2017/745 by this route, because North Macedonia is not an EU/EEA member state and does not apply that Regulation.

Закон за лековите и медицинските средства (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 121, 123, 129, 130, 131, 131-а, 132 and 134 Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 days 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, 17 and 22

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

North MacedoniaUS FDA

Prior approval / evidence record

US FDA 510(k) clearance or PMA approval

Authority: US FDA 510(k) clearance or PMA approval
Accepted: No
Benefit: No substitute for the documents MALMED recognises and no reduction in the procedure or the fee. A US clearance is useful only as supporting technical documentation inside the чл. 8 dossier for a device that has no EC certificate.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

North MacedoniaSource authority not specified

Prior approval / evidence record

An origin-country free-sale certificate is a mandatory dossier document on both the EC-certificate and the non-EC route

reliance.origin-country-free-sale-certificate-mandatory

Fact-level verified

Statement: Proof that the device is placed on the market in the manufacturer's own country — a Free sale certificate — is a required document in the device registration dossier, both where the device holds an EC certificate of conformity and where it does not. It is verification paperwork: it does not shorten the national review or substitute for the EC certificate, and on the non-EC route the full quality, safety and efficacy dossier and an Agency efficacy opinion still apply.
Source Approval: Origin-country marketing status evidence — Free sale certificate from the authority of the manufacturer's country (any country)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Dossier Format
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Also required at renewal: Article 20(4) of the same rulebook lists the free-sale certificate among the updated administrative documents for renewal of a registration.
The source country is not restricted to the EU: the rulebook says 'земјата на производителот' (the manufacturer's country).

Effective from 2010-11-30

Macedonian. Article 7 item 4: 'доказ дека медицинското помагало се наоѓа во промет во земјата на производителот (Free sale certificate)'. Article 8 repeats the same item in the administrative-data block for devices without an EC certificate. This is a distinct mechanism from the notified-body route and is filed as its own fact.

North MacedoniaSource authority not specified

Prior approval / evidence record

Origin-country free-sale certificate

Authority: Origin-country free-sale certificate
Accepted: No
Benefit: Not an approval route and not a substitute for the national register entry; it is a mandatory item of the administrative documentation that чл. 8 of the 151/2010 rulebook requires for a device without an EC certificate — "доказ дека медицинското помагало се наоѓа во промет во земјата на производителот (Free sale certificate)". It evidences that the device is marketed in the manufacturer's country and does not shorten the MALMED procedure.

Maintained reference · planning ranges remain estimates · reviewed 2026-09-16

North MacedoniaEU conformity assessment

Prior approval / evidence record

An EU-recognised notified body's EC certificate opens an abridged national dossier route, but the national registration decision is still taken

reliance.eu-notified-body-ec-certificate-abridged-route

Fact-level verified

Statement: North Macedonia recognises conformity assessment performed through institutions recognised in the European Union. A device whose conformity is assessed by a notified body recognised in the European Union is marked with the EC mark, and the Agency accepts the resulting EC certificate or the manufacturer's EC declaration of conformity in place of full quality, safety and efficacy data. Where the device holds an EC certificate the registration dossier is the short documentary set in Article 7 of the 151/10 rulebook; where it does not, Article 8 requires the full administrative dossier plus quality, safety and efficacy data and an Agency opinion on efficacy, with risk analysis for class IIb, III, AIMD and List A/B IVDs. CE marking does not by itself confer market access: the device must still be entered in the national register of medical devices by decision of the Agency.
Source Approval: EU CE marking — EC certificate of conformity issued by a notified body recognised in the European Union, or (for class I devices and general IVDs) the manufacturer's European EC declaration of conformity
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

A local application is always required: the device must be entered in MALMED's register of medical devices and the applicant must be a domestic manufacturer, a legal representative, a branch or a trade representation with a registered seat in the country and insurance covering its territory.
The abridged dossier is documentary only — declaration of conformity, EC certificate (except class I and general IVDs), EN ISO 13485 certificate, free-sale certificate, insurance and representation contract — and the Agency may still require further data.
A nationally authorised conformity-assessment body may be used instead; the Law provides for bodies authorised by the Minister of Health.
The Law's conformity-assessment provisions are based on the pre-MDR MDD/AIMDD/IVDD certificate architecture; MDR (EU) 2017/745 and IVDR (EU) 2017/746 do not apply directly in North Macedonia.

Macedonian. Article 118(1) states the two permitted conformity-assessment routes: 'со оцена на сообразноста преку институции препознаени во Европската унија, односно соодветно тело за оцена на сообразноста или преку тела овластени од страна на министерот за здравство'. Article 119(3): 'медицинско средство, чија сообразност со општите и посебните услови е проценето од тело за оцена на сообразноста, односно од нотифицирано тело препознаено во Европската унија, е означено со ЕC ознака.' marketAccessStrength is 'facilitated' and not 'direct' because the recognised certificate opens a shortened documentary route only; the Agency retains and exercises its own registration decision.

North MacedoniaUS FDA · Japan MHLW / PMDA · South Korea MFDS · NMPA

Prior approval / evidence record

No route exists for non-EU approvals (FDA, PMDA, MFDS, NMPA and similar)

reliance.non-eu-approvals-no-route

Fact-level verified

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 institutions recognised in the European Union or bodies authorised by the Minister of Health, and the device registration rulebook distinguishes only between devices that hold an EC certificate and devices that do not. A US FDA 510(k) clearance or PMA approval, a Japan PMDA approval, a Korea MFDS approval or a China NMPA registration can be placed in the technical documentation as supporting material but substitutes for nothing: without the EC certificate or EC declaration of conformity the full quality, safety and efficacy dossier under Article 8 of the 151/10 rulebook applies, together with an Agency opinion on efficacy.
Source Approval: none
Edge Type: No Reliance Route
Market Access Strength: none
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The negative is drawn from an exhaustive enumeration: Article 118(1) names two and only two conformity-assessment routes, and Article 119(3) names the EC mark as the marking that follows from a recognised notified body. No non-EU regulator is named anywhere in the Law's device chapter.
The counter-check is Article 8 of the 151/10 rulebook, which applies the full dossier when the device does not hold an EC certificate — the rulebook contemplates no third category based on a non-EU approval.
A device manufactured outside the EU is not shut out entirely: it reaches the market either through a notified body recognised in the EU, through a body authorised by the Minister of Health, or on the non-EC full dossier route.

Verified negative. Macedonian. Article 118(1) is exhaustive in form ('Постапката за оцена на сообразноста на медицинските средства се врши: … или …'). The same conclusion is reached on the origin-country side: the free-sale certificate is required from the manufacturer's own country whatever that country is, which shows the Law is not operating a reference-country recognition list. FDA, PMDA, MFDS and NMPA were searched for in the consolidated Law and in the device rulebooks and appear nowhere.

North MacedoniaSource authority not specified

Prior approval / evidence record

Memoranda of cooperation with foreign agencies (ALIMS, BDA, CALIMS, ALMBiH, HALMED, MHRA) create no market-access route

reliance.regulator-cooperation-memoranda-create-no-route

Fact-level verified

Statement: MALMED has signed memoranda of cooperation with the medicines agencies of Serbia (ALIMS), Bulgaria (BDA), Montenegro (CALIMS), Bosnia and Herzegovina (ALMBiH), Croatia (HALMED) and England (MHRA). The stated scope of these memoranda is the advancement of staff expertise, the exchange of information and experience, and the monitoring of health policies and European legislation. They create no abridged review, no acceptance of a foreign registration, and no market-access route; a device approved only by one of these agencies still requires the full national registration with MALMED.
Source Approval: Serbia ALIMS, Bulgaria BDA, Montenegro CALIMS, Bosnia and Herzegovina ALMBiH, Croatia HALMED, England MHRA — memoranda of cooperation
Edge Type: Cooperation Mou
Market Access Strength: none
Regulatory Layer: institutional
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Recorded as a cooperation mechanism that creates no route, not as recognition: the memoranda are expressly limited to staff development, information exchange and policy monitoring.
The page also records participation in the EMA IPA programme, a representative on the EDQM expert committees, WHO partnership, support for the Council of Europe MEDICRIME Convention and TAIEX cooperation — none of which confers device market access.

Macedonian. The page states: 'Согласно овие меморандуми предвидена е соработка во делот на унапредување на стручниот потенцијал на вработените, размена на информации и искуства, следење на здравствените политики и европската легислатива.' No market-access effect is stated. Note that Croatia (HALMED) and Bulgaria (BDA) are EU member states, but the memoranda do not convert their approvals into a North Macedonian route — the EU route runs through the notified-body/EC-certificate mechanism recorded above, not through these memoranda.

North MacedoniaSource authority not specified

Prior approval / evidence record

Parallel import of an already nationally registered device recognises the source country's authorisation and market presence

reliance.parallel-import-source-country-authorisation

Fact-level verified

Statement: North Macedonia operates a unilateral parallel-import approval for medical devices. A registered wholesaler may import the identical device that is already entered in the national register and in circulation there from another country, on proof of the authorisation under which the device is entered with the competent authority of the source country, proof that it is in circulation there, a wholesale authorisation of the source supplier, the approved source-country instructions for use, and the EC certificate or European EC declaration of conformity. The device itself is not re-reviewed: what is checked is the source-country authorisation and the differences from the nationally registered version. The Agency grants a temporary approval within eight working days, allowing participation in public procurement, and the full approval within three days of full payment of the fee, valid for two years. If the device is withdrawn from circulation in the source country the Agency revokes the approval.
Source Approval: Marketing authorisation / registration of the identical device by the competent authority of the source (exporting) country, together with the EC certificate of conformity or the manufacturer's European EC declaration of conformity
Edge Type: Unilateral Recognition
Market Access Strength: facilitated
Regulatory Layer: Import Control
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

Only a wholesaler registered in the country may hold the approval; a health institution may parallel import solely for its own needs (Article 131-б).
The device must already be registered in North Macedonia's own register of medical devices — this route does not admit a device that has never been nationally registered.
The temporary approval (eight working days) permits participation in public-procurement procedures and conclusion of supply contracts; the full approval issues within three days of full payment of the fee and is valid two years.
The holder must follow all changes to the device in the source country and notify the Agency within 60 days of the change taking effect there, with proof from the source authority; withdrawal in the source country must be notified within 15 days and causes the Agency to revoke the approval.
The source-country wholesale authorisation and the approved instructions for use must be translated into Macedonian Cyrillic by a court translator, and a supplementary Macedonian-Cyrillic package label is required.

Macedonian. edgeType 'unilateral_recognition' is reused deliberately: it is one of the nineteen tokens the registry already carries, and it describes one state acting alone on another state's authorisation without reciprocity. No other existing token fits — 'abridged_or_recognition_route' is used above for the notified-body dossier route, 'origin_country_evidence' for a purely documentary certificate, and 'import_restriction' describes a bar rather than a route. Article 131-а(3) item 2 requires 'број на одобрение под кое е запишано медицинското средство пред надлежниот орган во земјата од каде што медицинското средство се увезува', item 8 the statement that the device is in circulation in the source country, item 11 the source supplier's wholesale authorisation, and item 7 the EC certificate or European EC declaration of conformity.

Review clocks

What review, validation, and applicant stop-clock rules apply?

Compare countries

A clinical investigation may start if the Agency does not refuse within 30 days — a tacit approval

clocks.clinical-investigation-30-day-tacit-approval

Fact-level verified

Where the Agency does not respond negatively to a clinical-investigation notification within 30 days, the applicant is deemed to be permitted to start the investigation. A change to a clinical investigation is likewise decided within 30 days.

Conditions

The tacit approval is negative-consent only: it applies where the Agency stays silent, and no separate positive decision is issued.
A clinical investigation may be conducted only by a legal entity meeting the premises, equipment, staff and good-practice conditions and authorised by the Director (Article 133).

Macedonian. Article 134(3): 'Ако Агенцијата во рок од 30 дена не одговори негативно на пријавата … се смета дека на подносителот му се дозволува да отпочне со клиничкото испитување.' Article 135(2) sets the same 30-day period for changes.

A parallel-import approval issues within 8 working days in temporary form and within 3 days in full form after payment, valid two years

clocks.parallel-import-8-working-days-and-3-days

Fact-level verified

On a parallel-import application the Agency issues a temporary approval within eight working days, which allows the holder to take part in public-procurement procedures and to conclude supply contracts for the device. The full approval is issued within three days of full payment of the fee and is valid for two years.

Conditions

The eight-working-day temporary approval is expressly linked to public procurement and to the conclusion of supply contracts, not to general marketing.
The three-day period for the full approval runs from full payment of the fee, so the payment step is on the critical path.
The two-year validity is the approval's own term and is separate from the registration validity periods under the 151/10 rulebook.

Macedonian. Article 131-а(5) and (6) set the two periods and the two-year validity. These are working days for the temporary approval; the three-day period for the full approval is stated without qualifier.

MALMED notifies a register entry decision within 90 days, with the clock suspended while additional documentation is requested

clocks.register-entry-notification-90-days

Fact-level verified

The Agency decides on entry into the register of manufacturers, of wholesale traders and of specialised retail shops and notifies the applicant within 90 days. The period is suspended from the day the Agency requests additional documentation from the applicant until that documentation is supplied, so the clock is not a pure statutory deadline.

Conditions

No equivalent statutory decision clock was found for entry of a device itself in the register of medical devices (recorded in unresolved).
The 90-day figure applies to the register entries of economic operators, and to each of the three registers the Article names.

Macedonian. Articles 123(2) (manufacturer), 129(1) (wholesale) and 130(6) (specialised retail shop) each set the 90-day notification with the same suspension rule. The device registration procedure in Article 131 does not carry an equivalent period.

Special access & derogation

Is an emergency, compassionate, custom, humanitarian, or other exceptional path available?

Compare countries

A healthcare institution may parallel-import medical devices exclusively for its own needs and may not place them on the market

derogation.health-institution-parallel-import-for-own-needs

Fact-level verified

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 consent of the Ministry of Health, transfer them to another public healthcare institution at the same price. A breach of this restriction is a criminal offence punishable by six months to five years of imprisonment.

Conditions

The derogation is limited to the institution's own needs; putting the device into circulation is prohibited.
Transfer to another public healthcare institution requires the prior consent of the Ministry of Health and must be at the same price.
The route is a parallel import, so the device must already be registered in North Macedonia and in circulation in the source country.

Macedonian. Article 131-б creates the healthcare-institution parallel-import derogation with the Ministry of Health consent condition for transfers; Article 156-в makes breach of it a criminal offence carrying six months to five years.

Standards, testing & ancillary approvals

Which standards, tests, and radio, electrical, metrology, or other overlays are triggered?

Compare countries

A device is deemed safe if manufactured according to the national standards published in the List of Standards for Medical Devices

standards.national-list-of-device-standards-confers-safety-presumption

Fact-level verified

Medical devices are deemed safe if they are manufactured in accordance with the national standards published in the List of Standards for Medical Devices. The Director of the Agency publishes that List in the Official Gazette of the Republic of Macedonia, which makes the standards list an instrument of the Agency rather than a fixed annex to the Law.

Conditions

The List is published by decision of the Director in the Official Gazette; it is therefore a moving instrument and the standards in force at the date of assessment govern.
Conformity assessment itself runs through a body recognised in the EU or a body authorised by the Minister of Health (Article 118); the standards list supplies the presumption of safety, not the assessment route.

Macedonian. Article 116: 'Медицинските средства ќе се сметаат за безбедни ако се изработени согласно со националните стандарди и објавени во Листата на стандардите за медицински средства.' and 'Директорот на Агенцијата ја објавува Листата на стандарди за медицински средства во „Службен весник на Република Македонија".' The consolidated Law carries the provision; the List itself was not retrieved (recorded in unresolved).

Submission communications & appeal

How are deficiencies answered, clocks handled, and decisions escalated or appealed?

Compare countries

Filings are made in writing in one copy, and photocopies are accepted with a written statement that they match the originals

submission.written-form-copies-and-veracity-statement

Fact-level verified

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 match the originals. The application and its annexes are filed with MALMED on the prescribed form.

Conditions

The written-veracity statement is the mechanism that makes photocopies admissible; an uncertified copy alone does not satisfy the rulebook.
A false statement in the procedure is separately punishable under Article 156-ѓ of the Law.

Effective from 2010-11-30

Macedonian. Articles 11 and 21 of the 151/10 rulebook govern the written form of the filing and the admissibility of photocopies with a written confirmation of veracity. The rulebook is a 2010 sub-legal act still published by MALMED as the applicable device registration rulebook.

UDI, listing & traceability

Which UDI, device listing, database, and traceability duties apply?

Compare countries

Traceability rests on the label identification code, the register device list and wholesale receipt/storage/dispatch records — no UDI-DI or EUDAMED duty

traceability.label-identification-code-and-wholesale-records

Fact-level verified

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)), the list of devices with their classification recorded at wholesale register entry (Article 128), and, for a parallel-imported device, the identification cipher given as an EAN or BAR code (Article 131-а(3)). No obligation to assign a UDI-DI, to upload to EUDAMED or to maintain a UDI database was found in the Law or in the device rulebooks.

Conditions

The negative on UDI is recorded in unresolved: the Law's device chapter and the device rulebooks reviewed contain no UDI/EUDAMED obligation, which is consistent with North Macedonia not being an EU member state and MDR (EU) 2017/745 not applying directly.
The identification code is a label element reviewed at registration; the EAN/BAR form is specified only for parallel imports.

Macedonian. Article 132(2) requires 'код за идентификација' among the label elements; Article 128 requires the register to record the list of devices and their classification; Article 131-а item 1 requires for a parallel import 'шифра за идентификација - ЕАН код, односно БАР код'. A search of the consolidated Law and of the 151/10 and 100/16 rulebooks found no UDI-DI, no UDI database and no EUDAMED duty.

Vigilance & incident reporting

What is reportable, by whom, where, in what format, and by what deadline?

Compare countries

Serious unexpected clinical-investigation reactions with death or life-threatening outcome are reported within 24 hours with a full report in 7 days

vigilance.clinical-investigation-adverse-reaction-reporting

Fact-level verified

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 the full report filed within seven days; a serious non-fatal reaction is reported within 15 days.

Conditions

These periods are specific to clinical-investigation reactions and sit alongside, not instead of, the Article 138 materiovigilance periods for devices on the market.
Healthcare institutions and healthcare workers must report reactions for new devices — those on the market for less than five years — even when the reaction is not serious (Article 8).

Macedonian. Article 4 of the 100/16 materiovigilance rulebook sets the 24-hour initial and 7-day full report for fatal or life-threatening serious unexpected reactions and 15 days for serious non-fatal reactions; Article 8 extends reporting to non-serious reactions for devices on the market less than five years.

MALMED exchanges materiovigilance information with competent authorities in other countries

vigilance.cross-border-information-exchange-with-other-authorities

Fact-level verified

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 information about devices on its market.

Conditions

The exchange duty is an authority-to-authority channel; the reporting duties on manufacturers and healthcare workers run in parallel through the same rulebook.

Macedonian. Article 12(8) of the 100/16 rulebook provides for the exchange of materiovigilance information with competent authorities in other countries. This does not create a market-access route — it is post-market cooperation only.

Materiovigilance applies the pharmacovigilance provisions: 30 days non-serious, 15 days serious and 24 hours for a serious reaction with fatal outcome

vigilance.materiovigilance-applies-pharmacovigilance-deadlines

Fact-level verified

The Law provides that the pharmacovigilance provisions of Articles 87 to 89 apply correspondingly to medical devices as materiovigilance. By that cross-reference the reporting deadlines for device incidents are 30 days for a non-serious adverse reaction, 15 days for a serious adverse reaction, and 24 hours where the serious adverse reaction has a fatal outcome.

Conditions

The deadlines reach devices only through the Article 138 cross-reference, so they are the pharmacovigilance periods of Article 88–89 applied as materiovigilance.
Rulebook 100/16, Article 12(4)–(5), obliges the materiovigilance system to notify the marketing-authorisation holder and healthcare workers of serious adverse reactions immediately and at the latest within 15 days of receipt of the information.
Healthcare institutions and workers report adverse reactions on the form annexed to rulebook 100/16 (Articles 8–10); the rulebook fixes no separate deadline for them.

Macedonian. Article 138: 'Одредбите од членовите 87 до 89 на овој закон кои се однесуваат на фармаковигиланцата, соодветно се применуваат и за медицинските средства како материовигиланца.' The three periods are those of Article 88, applied to devices by that cross-reference.

Related structured datasets

Classification systems · 2 records

Open In vitro diagnostic categories of the Law on Medicines and Medical Devices →

north-macedonia:ivd

Jurisdiction Id

north-macedonia

Domains

Name

In vitro diagnostic categories of the Law on Medicines and Medical Devices

Description

In vitro diagnostic medical devices are classified on their own axis in the Закон за лековите и медицинските средства, separate from the class I / II-а / II-б / III device ladder. Чл. 113 reads: "Медицински средства за ин витро дијагностика се класифицираат како: средства за ин витро дијагностика што се користат исклучиво од страна на стручни лица и класифицирани во зависност од типот на средството во листите А и Б; средства за ин витро дијагностика за само-дијагностицирање и сите други средства за ин витро дијагностика." That is four categories — professional-use devices on List А, professional-use devices on List Б, self-diagnosis devices and all other in vitro diagnostic devices — and the registry's normalization maps the residual category "all others" to low, self-diagnosis to medium, List Б to high and List А to highest, following the list convention the Law inherits from Directive 98/79/EC, in which List А carries the highest-risk assays. The fee schedule in чл. 11 of the Правилник за надоместоци is drafted on the same four categories and prices each of them separately.

Classes

Id
other
Label
Other in vitro diagnostic devices
Normalized Risk Level
low
Id
self-testing
Label
In vitro diagnostic devices for self-diagnosis
Normalized Risk Level
medium
Id
list-b
Label
List Б
Normalized Risk Level
high
Id
list-a
Label
List А
Normalized Risk Level
highest

Regulator

Агенција за лекови и медицински средства (MALMED)

Official Domains

malmed.gov.mk

Source Status

official-source-verified

Reference Sources

Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, нов чл. 11 точка 2
Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Reviewed On
2026-09-16
Supports
The restated чл. 11 point 2 prices the register entry on exactly the four чл. 113 categories — листа А, листа Б, само-дијагностицирање and сите други средства за ин витро дијагностика — which confirms that these four are the operative national groupings for in vitro diagnostic devices.
Title
Правилник за содржината на образецот на барањето … за запишување на медицинските помагала во регистерот на медицински помагала, Сл. весник на РМ бр. 151 од 22.11.2010, чл. 8 and чл. 22
Url
https://malmed.gov.mk/wp-content/uploads/4-Pravilnik-za-obrazec-za-zapisuvanje-na-med.-pomagala-Sl.Vesnik-br.151_od_2010.pdf
Reviewed On
2026-09-16
Supports
Чл. 8 requires risk analysis for List А and List Б in vitro diagnostic devices and чл. 22 gives List Б a two-year and List А a one-year register-entry validity, so the two lists are treated as the higher-risk end of the IVD axis in the dossier and in the validity rule.

Source Title

Закон за лековите и медицинските средства – неофицијален пречистен текст (consolidated unofficial text of the Law on Medicines and Medical Devices, Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 113

Source Url

https://malmed.gov.mk/wp-content/uploads/%d0%97%d0%b0-%d0%b2%d0%b5%d0%b1-%d1%81%d1%82%d1%80%d0%b0%d0%bd%d0%b8%d1%86%d0%b0-%d0%97%d0%b0%d0%ba%d0%be%d0%bd-%d0%b7%d0%b0-%d0%bb%d0%b5%d0%ba%d0%be%d0%b2%d0%b8%d1%82%d0%b5-%d0%b8-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d1%82%d0%b5-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0-%d0%bd%d0%b5%d0%be%d1%84%d0%b8%d1%86%d0%b8%d1%98%d0%b0%d0%bb%d0%b5%d0%bd-%d0%bf%d1%80%d0%b5%d1%87%d0%b8%d1%81%d1%82%d0%b5%d0%bd-%d1%82%d0%b5%d0%ba%d1%81%d1%82-2.docx

Verified On

2026-09-16

Source Supports

ivd-class-axis
ivd-classification-rules

Open Risk classes of the Law on Medicines and Medical Devices →

north-macedonia:medical-device

Jurisdiction Id

north-macedonia

Domains

medical-device

Name

Risk classes of the Law on Medicines and Medical Devices

Description

The national class axis of the Закон за лековите и медицинските средства, not a projection of the EU MDR and not a transposition of it. Чл. 110 grades medical devices by their potential risk to users and reads: "Медицинските средства, во однос на потенцијалниот ризик кон корисниците, се класифицираат како: класа I - медицински средства со низок потенцијал на ризик; класа II-а - медицински средства со висок потенцијал на ризик; класа II-б - медицински средства со повисок потенцијал на ризик и класа III - медицински средства со највисок потенцијал на ризик." The four classes are therefore four distinct risk grades on one ascending ladder of risk potential, and the registry's positional normalization maps class I to low, class II-а to medium, class II-б to high and class III to highest. The same four grades appear a second time on MALMED's own submission surface: the registration forms are split into Образец бр. 1 for class I and Образец бр. 2 for classes II-а, II-б and III, and the 151/2010 registration rulebook keys the register-entry validity to the same four classes in чл. 22.

Classes

Id
i
Label
Class I
Normalized Risk Level
low
Id
iia
Label
Class II-а
Normalized Risk Level
medium
Id
iib
Label
Class II-б
Normalized Risk Level
high
Id
iii
Label
Class III
Normalized Risk Level
highest

Regulator

Агенција за лекови и медицински средства (MALMED)

Official Domains

malmed.gov.mk

Source Status

official-source-verified

Reference Sources

Title
Обрасци за медицински средства (MALMED official form index: Образец бр. 1 class I, Образец бр. 2 classes II-а/II-б/III, Образец бр. 3 in vitro diagnostic devices, Образец бр. 4 active implantable devices, and the parallel-import form ПУМПС)
Url
https://malmed.gov.mk/%d0%be%d0%b1%d1%80%d0%b0%d1%81%d1%86%d0%b8-%d0%b7%d0%b0-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0/
Reviewed On
2026-09-16
Supports
The Agency's own form index is split by risk class — one form for class I, one for classes II-а, II-б and III, one for in vitro diagnostic devices and one for active implantable devices — so the four-class ladder is the class axis the applicant actually submits on, not a label that exists only in the Law.
Title
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. 22
Url
https://malmed.gov.mk/wp-content/uploads/4-Pravilnik-za-obrazec-za-zapisuvanje-na-med.-pomagala-Sl.Vesnik-br.151_od_2010.pdf
Reviewed On
2026-09-16
Supports
Чл. 22 keys the validity of the register entry to the same four classes, giving three years for classes I and II-а, two years for class II-б and one year for class III (and for active implantable devices), which confirms that the four grades are the operative national ladder rather than a drafting artefact.
Title
Информации за медицински средства (MALMED guidance page carrying the device, in vitro diagnostic, class and dispensing definitions)
Url
https://malmed.gov.mk/%d0%b8%d0%bd%d1%84%d0%be%d1%80%d0%bc%d0%b0%d1%86%d0%b8%d0%b8-%d0%b7%d0%b0-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0/
Reviewed On
2026-09-16
Supports
The Agency restates the statutory class definitions and the dispensing classes on its own guidance page, so the class vocabulary the register uses is the one the Law fixes.

Source Title

Source Url

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open North Macedonia registration →

Country

North Macedonia

Jurisdiction Id

north-macedonia

Country Code

Flag

🇲🇰

Regulator

Агенција за лекови и медицински средства (MALMED)

Regulator Abbrev

MALMED

Region

europe

Tier

Risk Classification

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.

Classes

Id
registration-class-i
Class Name
Class I — entry in the register of medical devices
Risk Level
low
Pathway
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
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 days
Url
https://dki.gov.mk/wp-content/uploads/2018/02/%D0%97%D0%B0%D0%BA%D0%BE%D0%BD-%D0%B7%D0%B0-%D0%BE%D0%BF%D1%88%D1%82%D0%B0-%D1%83%D0%BF%D1%80%D0%B0%D0%B2%d0%bd%d0%b0-%d0%bf%d0%be%d1%81%d1%82%d0%b0%d0%bf%d0%ba%d0%b0.pdf
Effective Date
2015-07-31
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Notes
Чл. 131 of the Law on Medicines and Medical Devices requires the device to be entered in the register but fixes no period within which MALMED must decide the application, and no such period was found in the Law or in the 151/2010 rulebook. The clock is therefore the general administrative-procedure period.
Чл. 93 ст. 1 of the Закон за општата управна постапка provides that a first-instance procedure initiated by a party's request is completed in the shortest possible time and at the latest within 30 days of its initiation, "освен кога е поинаку предвидено со закон" (unless a law provides otherwise). Because the device law provides no other period, this residual 30-day period is the period that applies to a чл. 131 application.
Чл. 93 ст. 2 starts the period on the day the party files the request with all the evidence it was obliged to submit, so an incomplete file does not start the clock.
Чл. 94 allows the authority to extend the чл. 93 ст. 1 period once, where the complexity of the matter justifies it, for no longer than the period needed and never by more than 30 days, and requires the extension and its reason to be communicated to the party within the original period. The published row is the unextended 30-day period.
The clock is route-wide: it is fixed for the administrative procedure and does not vary by the device's risk class, which is why the row is bound to the route rather than to a class.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
registration-class-iia
Class Name
Class II-а — entry in the register of medical devices
Risk Level
medium
Pathway
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
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 days
Url
https://dki.gov.mk/wp-content/uploads/2018/02/%D0%97%D0%B0%D0%BA%D0%BE%D0%BD-%D0%B7%D0%B0-%D0%BE%D0%BF%D1%88%D1%82%D0%B0-%D1%83%D0%BF%D1%80%D0%B0%D0%B2%d0%bd%d0%b0-%d0%bf%d0%be%d1%81%d1%82%d0%b0%d0%bf%d0%ba%d0%b0.pdf
Effective Date
2015-07-31
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Notes
Same route-wide 30-day residual period as the class I row: чл. 131 fixes no decision period and чл. 93 ст. 1 of the Закон за општата управна постапка supplies the 30-day default.
Class II-а, class II-б and class III are filed on the same form (Образец бр. 2), so the submission route carries no class-specific clock.
North Macedonia is not an EU/EEA member state, so no notified-body conformity-assessment clock under MDR Annexes IX–XI applies to this row; the notified-body certificate, where there is one, is produced before the file reaches MALMED.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
registration-class-iib
Class Name
Class II-б — entry in the register of medical devices
Risk Level
high
Pathway
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
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 days
Url
https://dki.gov.mk/wp-content/uploads/2018/02/%D0%97%D0%B0%D0%BA%D0%BE%D0%BD-%D0%B7%D0%B0-%D0%BE%D0%BF%D1%88%D1%82%D0%B0-%D1%83%D0%BF%D1%80%D0%B0%D0%B2%d0%bd%d0%b0-%d0%bf%d0%be%d1%81%d1%82%d0%b0%d0%bf%d0%ba%d0%b0.pdf
Effective Date
2015-07-31
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Notes
Same route-wide 30-day residual period as the other class rows.
A class II-б device without an EC certificate must file the risk analysis that чл. 8 of the 151/2010 rulebook requires for classes II-б and III, but that is a dossier requirement and not a separate national clock.
The register entry for a class II-б device is valid for two years under чл. 22 of the 151/2010 rulebook, which is published as registrationValidity rather than as a decision clock.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
registration-class-iii
Class Name
Class III — entry in the register of medical devices
Risk Level
highest
Pathway
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
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 days
Url
https://dki.gov.mk/wp-content/uploads/2018/02/%D0%97%D0%B0%D0%BA%D0%BE%D0%BD-%D0%B7%D0%B0-%D0%BE%D0%BF%D1%88%D1%82%D0%B0-%D1%83%D0%BF%D1%80%D0%B0%D0%B2%d0%bd%d0%b0-%d0%bf%d0%be%d1%81%d1%82%d0%b0%d0%bf%d0%ba%d0%b0.pdf
Effective Date
2015-07-31
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Notes
Same route-wide 30-day residual period as the other class rows.
A class III device and an active implantable medical device get a one-year register-entry validity under чл. 22 of the 151/2010 rulebook, the shortest in the schedule.
Чл. 117 of the Law sends classes II-а, II-б and III, and sterile class I devices and class I devices with a measuring function, through a conformity-assessment procedure that ends in an EC certificate of conformity issued by a notified body, and чл. 119 ст. 3 permits the EC mark to be applied. That certificate is a precondition of the file, not a MALMED clock.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
parallel-import-approval
Class Name
Parallel import — approval to place a parallel-imported medical device on the market
Pathway
Application to MALMED on the parallel-import form ПУМПС under чл. 131-а of the Law, filed by a wholesaler holding a wholesale-trade approval; MALMED issues a provisional approval within eight working days of a complete file, and within three days of full payment of the fee issues the approval valid for two years, which supersedes the provisional one
Official Timeline
Min
8
Max
8
Unit
working-days
Verification Status
official-verified
Official Source
Title
Закон за лековите и медицинските средства (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 121, 123, 129, 130, 131, 131-а, 132 and 134
Url
https://malmed.gov.mk/wp-content/uploads/%d0%97%d0%b0-%d0%b2%d0%b5%d0%b1-%d1%81%d1%82%d1%80%d0%b0%d0%bd%d0%b8%d1%86%d0%b0-%d0%97%d0%b0%d0%ba%d0%be%d0%bd-%d0%b7%d0%b0-%d0%bb%d0%b5%d0%ba%d0%be%d0%b2%d0%b8%d1%82%d0%b5-%d0%b8-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d1%82%d0%b5-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0-%d0%bd%d0%b5%d0%be%d1%84%d0%b8%d1%86%d0%b8%d1%98%d0%b0%d0%bb%d0%b5%d0%bd-%d0%bf%d1%80%d0%b5%d1%87%d0%b8%d1%81%d1%82%d0%b5%d0%bd-%d1%82%d0%b5%d0%ba%d1%81%d1%82-2.docx
Effective Date
2007-08-24
Accessed Date
2026-09-16
Realistic Timeline
Min
8
Max
21
Notes
Чл. 131-а ст. 4 of the Law: the Agency issues a provisional parallel-import approval "во рок од осум работни дена од денот на поднесувањето на барањето со целокупната документација и податоци од ставот 3" — within eight working days of the filing of the request with the complete documentation of ст. 3. The unit published here is working days, as the instrument states it.
Чл. 131-а ст. 5 attaches immediate effect to the provisional approval: with it the wholesaler may take part in public-procurement procedures and conclude delivery contracts for medical devices.
Чл. 131-а ст. 6: within three days of the day of full payment of the fee the Agency issues the parallel-import approval, valid for two years, which contains the data of the provisional approval and repeals it. That three-day period is a payment-triggered step inside the same route and is not published as a separate row.
Чл. 131-а ст. 7 gives the holder 60 days to notify a change to the device in the source country, and ст. 8 gives 15 days to notify a withdrawal from the market there; neither is a first-approval clock.
The parallel-import route is available for a device of any risk class, so it spans classes rather than resolving to one; the fee for it is graduated by the number of products rather than by class (чл. 3 ст. 2 of the Правилник за надоместоци).
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
clinical-investigation-approval
Class Name
Clinical investigation — MALMED approval or notification
Pathway
Notification to, or approval by, MALMED of a clinical investigation of a medical device under чл. 133–135 of the Law; the investigation is deemed approved if MALMED does not decide within the statutory period
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
Закон за лековите и медицинските средства (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 121, 123, 129, 130, 131, 131-а, 132 and 134
Url
https://malmed.gov.mk/wp-content/uploads/%d0%97%d0%b0-%d0%b2%d0%b5%d0%b1-%d1%81%d1%82%d1%80%d0%b0%d0%bd%d0%b8%d1%86%d0%b0-%d0%97%d0%b0%d0%ba%d0%be%d0%bd-%d0%b7%d0%b0-%d0%bb%d0%b5%d0%ba%d0%be%d0%b2%d0%b8%d1%82%d0%b5-%d0%b8-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d1%82%d0%b5-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0-%d0%bd%d0%b5%d0%be%d1%84%d0%b8%d1%86%d0%b8%d1%98%d0%b0%d0%bb%d0%b5%d0%bd-%d0%bf%d1%80%d0%b5%d1%87%d0%b8%d1%81%d1%82%d0%b5%d0%bd-%d1%82%d0%b5%d0%ba%d1%81%d1%82-2.docx
Effective Date
2007-08-24
Accessed Date
2026-09-16
Realistic Timeline
Min
30
Max
60
Notes
Чл. 134 ст. 3 of the Law fixes a 30-day period after which, if the Agency has not decided, the clinical investigation is deemed approved — a tacit-approval clock rather than a decision deadline.
Чл. 134 ст. 4 and чл. 135 ст. 2 each fix a further 30-day period for the steps that follow, so the realistic end-to-end span runs to about two months.
The clock is the same for a device of any risk class and is therefore bound to the route rather than to a class.
The fee for a clinical-investigation approval or notification, and for the accompanying Ethics Committee opinion, is 240 euro each under чл. 6 of the Правилник за надоместоци.
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
No
Id
economic-operator-registration
Class Name
Manufacturer, wholesale and specialised-retail registration — decision period
Pathway
Application to MALMED for entry in the register of medical-device manufacturers (чл. 121 and 123), the register of legal persons for wholesale trade in medical devices (чл. 126 and 129) or the register of specialised retail shops (чл. 130)
Official Timeline
Min
90
Max
90
Unit
days
Verification Status
official-verified
Official Source
Title
Закон за лековите и медицинските средства (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 121, 123, 129, 130, 131, 131-а, 132 and 134
Url
https://malmed.gov.mk/wp-content/uploads/%d0%97%d0%b0-%d0%b2%d0%b5%d0%b1-%d1%81%d1%82%d1%80%d0%b0%d0%bd%d0%b8%d1%86%d0%b0-%d0%97%d0%b0%d0%ba%d0%be%d0%bd-%d0%b7%d0%b0-%d0%bb%d0%b5%d0%ba%d0%be%d0%b2%d0%b8%d1%82%d0%b5-%d0%b8-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d1%82%d0%b5-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0-%d0%bd%d0%b5%d0%be%d1%84%d0%b8%d1%86%d0%b8%d1%98%d0%b0%d0%bb%d0%b5%d0%bd-%d0%bf%d1%80%d0%b5%d1%87%d0%b8%d1%81%d1%82%d0%b5%d0%bd-%d1%82%d0%b5%d0%ba%d1%81%d1%82-2.docx
Effective Date
2007-08-24
Accessed Date
2026-09-16
Realistic Timeline
Min
90
Max
120
Notes
Three separate statutory periods of 90 days, each expressed as a duty to inform the applicant of its entry in the register: чл. 123 ст. 2 "Агенцијата во рок од 90 дена го информира производителот за неговото запишување во регистарот на производители", чл. 129 ст. 1 "Агенцијата во рок од 90 дена е должна да го извести правното лице за запишувањето во регистарот на правни лица за промет на големо", and чл. 130 ст. 6 the same wording for the register of specialised retail shops.
Each of the three is qualified the same way: the period stops running on the day the Agency asks the applicant for additional documentation or data it considers necessary, and resumes on the day that request is satisfied (чл. 123 ст. 3, чл. 129 ст. 2 and чл. 130 ст. 7). The published 90 days is therefore the period on a complete file, and a request for further documentation suspends it rather than extending it by a fixed amount.
These are operator registrations, not device approvals: a foreign manufacturer's device still needs its own чл. 131 register entry, and its local representative must itself satisfy the wholesale-trade conditions or be a branch or trade representation of the foreign manufacturer (чл. 8 of the 151/2010 rulebook).
The clock does not vary with the risk class of any device, which is why the row is bound to the route rather than to a class.
The wholesale register entry carries a 471 euro fee and the specialised-retail register entry 160 euro under чл. 8 of the Правилник за надоместоци as amended.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
EU CE marking — a certificate of EC conformity issued by a notified body
Accepted
Yes
Benefit
A device that holds a certificate of EC conformity follows the abridged documentation route in чл. 7 of the 151/2010 rulebook (declaration of conformity, EC certificate, EN ISO 13485 certificate, free-sale certificate, insurance policy and representation contract) instead of the full quality, safety and efficacy dossier required by чл. 8, and чл. 22 of the same rulebook ties the register entry's validity to the validity of the certificate. It does not remove the national register entry: чл. 131 of the Law still requires the device to be entered in MALMED's register, and чл. 119 ст. 3 governs the EC mark on the device. A declaration under the MDD or AIMD is not converted into a certificate under Regulation (EU) 2017/745 by this route, because North Macedonia is not an EU/EEA member state and does not apply that Regulation.
Authority
Origin-country free-sale certificate
Accepted
No
Benefit
Not an approval route and not a substitute for the national register entry; it is a mandatory item of the administrative documentation that чл. 8 of the 151/2010 rulebook requires for a device without an EC certificate — "доказ дека медицинското помагало се наоѓа во промет во земјата на производителот (Free sale certificate)". It evidences that the device is marketed in the manufacturer's country and does not shorten the MALMED procedure.
Authority
US FDA 510(k) clearance or PMA approval
Accepted
No
Benefit
No substitute for the documents MALMED recognises and no reduction in the procedure or the fee. A US clearance is useful only as supporting technical documentation inside the чл. 8 dossier for a device that has no EC certificate.

Key Requirements

File the application for entry in the register of medical devices with MALMED on the class-specific form — Образец бр. 1 for a class I device, Образец бр. 2 for classes II-а, II-б and III, Образец бр. 3 for an in vitro diagnostic device and Образец бр. 4 for an active implantable device (чл. 131 of the Law; MALMED's form index).
Where the manufacturer has no seat in North Macedonia, appoint a legal representative with a registered seat there, under a representation contract filed with the application; the representative must satisfy the conditions for wholesale trade in medical devices or be a branch or trade representation of the foreign manufacturer (чл. 8 of the 151/2010 rulebook).
File the dossier prescribed by чл. 7 of the 151/2010 rulebook where the device holds an EC certificate of conformity — declaration of conformity, the EC certificate, an EN ISO 13485 certificate, a free-sale certificate, the product-liability insurance policy and the representation contract — or the full administrative, quality, safety and efficacy documentation prescribed by чл. 8 where it does not, including EMC/ES tests and certificates for medical apparatus and clinical data for classes II-а, II-б and III.
Mark the outer and inner packaging, and write the instructions for use, in the Macedonian language and its Cyrillic script (чл. 132 of the Law).
Pay the register-entry fee fixed for the device's class or IVD category in чл. 11 of the Правилник за надоместоци — 300 euro for class I, 400 for class II-а and II-б, 500 for class III, and 300 / 300 / 200 / 400 euro for List А, List Б, self-diagnosis and other in vitro diagnostic devices.
Register with MALMED as a manufacturer, as a wholesale trader or as a specialised retail shop before carrying on that activity, each decided within 90 days (чл. 121 and 123, чл. 126 and 129, чл. 130).
Renew the register entry at the latest 90 days before its validity expires (чл. 17 of the 151/2010 rulebook), and note that the entry's validity is three years for classes I and II-а, two years for class II-б and List Б, and one year for class III, active implantable devices and List А (чл. 22).
For a parallel-imported device, obtain MALMED's parallel-import approval on the form ПУМПС under чл. 131-а, and hold the approval, which is valid for two years, before placing the device on the market.
Carry out materio-vigilance reporting: чл. 138 ст. 1 of the Law applies the pharmacovigilance provisions of чл. 87 to 89 to medical devices as materio-vigilance, and чл. 138 ст. 2 directs the Director of the Agency to prescribe the manner of reporting adverse effects, the types of reaction, how health workers and suppliers act and how the monitoring system is organised. The instrument made under that delegation is the Правилник за начинот за известување на несаканите ефекти за време на користењето на медицинското средство (Сл. весник на РМ бр. 100 од 23.05.2016).
Where the device contains an ionizing-radiation source, hold the DRS licence required by чл. 7 of the Закон за заштита од јонизирачко зрачење и радијациона сигурност before the facility begins work.

Local Rep Required

Yes

Local Rep Name

Правен застапник на странскиот производител со регистрирано седиште во Република Северна Македонија — a legal representative of the foreign manufacturer with a registered seat in North Macedonia, appointed by a representation contract filed with the register application, who must either satisfy the conditions for wholesale trade in medical devices or be a branch or trade representation of the foreign manufacturer (чл. 8 of the 151/2010 rulebook). An importer of a device whose manufacturer is not established in the country assumes the manufacturer's duties under чл. 124 of the Law.

Mdsap Accepted

Mdsap Benefit

North Macedonia does not accept an MDSAP audit report in place of the national documentation. Neither the Law on Medicines and Medical Devices nor the 151/2010 registration rulebook contains an MDSAP provision, and the dossier is built on either the EC-certificate route in чл. 7 or the full documentation route in чл. 8, in which the quality-system evidence is an EN ISO 13485 certificate. No MDSAP-related reliance row exists for this jurisdiction.

Registration Validity

Чл. 22 of the 151/2010 rulebook keys the register entry's validity to the class: for a device holding a certificate of EC conformity the entry is valid for as long as the certificate of conformity is valid; otherwise three years for class I, class II-а and in vitro diagnostic devices including self-testing devices, two years for class II-б and for in vitro diagnostic devices on List Б, and one year for class III, active implantable medical devices and in vitro diagnostic devices on List А. Under чл. 17 the renewal application must reach MALMED at the latest 90 days before the entry's validity expires.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Закон за лековите и медицинските средства (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25), чл. 121, 123, 129, 130, 131, 131-а, 132 and 134
Url
https://malmed.gov.mk/wp-content/uploads/%d0%97%d0%b0-%d0%b2%d0%b5%d0%b1-%d1%81%d1%82%d1%80%d0%b0%d0%bd%d0%b8%d1%86%d0%b0-%d0%97%d0%b0%d0%ba%d0%be%d0%bd-%d0%b7%d0%b0-%d0%bb%d0%b5%d0%ba%d0%be%d0%b2%d0%b8%d1%82%d0%b5-%d0%b8-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d1%82%d0%b5-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0-%d0%bd%d0%b5%d0%be%d1%84%d0%b8%d1%86%d0%b8%d1%98%d0%b0%d0%bb%d0%b5%d0%bd-%d0%bf%d1%80%d0%b5%d1%87%d0%b8%d1%81%d1%82%d0%b5%d0%bd-%d1%82%d0%b5%d0%ba%d1%81%d1%82-2.docx
Effective Date
2007-08-24
Accessed Date
2026-09-16
Title
Закон за општата управна постапка (Сл. весник на РМ бр. 124 од 23.07.2015), чл. 93 ст. 1 and чл. 94 — the residual first-instance decision period of 30 days, extendable once by no more than 30 days
Url
https://dki.gov.mk/wp-content/uploads/2018/02/%D0%97%D0%B0%D0%BA%D0%BE%D0%BD-%D0%B7%D0%B0-%D0%BE%D0%BF%D1%88%D1%82%D0%B0-%D1%83%D0%BF%D1%80%D0%B0%D0%B2%d0%bd%d0%b0-%d0%bf%d0%be%d1%81%d1%82%d0%b0%d0%bf%d0%ba%d0%b0.pdf
Effective Date
2015-07-31
Accessed Date
2026-09-16
Title
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, 17 and 22
Url
https://malmed.gov.mk/wp-content/uploads/4-Pravilnik-za-obrazec-za-zapisuvanje-na-med.-pomagala-Sl.Vesnik-br.151_od_2010.pdf
Effective Date
2010-11-22
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Process

Template Id

default

Status

planning-template

Usage Rule

Maintained planning steps and estimates, not verified regulator deadlines.

Steps

Step
1
Title
Pre-Submission Preparation
Description
Gather technical documentation, quality management system (QMS) records, and clinical data required by MALMED. Appoint a Правен застапник на странскиот производител со регистрирано седиште во Република Северна Македонија — a legal representative of the foreign manufacturer with a registered seat in North Macedonia, appointed by a representation contract filed with the register application, who must either satisfy the conditions for wholesale trade in medical devices or be a branch or trade representation of the foreign manufacturer (чл. 8 of the 151/2010 rulebook). An importer of a device whose manufacturer is not established in the country assumes the manufacturer's duties under чл. 124 of the Law..
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to MALMED including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
MALMED reviews application for completeness. May request additional documents or clarifications.
Duration
2-4 weeks
Icon
🔍
Step
4
Title
Technical Evaluation
Description
In-depth technical assessment of device safety and performance. MALMED may issue questions.
Duration
30 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, MALMED issues North Macedonia market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open North Macedonia fees →

Jurisdiction Id

north-macedonia

Country

North Macedonia

Country Code

Authority

Агенција за лекови и медицински средства (MALMED)

Low Risk Local

Min: 300
Max: 400
Currency: EUR
Per Product: Yes

High Risk Local

Min: 300
Max: 500
Currency: EUR
Per Product: Yes

Details

Id
device-register-class-i
Item
Register entry — medical device of class I
Currency
EUR
Amount Local
300
Amount Local Formatted
EUR 300
Frequency
Per device
Notes
Чл. 11 point 1 of the Правилник за надоместоци as replaced by Сл. весник на РСМ бр. 86 од 28.4.2025: "класа I - 300 евра во денарска противвредност". The amount is fixed in euro and payable in the denar equivalent.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
device-register-class-iia
Item
Register entry — medical device of class II-а
Currency
EUR
Amount Local
400
Amount Local Formatted
EUR 400
Frequency
Per device
Notes
Чл. 11 point 1 as replaced: "класа II-а - 400 евра во денарска противвредност".
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
device-register-class-iib
Item
Register entry — medical device of class II-б
Currency
EUR
Amount Local
400
Amount Local Formatted
EUR 400
Frequency
Per device
Notes
Чл. 11 point 1 as replaced: "класа II-б - 400 евра во денарска противвредност". Class II-а and class II-б are priced identically, so the tariff does not separate the two middle rungs.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
device-register-class-iii
Item
Register entry — medical device of class III
Currency
EUR
Amount Local
500
Amount Local Formatted
EUR 500
Frequency
Per device
Notes
Чл. 11 point 1 as replaced: "класа III - 500 евра во денарска противвредност".
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
ivd-register-list-a
Item
Register entry — in vitro diagnostic device on List А
Currency
EUR
Amount Local
300
Amount Local Formatted
EUR 300
Frequency
Per device
Notes
Чл. 11 point 2 as replaced: "во листа А - 300 евра во денарска противвредност". The IVD column is not ordered by risk: List А and List Б are each 300 euro while "all other" in vitro diagnostic devices are 400.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
ivd-register-list-b
Item
Register entry — in vitro diagnostic device on List Б
Currency
EUR
Amount Local
300
Amount Local Formatted
EUR 300
Frequency
Per device
Notes
Чл. 11 point 2 as replaced: "во листа Б - 300 евра во денарска противвредност".
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
ivd-register-self-diagnosis
Item
Register entry — in vitro diagnostic device for self-diagnosis
Currency
EUR
Amount Local
200
Amount Local Formatted
EUR 200
Frequency
Per device
Notes
Чл. 11 point 2 as replaced: "за само-дијагностицирање – 200 евра во денарска противвредност". This is the lowest device-register line in the schedule.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
ivd-register-other
Item
Register entry — all other in vitro diagnostic devices
Currency
EUR
Amount Local
400
Amount Local Formatted
EUR 400
Frequency
Per device
Notes
Чл. 11 point 2 as replaced: "за сите други средства за ин витро дијагностика - 400 евра во денарска противвредност". The residual IVD category is the most expensive IVD line, which is why the fee bands keyed to risk carry overlapping ranges rather than a monotone one.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
device-register-minor-variation
Item
Minor variation notified to the register of medical devices
Currency
EUR
Amount Local
10
Amount Local Formatted
EUR 10
Frequency
Per variation
Notes
Чл. 11 of the Правилник за надоместоци as replaced by Сл. весник на РСМ бр. 86 од 28.4.2025: a minor variation notified as part of the technological process or of the filed documentation, for which only a notice of record is issued, is 10 euro. A substantive variation is charged at 40% of the register-entry fee for the device's class, which is a formula and is therefore not published as a row here.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Source Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Source Effective Date
2025-05-06
Verified On
2026-09-16
Id
parallel-import-up-to-25-products
Item
Parallel-import approval — medical device, up to 25 products of the same class, list or product group from one manufacturer
Currency
EUR
Amount Local
40
Amount Local Formatted
EUR 40
Frequency
Per product
Notes
Чл. 3 ст. 2 of the Правилник за надоместоци (Сл. весник на РМ бр. 188 од 02.11.2015): the parallel-import charge for a medical device is levied "за секој поединечен производ" and graduated by the number of protected or generic names of the device of the same class, list or product group from one manufacturer; the first band, up to 25 products, is 40 euro per product.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16
Id
parallel-import-up-to-100-products
Item
Parallel-import approval — medical device, up to 100 products
Currency
EUR
Amount Local
24
Amount Local Formatted
EUR 24
Frequency
Per product
Notes
Чл. 3 ст. 2 of the base Правилник: "медицинско средство до 100 производи - 24 евра во денарска противвредност за секој производ одделно".
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16
Id
parallel-import-over-100-products
Item
Parallel-import approval — medical device, over 100 products
Currency
EUR
Amount Local
8
Amount Local Formatted
EUR 8
Frequency
Per product
Notes
Чл. 3 ст. 2 of the base Правилник: "медицинско средства над 100 производи - 8 евра во денарска противвредност" per product.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16
Id
wholesale-register-entry
Item
Entry in the register of legal persons for wholesale trade in medical devices
Currency
EUR
Amount Local
471
Amount Local Formatted
EUR 471
Frequency
Per application
Notes
Чл. 8 ст. 5 of the Правилник за надоместоци, raised from 500 to 471 euro by чл. 1 of Сл. весник на РСМ бр. 110 од 22.5.2026, which replaced the words "500 евра во денарска противвредност" with "471 евра во денарска противвредност" in чл. 8 ст. 1 and ст. 5. Ст. 5 is the medical-device wholesale register; ст. 1 is the medicines wholesale authorisation. The same amendment added чл. 8 ст. 7, a 442 euro charge for a wholesale authorisation for narcotic drugs and psychotropic substances needed for the manufacture of medicines and medical devices.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/Izmenuvanje-i-dopolnuvanje-na-Pravilnikot-za-nadomestoci-br.110-od-2026.pdf
Source Title
Правилник за изменување и дополнување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 110 од 22.5.2026, чл. 1 (чл. 8 ст. 1 and ст. 5: 500 → 471 EUR; new чл. 8 ст. 7); in force the day after publication
Source Effective Date
2026-05-23
Verified On
2026-09-16
Id
specialised-retail-shop-register
Item
Entry in the register of specialised shops for retail trade in certain kinds of medical device
Currency
EUR
Amount Local
160
Amount Local Formatted
EUR 160
Frequency
Per application
Notes
Чл. 8 ст. 6 of the Правилник за надоместоци: "За запишување во регистарот на специјализирани продавници за промет на мало со одредени видови на медицински средства … 160 евра во денарска противвредност". This is the register referred to in чл. 130 of the Law.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16
Id
manufacturing-authorisation-device
Item
Authorisation to manufacture a medical device of a given type and model at a given place of manufacture
Currency
EUR
Amount Local
1000
Amount Local Formatted
EUR 1,000
Frequency
Per type, model and place of manufacture
Notes
Чл. 7 ст. 2 point 1 of the Правилник за надоместоци. Point 2 of the same provision charges 500 euro where only parts of the manufacturing process are carried out at the site.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16
Id
clinical-investigation-approval
Item
Approval or notification for a clinical investigation of a medical device
Currency
EUR
Amount Local
240
Amount Local Formatted
EUR 240
Frequency
Per application
Notes
Чл. 6 ст. 1 of the Правилник за надоместоци: "Во постапката за издавање одобрение или известување за клиничко испитување на медицински средства, надоместоците … изнесуваат 240 евра во денарска противвредност". Ст. 3 of the same article charges 120 euro for an approval of changes to a clinical investigation.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16
Id
clinical-investigation-ethics-opinion
Item
Opinion of the Ethics Committee for a clinical investigation of a medical device
Currency
EUR
Amount Local
240
Amount Local Formatted
EUR 240
Frequency
Per application
Notes
Чл. 6 ст. 2 of the Правилник за надоместоци: the same 240 euro applies to the opinion of the Ethics Committee for clinical and other investigations connected with medicines and medical devices.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16
Id
classification-certificate
Item
Assessment of documentation for a certificate classifying a product as a medicine or a medical device
Currency
EUR
Amount Local
45
Amount Local Formatted
EUR 45
Frequency
Per application
Notes
Чл. 14 ст. 1 of the Правилник за надоместоци: "надоместок за процена на документацијата за издавање потврда за класификација на производите како лекови или медицински средства - 45 евра во денарска противвредност". This is the charge for the Agency's assessment of the documentation for a borderline-classification certificate, which is the determination чл. 115 ст. 1 of the Law makes turn on the main purpose and mode of action defined by the manufacturer.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Source Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Source Effective Date
2015-11-03
Verified On
2026-09-16

Notes

The tariff is set in euro under чл. 11 of the Правилник за надоместоци and is payable in the denar equivalent — the instrument's own words are "во денарска противвредност" on every line — so the published figures are the euro amounts.
The device-register fees currently in force are those of чл. 11 as replaced by Сл. весник на РСМ бр. 86 од 28.4.2025 (in force 6 May 2025); the earlier чл. 11 of the base rulebook (Сл. весник на РМ бр. 188 од 02.11.2015) graded devices on a per-product scale of 40, 24 and 8 euro and no longer applies to a first register entry.
The 2026 amendment (Сл. весник на РСМ бр. 110 од 22.5.2026, in force 23 May 2026) does not touch чл. 11; it amends чл. 8 (wholesale and specialised-retail registers) only.
A substantive variation to a register entry is charged at 40% of the register-entry fee for the device's class rather than at a fixed amount, so the schedule publishes a formula on that line and no exact figure is available for it.
Class II-а and class II-б are charged the same 400 euro, and the in vitro diagnostic column is not ordered by risk (List А and List Б 300 euro, self-diagnosis 200 euro, all others 400 euro), which is why the risk-keyed fee bands overlap.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Правилник за надоместоците и висината на трошоците што се плаќаат во постапките што се водат согласно Законот за лековите и медицинските средства, Сл. весник на РМ бр. 188 од 02.11.2015, чл. 3, 6, 7, 8 and 14
Url
https://malmed.gov.mk/wp-content/uploads/10-Pravilnik_za_nadomestoci_vo_postapkite_soglasno_Zakonot-Sl.Vesnik-br.188-2015.pdf
Effective Date
2015-11-03
Accessed Date
2026-09-16
Title
Правилник за изменување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 86 од 28.4.2025, чл. 2 (replaces чл. 11 — device and in vitro diagnostic register fees); in force the eighth day after publication
Url
https://malmed.gov.mk/wp-content/uploads/86-2025-2.pdf
Effective Date
2025-05-06
Accessed Date
2026-09-16
Title
Правилник за изменување и дополнување на Правилникот за надоместоците … , Сл. весник на РСМ бр. 110 од 22.5.2026, чл. 1 (чл. 8 ст. 1 and ст. 5: 500 → 471 EUR; new чл. 8 ст. 7); in force the day after publication
Url
https://malmed.gov.mk/wp-content/uploads/Izmenuvanje-i-dopolnuvanje-na-Pravilnikot-za-nadomestoci-br.110-od-2026.pdf
Effective Date
2026-05-23
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open North Macedonia certifications →

Slug

north-macedonia

Market

North Macedonia

Confidence

low

Schemes

Id
north-macedonia-medical-electrical-safety
Name
North Macedonian electrical-safety evidence in the device registration dossier
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Electrical safety is not certified by a separate national body in North Macedonia: it is evidence filed with MALMED inside the device registration. Чл. 8 of the Правилник за содржината на образецот на барањето (Сл. весник на РМ бр. 151 од 22.11.2010) sets out the dossier for a device that does not hold an EC certificate of conformity, and among the quality, safety and efficacy data it requires is the item "EMC/ES и други тестови и сертификати за медицинските апарати" — electromagnetic-compatibility and electrical-safety tests and certificates for medical apparatus. A device that does hold an EC certificate takes the abridged route in чл. 7 of the same rulebook, where the electrical-safety evidence sits inside the notified-body certificate and the EN ISO 13485 quality-system certificate rather than being filed separately. Either way the applicant obtains no separate national electrical-safety approval, and there is no national electrical-safety certification mark for a medical device.
Source Urls
https://malmed.gov.mk/wp-content/uploads/4-Pravilnik-za-obrazec-za-zapisuvanje-na-med.-pomagala-Sl.Vesnik-br.151_od_2010.pdf
Source Binding
reviewed
Id
north-macedonia-emc
Name
North Macedonian electromagnetic-compatibility evidence in the device registration dossier
Category
emc
Status
Included In Medical Registration
Object
Finished Device
Note
Electromagnetic compatibility is evidenced to MALMED as part of the registration dossier rather than certified separately. The same чл. 8 item of the 151/2010 registration rulebook — "EMC/ES и други тестови и сертификати за медицинските апарати" — is the operative national requirement, and it is filed only on the non-EC-certificate route, because a device holding an EC certificate of conformity documents its EMC position through that certificate. North Macedonia has no horizontal EMC rulebook of its own that a medical device is separately certified against; the horizontal product-safety regime for electrical equipment sits with the Ministry of Economy and the market inspectorate and is not the route the device takes to the register.
Source Urls
https://malmed.gov.mk/wp-content/uploads/4-Pravilnik-za-obrazec-za-zapisuvanje-na-med.-pomagala-Sl.Vesnik-br.151_od_2010.pdf
Source Binding
reviewed
Id
aek-radio-equipment-market-access
Name
AEK radio-equipment opinion for non-harmonised frequency bands
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Note
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.
Source Urls
https://aek.mk/%D1%80%D0%B0%D0%B4%D0%B8%D0%BE-%D0%BE%D0%BF%D1%80%D0%B5%D0%BC%D0%B0
https://aek.mk/wp-content/uploads/2010/12/k2_attachments_Pravilnik_RTTE.pdf
Source Binding
reviewed
Id
aek-telecom-terminal-equipment
Name
AEK telecommunications terminal equipment conditions
Category
Telecom Network Attachment
Status
Mandatory If Feature
Object
Telecom Terminal Equipment
Note
The same instrument that governs radio equipment — the Правилник за радио опрема и телекомуникациска терминална опрема — governs telecommunications terminal equipment, and AEK's radio-equipment page states that for the use of radio and telecommunications terminal equipment the Agency cooperates with the institutions responsible for the import and use of such equipment, the Ministry of Transport and Communications and the Ministry of Economy. A medical device that is or contains telecommunications terminal equipment intended for connection to a public network is caught by that rulebook as well as by the MALMED registration; a device with no network attachment carries no separate obligation.
Source Urls
https://aek.mk/%D1%80%D0%B0%D0%B4%D0%B8%D0%BE-%D0%BE%D0%BF%D1%80%D0%B5%D0%BC%D0%B0
https://aek.mk/wp-content/uploads/2010/12/k2_attachments_Pravilnik_RTTE.pdf
Source Binding
reviewed
Id
bom-legal-metrology
Name
Bureau of Metrology — verification of measuring instruments
Category
Legal Metrology
Status
Mandatory If Feature
Object
Measuring Instrument
Note
The Биро за метрологија (Bureau of Metrology), an organ within the Ministry of Energy, Mining and Mineral Resources under чл. 4 of the Закон за метрологијата, operates the national legal-metrology system. Чл. 3 makes the protection of human health one of the purposes of the Law and requires traceability to be defined and ensured for all measuring instruments; чл. 21 subjects the measuring instruments covered by the Law to first, periodic and extraordinary verification; чл. 22 places the first verification on the manufacturer and чл. 23 the periodic verification on the holder of the instrument; чл. 26 and чл. 27 empower the minister to prescribe the verification procedure and to determine the categories and types of instrument for which verification is mandatory, together with the periods of periodic verification. A medical device with a measuring function therefore falls under the metrology regime in addition to its MALMED registration, and the Bureau's approved-type and verification regime applies to it.
Source Urls
https://www.bom.gov.mk/wp-content/uploads/2025/02/Zakon-za-metrologija-konsolidiran-tekst.pdf
https://www.bom.gov.mk/zakoni-2
Source Binding
reviewed
Id
drs-ionizing-radiation-licence
Name
DRS licence for activity with ionizing-radiation sources
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Ionizing Radiation Equipment
Note
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.
Source Urls
https://drs.gov.mk/images/pdf/zakoni/zakon-za-zastita-od-joniziracko-zracenje-i-iradijaciona-sigurnost-precisten-tekst.pdf
https://drs.gov.mk/index.php/drs/zakonska-ramka/pravilnici
Source Binding
reviewed
Id
north-macedonia-weee-and-batteries
Name
Extended producer responsibility for waste electrical and electronic equipment and for waste batteries
Category
Environmental And Batteries
Status
Mandatory If Feature
Object
Electrical And Electronic Equipment
Note
The Ministry of Environment and Physical Planning administers the extended-producer-responsibility charges for the special waste streams, and its own waste-charges page names the instruments and the charging articles: the Закон за управување со електрична и електронска опрема и отпад од електрична и електронска опрема (charge under чл. 24 ст. 3 and чл. 36 ст. 5), the Закон за управување со батерии и акумулатори и отпадни батерии и акумулатори (charge under чл. 20 ст. 3 and чл. 35 ст. 7), and the Закон за проширена одговорност на производителот за управување со посебните текови на отпад (Сл. весник на РСМ бр. 215/21) with its financial guarantee under чл. 28 ст. 10 and the non-achievement charge under чл. 32. These bind a producer or importer of a medical device that is electrical or electronic equipment, or that contains batteries, and not the device's market authorisation. The statutes themselves were not retrieved, so the binding is a candidate.
Source Urls
https://www.moepp.gov.mk/mk-MK/uslugi/ziro-smetki-otpad
Source Binding
candidate
Id
malmed-registration-and-parallel-import
Name
MALMED device registration and parallel-import authorisation
Category
Import Conformity
Status
Mandatory At Import
Object
Finished Device
Note
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.
Source Urls
https://malmed.gov.mk/wp-content/uploads/%d0%97%d0%b0-%d0%b2%d0%b5%d0%b1-%d1%81%d1%82%d1%80%d0%b0%d0%bd%d0%b8%d1%86%d0%b0-%d0%97%d0%b0%d0%ba%d0%be%d0%bd-%d0%b7%d0%b0-%d0%bb%d0%b5%d0%ba%d0%be%d0%b2%d0%b8%d1%82%d0%b5-%d0%b8-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d1%82%d0%b5-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0-%d0%bd%d0%b5%d0%be%d1%84%d0%b8%d1%86%d0%b8%d1%98%d0%b0%d0%bb%d0%b5%d0%bd-%d0%bf%d1%80%d0%b5%d1%87%d0%b8%d1%81%d1%82%d0%b5%d0%bd-%d1%82%d0%b5%d0%ba%d1%81%d1%82-2.docx
https://malmed.gov.mk/%d0%be%d0%b1%d1%80%d0%b0%d1%81%d1%86%d0%b8-%d0%b7%d0%b0-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0/
Source Binding
reviewed

Official Sources

Authority
Агенција за лекови и медицински средства (MALMED)
Topic
Закон за лековите и медицинските средства – неофицијален пречистен текст (Сл. весник на РМ 106/07 … Сл. весник на РСМ 267/25)
Url
https://malmed.gov.mk/wp-content/uploads/%d0%97%d0%b0-%d0%b2%d0%b5%d0%b1-%d1%81%d1%82%d1%80%d0%b0%d0%bd%d0%b8%d1%86%d0%b0-%d0%97%d0%b0%d0%ba%d0%be%d0%bd-%d0%b7%d0%b0-%d0%bb%d0%b5%d0%ba%d0%be%d0%b2%d0%b8%d1%82%d0%b5-%d0%b8-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8%d1%82%d0%b5-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0-%d0%bd%d0%b5%d0%be%d1%84%d0%b8%d1%86%d0%b8%d1%98%d0%b0%d0%bb%d0%b5%d0%bd-%d0%bf%d1%80%d0%b5%d1%87%d0%b8%d1%81%d1%82%d0%b5%d0%bd-%d1%82%d0%b5%d0%ba%d1%81%d1%82-2.docx
Authority
Агенција за лекови и медицински средства (MALMED)
Topic
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
Url
https://malmed.gov.mk/wp-content/uploads/4-Pravilnik-za-obrazec-za-zapisuvanje-na-med.-pomagala-Sl.Vesnik-br.151_od_2010.pdf
Authority
Агенција за лекови и медицински средства (MALMED)
Topic
Обрасци за медицински средства — the class-specific registration forms and the parallel-import form ПУМПС
Url
https://malmed.gov.mk/%d0%be%d0%b1%d1%80%d0%b0%d1%81%d1%86%d0%b8-%d0%b7%d0%b0-%d0%bc%d0%b5%d0%b4%d0%b8%d1%86%d0%b8%d0%bd%d1%81%d0%ba%d0%b8-%d1%81%d1%80%d0%b5%d0%b4%d1%81%d1%82%d0%b2%d0%b0/
Authority
Агенција за електронски комуникации (AEK)
Topic
Радио опрема — AEK competence over radio equipment in non-harmonised frequency bands, under чл. 76 ст. 3 of the Закон за електронските комуникации
Url
https://aek.mk/%D1%80%D0%B0%D0%B4%D0%B8%D0%BE-%D0%BE%D0%BF%D1%80%D0%B5%D0%BC%D0%B0
Authority
Агенција за електронски комуникации (AEK)
Topic
Правилник за радио опрема и телекомуникациска терминална опрема
Url
https://aek.mk/wp-content/uploads/2010/12/k2_attachments_Pravilnik_RTTE.pdf
Authority
Биро за метрологија
Topic
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
Url
https://www.bom.gov.mk/wp-content/uploads/2025/02/Zakon-za-metrologija-konsolidiran-tekst.pdf
Authority
Биро за метрологија
Topic
Закони — the Bureau's index of the metrology legislation it administers
Url
https://www.bom.gov.mk/zakoni-2
Authority
Дирекција за радијациона сигурност (DRS)
Topic
Закон за заштита од јонизирачко зрачење и радијациона сигурност (пречистен текст), чл. 1, 7 and 8
Url
https://drs.gov.mk/images/pdf/zakoni/zakon-za-zastita-od-joniziracko-zracenje-i-iradijaciona-sigurnost-precisten-tekst.pdf
Authority
Дирекција за радијациона сигурност (DRS)
Topic
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)
Url
https://drs.gov.mk/index.php/drs/zakonska-ramka/pravilnici
Authority
Министерство за животна средина и просторно планирање (MoEPP)
Topic
Жиро сметки — Отпад: the charging articles of the WEEE, batteries and extended-producer-responsibility statutes
Url
https://www.moepp.gov.mk/mk-MK/uslugi/ziro-smetki-otpad
Authority
Министерство за животна средина и просторно планирање (MoEPP)
Topic
Управување со отпадот — the waste-management regulation index
Url
https://www.moepp.gov.mk/mk-MK/regulativa/upravuvanje-so-otpadot

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Need to apply North Macedonia's requirements to a product?

Confirm the current MALMED pathway, evidence, and local-role details for the actual device before filing.

Pricing

Advertising, claims & promotion

The Law's medicine-advertising rules apply to medical devices, and devices used only in health institutions may not be advertised

Informing the general public about a device requires prior approval from MALMED and must follow the patient leaflet objectively

Approval validity & renewal

Renewal must be applied for at least 90 days before expiry and repeats the documentary set

Registration runs with the EC certificate for EC-certified devices, and otherwise for 3, 2 or 1 years by class

Authority & regime

MALMED is the national medicines-and-devices agency, a self-standing state-administration body with legal personality

Operational name and abbreviation: MALMED / МАЛМЕД, international name 'Macedonian Agency for Medicines and Medical Devices'

MALMED supervises the Law and inspects through pharmaceutical inspectors, with customs officers at import and compulsory joint inspections of large wholesalers

Change control

Changes to a registered device require an amendment application naming one of fourteen enumerated changeable items

Changes to a parallel-imported device must be notified within 60 days of taking effect in the source country

Registered operators must keep their register data current, and the register records the device list and classification

Classification rules

Third axis: transient (<60 minutes), short-term (up to 30 days), long-term (over 30 days)

IVDs: Lists A and B for professional use, self-testing devices, and all others

Second axis: non-invasive, invasive, active

Four risk classes: I, II-a, II-b, III

Clinical investigation & performance

Clinical investigations may be run only by an authorised legal entity, on Helsinki principles, with written revocable informed consent and subject insurance

The sponsor's pre-investigation notification to MALMED carries the device data, safety results, protocol, ethics opinion and consent documents

Device definition & scope

The Law itself defines 'медицинско средство' and the in vitro diagnostic device term in Член 2, точки 49 и 50

Dossier requirements

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

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

The non-EC dossier includes a GMDN or EDMA code; EC-route forms use national category codes

Economic-operator roles

The registration applicant declares itself as manufacturer, authorised representative or representative, and an EU-seated authorised representative is named for non-EU manufacturers

For a foreign-manufactured device the importer into North Macedonia assumes the manufacturer's duties

Wholesale authorisation is a register entry conditioned on premises, staff and an adverse-effect reporting officer

Establishment, import & distribution

Wholesale operators and specialised retail shops need the applicable register entry before starting

Import is controlled by pharmaceutical inspectors together with customs officers at the border

Fees

Device registration fees are charged per class: 300 EUR (class I), 400 EUR (classes IIa/IIb), 500 EUR (class III) and 200-400 EUR for IVDs

Other fixed device charges: 240 EUR clinical investigation, 1,000 EUR manufacturing approval, 1,000 EUR conformity-assessment body authorisation

Parallel-import approvals keep the per-product fee scale: 40 EUR per product up to 25, 24 EUR up to 100, 8 EUR above 100

The wholesale register entry fee is 471 EUR from 23 May 2026, and the specialised retail shop entry is 160 EUR

Label, IFU & language

Devices in circulation must be labelled in Macedonian Cyrillic and carry instructions for use in Macedonian Cyrillic

The mandatory label content is enumerated in the Law and includes an identification code and the standard device marks

Legal basis & guidance

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

The 88/15 amendment renamed the act from medical aids to medical devices

Manufacturer PMS

A device marketing-authorisation holder must organise a materiovigilance system run by an employed responsible person from the health field

Authorisation holders submit periodic device safety reports referenced to a Data lock point

Official forms & portals

MALMED publishes the class-specific device registration forms and the parallel-import application form online

QMS, audit & inspection

An EN ISO 13485 quality-system certificate is a mandatory dossier document for every registered device

Pharmaceutical inspectors may follow the manufacturer's quality-control system, order conformity assessment, take samples and ban manufacture or placing on the market

Recall, FSCA & market surveillance

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

The inspector may temporarily withdraw or seize a device, order destruction, ban import and ban the entity's work for up to six months

Withdrawal of a device in the source country must be notified within 15 days and false filings are criminal offences

Registration pathways

Four class-specific application forms: Образец бр. 1 (class I), бр. 2 (IIa/IIb/III), бр. 3 (IVD), бр. 4 (AIMD)

Separate registers for manufacturers and for wholesale/retail legal entities, each with its own entry conditions

A national register of medical devices placed on the market, with an entry decision issued by MALMED

A separate parallel-import approval for devices, available only to a registered wholesaler (or a health institution for its own needs)

Reliance & recognition

North Macedonia approvals and evidence in other markets (0 records)

Prior approvals and evidence for North Macedonia (8 records)

EU CE marking — a certificate of EC conformity issued by a notified body

US FDA 510(k) clearance or PMA approval

An origin-country free-sale certificate is a mandatory dossier document on both the EC-certificate and the non-EC route

Origin-country free-sale certificate

An EU-recognised notified body's EC certificate opens an abridged national dossier route, but the national registration decision is still taken

No route exists for non-EU approvals (FDA, PMDA, MFDS, NMPA and similar)

Memoranda of cooperation with foreign agencies (ALIMS, BDA, CALIMS, ALMBiH, HALMED, MHRA) create no market-access route

Parallel import of an already nationally registered device recognises the source country's authorisation and market presence

Review clocks

A clinical investigation may start if the Agency does not refuse within 30 days — a tacit approval

A parallel-import approval issues within 8 working days in temporary form and within 3 days in full form after payment, valid two years

MALMED notifies a register entry decision within 90 days, with the clock suspended while additional documentation is requested

Special access & derogation

A healthcare institution may parallel-import medical devices exclusively for its own needs and may not place them on the market