North Macedonia medical device registration timeline
Source-linked clocksАгенција за лекови и медицински средства (MALMED) (MALMED) review clocks and end-to-end planning ranges, using the 4-class (I, II-а, II-б, III) under чл. 110 of the Law on Medicines and Medical Devices, with in vitro diagnostic devices on the separate List А, List Б, self-diagnosis and other axis under чл. 113. This is the country's own national ladder; North Macedonia is an EU candidate country and applies neither Regulation (EU) 2017/745 nor Regulation (EU) 2017/746. classification system.
7 pathways7 of 7 clocks verifiedvalidity 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.MDSAP not acceptedreviewed 2026-09-16malmed.gov.mk
| Class / pathway | Review clock | Planning total | With prior approval | Provenance |
|---|---|---|---|---|
| Class I — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 1, with the documentation prescribed by чл. 7 of the 151/2010 rulebook for devices holding an EC certificate of conformity or by чл. 8 for devices without one) 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. | 30 days | 2-4 months | — | Verified |
| Class II-а — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook) 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. | 30 days | 2-4 months | — | Verified |
| Class II-б — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2 together with the documentation prescribed by чл. 7 or чл. 8 of the 151/2010 rulebook) Same route-wide 30-day residual period as the other class rows. | 30 days | 2-4 months | — | Verified |
| Class III — entry in the register of medical devices(Application to MALMED for entry in the register of medical devices under чл. 131 of the Law, filed on Образец бр. 2, or on Образец бр. 4 for an active implantable medical device) Same route-wide 30-day residual period as the other class rows. | 30 days | 2-4 months | — | Verified |
| Parallel import — approval to place a parallel-imported medical device on the market(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) 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. | 8 working days | 8-21 months | — | Verified |
| Clinical investigation — MALMED approval or notification(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) 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. | 30 days | 2.5-5 years | — | Verified |
| Manufacturer, wholesale and specialised-retail registration — decision period(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)) 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. | 90 days | 7.5-10 years | — | Verified |
Review clocks exclude applicant hold time · planning totals are estimatesPlanning steps and estimates; these are not regulator deadlines.
North Macedonia Medical Device Registration Process
Step-by-step MALMED registration process. Total estimated timeline: 2-4 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather 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..
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to MALMED including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksMALMED reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
30 daysIn-depth technical assessment of device safety and performance. MALMED may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, MALMED issues North Macedonia market authorization certificate.
Summary: The North Macedonia medical device registration process through Агенција за лекови и медицински средства (MALMED) (MALMED) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.
Prior approval recognition
EU CE marking — a certificate of EC conformity issued by a notified bodyA 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.
Origin-country free-sale certificateNot 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.
US FDA 510(k) clearance or PMA approvalNo 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.
Primary regulator sources
malmed.gov.mk · 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 dki.gov.mk · 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 malmed.gov.mk · 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
Reviewed 2026-09-16. End-to-end totals remain planning estimates.
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Source-linked review clocks verified against MALMED publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:north-macedonia:registration-class-i