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ALIMS · Europe

Serbia medical device regulatory resources

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

8 free resources24/25 topics with recordsAug 2026 fees reviewed
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Everything we track for Serbia

Medical device registration database

Search official ALIMS device registration records.

AI medical device classifier

Describe your device and get a preliminary ALIMS risk class with an explanation and source links.

Additional certification and licence checker

Check whether product features may trigger separate radio, electrical, metrology, radiation, import, or other Serbia requirements.

AI similar registered product finder

Describe a device and find comparable products in the ALIMS registration database.

Medical device regulation news

Follow recent ALIMS policy, guidance, safety, and compliance updates.

Government registration fees

Review current ALIMS medical-device fee evidence and price-list availability.

Regulatory requirements data

Browse source-linked lifecycle, language, local-role, renewal, and change-control facts.

Registration timeline

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

Structured regulatory requirements

Explore all 49 source-linked facts →

24 of 25 research dimensions currently covered · 10 official sources · latest verification 2026-09-15

Market entry

D01

Authority & regime

Verified
Competent authority
Agencija za lekove i medicinska sredstva Srbije (ALIMS, Medicines and Medical Devices Agency of Serbia) is the competent authority for medical devices: it performs registration, amendments,…
Ministry of Health role
The Ministry of Health exercises inspection supervision through a medical devices inspector, issues manufacture and wholesale distribution licences, decides classification disputes between…
2 source-linked facts
Checked 2026-08-25
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D02

Legal basis & guidance

Verified
Current primary law and transition
Law on Medical Devices (Zakon o medicinskim sredstvima), "Sl. glasnik RS" No. 105/2017, is the current statute. It entered into force on the eighth day after publication and applies 12 mont…
Registration bylaw
Pravilnik o registraciji medicinskog sredstva (Bylaw on Registration of Medical Devices), "Sl. glasnik RS" 84/2018, 58/2021, 6/2023, prescribes the conditions and manner of recognition of f…
3 source-linked facts
Checked 2026-08-25
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D03

Device definition & scope

Verified
IVD and accessory definitions
An in vitro diagnostic medical device is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system intended for in vitro examinat…
Medical device definition
A general medical device is any instrument, apparatus, appliance, software, implant, reagent, material or other product used alone or in combination, including software provided by the manu…
2 source-linked facts
Checked 2026-08-25
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D05

Registration pathways

Verified
CE mark / foreign certificate route
Devices placed on the market must bear a CE marking or a Serbian conformity mark (Art. 17). Foreign certificates of conformity (certificate, test report, declaration of conformity, certific…
Registration route and Register of Medical Devices
ALIMS registers in the Register of Medical Devices each medical device for which conformity assessment has been carried out and which is placed on the market or into use; the application is…
3 source-linked facts
Checked 2026-08-25
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D06

Reliance & recognition

Verified
China NMPA approval: not reference
statement: Registration with ALIMS under the Pravilnik o registraciji medicinskog sredstva (Sl. glasnik RS 84/2018, 58/2021, 6/2023) requires a Declaration of Conformity and, for all device…
Effect and validity of recognition of foreign documents
An ALIMS decision recognising a foreign document or CE mark is valid until the expiry of the validity term set in the foreign document; if the foreign document sets no expiry term, the reco…
2 source-linked facts
Checked 2026-09-15
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D07

Economic-operator roles

Verified
Authorised representative change
A change of authorised representative is defined by a contract concluded as a rule between the manufacturer, the outgoing and the incoming AR, containing at least: termination date of the o…
Applicant and authorised representative
The registration application is submitted by: (1) the manufacturer (a manufacturer seated in Serbia, or a representative office/branch of a foreign manufacturer seated in Serbia), or (2) th…
4 source-linked facts
Checked 2026-08-25
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D08

Establishment, import & distribution

Verified
Import approval for unregistered devices
ALIMS may exceptionally authorise import of a medical device not registered in Serbia when intended for a particular patient or group of patients, as donation or humanitarian aid or an EU d…
Manufacture licence
The Ministry of Health issues a manufacture licence for Class I devices (other than Is and Im), other IVD medical devices (class A), devices for which no conformity assessment is performed…
3 source-linked facts
Checked 2026-08-25
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D09

Dossier requirements

Verified
Language requirements and comparison documents
For comparison with the manufacturer's original version the applicant also submits: outer/inner packaging proposal in English; for patient self use devices the packaging proposal also in Se…
Registration dossier
Registration dossier (bylaw Art. 10): (1) Declaration of Conformity (original in electronic or paper form, or certified copy); (2) EC Certificate (notified/appointed body certificate), exce…
2 source-linked facts
Checked 2026-08-25
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D10

Official forms & portals

Verified
Registration Form 1 (Obrazac 1)
The registration application is submitted on Obrazac 1 (Form 1), printed as an integral part of the registration bylaw and published by ALIMS in the 6/2023 version; it is completed in the p…
Vigilance electronic reporting portal
Incident reporting by the manufacturer/authorised representative to ALIMS is performed electronically through the Agency portal; if an initial report was given orally (e.g. by phone), a wri…
2 source-linked facts
Checked 2026-08-25
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Submission & evidence

D11

Label, IFU & language

Verified
Electronic IFU
Where a device and accompanying equipment are used exclusively by healthcare professionals, the manufacturer may provide the instructions for use in electronic form instead of paper; before…
IFU in Serbian
Instructions for use accompanying devices on the Serbian market must be written in Serbian and fully comply with the original manufacturer's text; under the labelling bylaw the IFU is in Se…
3 source-linked facts
Checked 2026-08-25
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D12

QMS, audit & inspection

Verified
QMS standard
Quality assurance of each batch of a medical device is performed in accordance with SRPS EN ISO 13485; a manufacturer without a certified quality management system per SRPS EN ISO 13485 per…
Technical documentation retention
The manufacturer must keep the technical documentation and the declaration of conformity after placing the device on the market for at least five years, and for implantable devices at least…
2 source-linked facts
Checked 2026-08-25
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D13

Standards, testing & ancillary approvals

Unresolved
Medical electrical evidence
Electrical safety
RATEL radio equipment conformity assessment
Wireless / radio
Electrical/EMC product conformity
Adapters / components
3 maintained overlays
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D14

Fees

Verified
Registration - Class I, up to 25 products
RSD 13,450
Registration - Class I, 26–100 products
RSD 10,800
13 maintained fee lines · 1 related fact
Checked 2026-08-25
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D15

Review clocks

Verified
Class I · ALIMS registration
30 days
Class IIa · ALIMS registration
30 days
Class IIb · ALIMS registration
30 days
4 maintained pathways · 2 related facts
Checked 2026-08-30
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D16

Approval validity & renewal

Verified
Authorization duration
A registration decision is issued for a validity period ending 60 days after the expiry date of the certificate of conformity. For Class I devices (other than Is and Im classes; bylaw also…
Renewal or maintenance
The manufacturer or authorised representative must file the renewal request at least 30 days before expiry of the registration decision; ALIMS decides within 15 days based on the valid conf…
2 source-linked facts
Checked 2026-08-25
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Lifecycle & post-market

D17

Change control

Verified
Change-control outcomes
A request or notification is required for every amendment of Register data; ALIMS decides within 15 days. Changes that do not affect safety and performance (e.g. graphic design of packaging…
1 source-linked fact
Checked 2026-08-25
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D18

UDI, listing & traceability

Verified
Wholesale traceability records and annual report
Wholesalers must keep records on type, number/quantity of devices sold in Serbia and all imported and exported devices (per pack), containing device name and description, manufacturer and A…
UDI obligations deferred to EU accession
The UDI related provisions of the Law the Unique Device Identification definition (Art. 2 item 98), the importer verification of UDI/bar code (Art. 80(2)(6)), and the UDI/bar code entry in…
2 source-linked facts
Checked 2026-08-25
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D19

Clinical investigation & performance

Verified
Clinical investigation approval requirement
A clinical investigation of a medical device may be conducted only if the benefit exceeds the potential risk to subjects, ALIMS has approved the conduct, and the Ethics Committee of Serbia…
Clinical investigation clocks
ALIMS must approve a clinical investigation within 40 days of receipt; if the application is incomplete ALIMS notifies within 5 days and the applicant completes within 20 days; the 40 day c…
3 source-linked facts
Checked 2026-08-25
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D20

Special access & derogation

Verified
Emergency situation regime
To prevent serious consequences for public health in an epidemic or other emergency, the Government, at the proposal of the Minister, may prescribe a different manner and conditions for pla…
Devices not subject to registration
The following devices are not registered: devices for which a clinical trial approval was issued; devices for continuation of treatment started outside Serbia for the personal use of a spec…
2 source-linked facts
Checked 2026-08-25
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D21

Manufacturer PMS

Verified
Post-market surveillance plan
The manufacturer must establish and maintain a post market surveillance plan involving collection, analysis and investigation of every complaint, quality defect and incident reported by use…
PMS report and PSUR by class
Class I (except Ir, Is, Im) and other IVD/class A manufacturers compile a post market surveillance report (summary of results, conclusions and preventive/corrective measures), updated as ne…
2 source-linked facts
Checked 2026-08-25
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D22

Vigilance & incident reporting

Verified
Reportable incidents
ALIMS records and evaluates incidents defined as: (1) any malfunction or alteration of device characteristics or performance, and irregularities in marking or instructions for use, which le…
Incident reporting deadlines
Manufacturer/AR report to ALIMS, without delay after establishing the device event link: a serious threat to public health at the latest within 2 calendar days of awareness; death or unexpe…
2 source-linked facts
Checked 2026-08-25
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D23

Recall, FSCA & market surveillance

Verified
FSCA notification and urgent withdrawal plan
The manufacturer/AR must notify ALIMS without delay of any initiated Field Safety Corrective Action (FSCA). The manufacturer/AR and the wholesaler must have a plan for urgent withdrawal of…
Withdrawal from market
The Ministry prohibits marketing and orders withdrawal of a device if it is harmful in normal use, fails its performance, has an unfavourable benefit risk ratio, deviates from prescribed co…
2 source-linked facts
Checked 2026-08-25
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D24

Advertising, claims & promotion

Verified
Advertising restrictions
Only a medical device that complies with the essential requirements, or which is registered, may be advertised. Advertising must be truthful, scientifically proven and professional, must no…
1 source-linked fact
Checked 2026-08-25
Open details →
D25

Submission communications & appeal

Verified
Appeal route
An appeal may be filed to the Ministry of Health against ALIMS decisions on registration and its amendments/renewal/removal, clinical trial approvals, pharmacopoeia compliance assessment, r…
1 source-linked fact
Checked 2026-08-25
Open details →

Government fees

Full fee schedule (13 lines) →

ALIMS registration fees in RSD · reviewed 2026-08-25

Fee lineAmountProvenance
Registration - Class I, up to 25 productsRSD 13,450Verified
Registration - Class I, 26–100 productsRSD 10,800Verified
Registration - Class I, over 100 productsRSD 8,100Verified
Registration - Class IIa, up to 25 productsRSD 33,600Verified
9 more fee lines on the full schedule · 13 of 13 rows source-verified

Registration timeline

Full registration timeline →

Medicines and Medical Devices Agency of Serbia (ALIMS) review clocks and planning ranges · 4-class (I, IIa, IIb, III) — EU-aligned (Law on Medical Devices) classification

Class / pathwayReview clockPlanning totalProvenance
Class I(ALIMS registration)30 days2-4 monthsVerified
Class IIa(ALIMS registration)30 days2-4 monthsVerified
Class IIb(ALIMS registration)30 days3-5 monthsVerified
Class III(ALIMS registration)30 days3-6 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(30 days)
  5. 5Registration Approval(1-2 weeks)

Latest regulation news

All Serbia regulation news →

Newest official ALIMS headlines from the daily-refreshed feed — every row links directly to the authority publication.

May 19ALALIMSNotice to Authorized Representatives of Manufacturers in the field of medical devicesSerbia
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Review connected-device architecture, risks, SBOM, testing, lifecycle controls, and market-specific questions for Serbia (ALIMS).

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