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ALMBiH · Europe

Bosnia and Herzegovina medical device regulatory resources

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

5 free resources24/25 topics with records6 regulations trackedSep 2026 fees reviewed
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Additional certification and licence checker

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Government registration fees

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Registration timeline

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

Medical device regulations

Browse Bosnia and Herzegovina's official medical-device instruments — the Law on Medicines and Medical Devices, the Rulebook on Medical Devices, and ALMBiH's registration and EC-certificate recognition guidance — with citeable Bosnian passages.

Changes after registration

Explore questions and sources →

Common questions about changing a registered medical device in Bosnia and Herzegovina. Each question separates published rules from details still awaiting verification.

Structured regulatory requirements

Explore all 54 source-linked facts →

24 of 25 research dimensions currently covered · 23 official sources · latest verification 2026-09-17

Market entry

D01

Authority & regime

Verified
ALMBiH is the state-level competent authority for medical devices
The competent authority for medical devices in Bosnia and Herzegovina is the Agency for Medicines and Medical Devices of Bosnia and Herzegovina (Agencija za lijekove i medicinska sredstva B…
Premises, personnel and retail inspection are Entity and BrÄŤko District competences, not the state agency's
The regime is split. Conditions concerning premises, equipment and personnel for the manufacture and retail of medical devices, and pharmaceutical inspection supervision of retail trade in…
2 source-linked facts
Checked 2026-09-16
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D02

Legal basis & guidance

Verified
Ordinance on Medical Devices (Official Gazette of BiH No. 4/10) made under the Act No. 58/08
The operative instrument for medical devices in Bosnia and Herzegovina is the Ordinance on Medical Devices (Pravilnik o medicinskim sredstvima), Official Gazette of BiH No. 4/10 of 19 Janua…
The Ordinance applies until regulations transposing the relevant EU directives are adopted
The Ordinance on Medical Devices entered into force on the eighth day after its publication in the Official Gazette of BiH and applies until regulations transposing the relevant European Un…
2 source-linked facts
Checked 2026-09-16
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D03

Device definition & scope

Verified
Medical device definition: instruments, apparatus, material and other products; IVDs covered separately
Under the Act, medical devices are instruments, apparatus, material and other products applied to humans which do not achieve their principal intended action by pharmacological, immunologic…
1 source-linked fact
Checked 2026-09-16
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D04

Classification rules

Verified
Bosnian and Herzegovinian classes I, II-a, II-b and III
Class I, Class II-a, Class II-b, Class III
1 maintained scheme · 1 related fact
Checked 2026-09-16
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D05

Registration pathways

Verified
The applicant must be a BiH-based manufacturer or a legal person representing the foreign manufacturer
An application for entry in the Register of medical devices may be submitted only by a manufacturer of medical devices with its seat in Bosnia and Herzegovina, or by a legal person represen…
The Agency issues the registration certificate within 90 days of a complete application
The Agency decides on the entry of a medical device in the Register of medical devices by a certificate of entry, which it is obliged to issue within 90 days of receipt of a complete applic…
4 source-linked facts
Checked 2026-09-16
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D06

Reliance & recognition

Verified
EU-recognised conformity assessment: CE marking is recognised in Bosnia and Herzegovina
statement: Where the conformity of a medical device with the general and special requirements is determined by a conformity assessment body recognised in the European Union, the manufacture…
In vitro diagnostic devices: EC certificate required except List D, with declaration of conformity
statement: For in vitro diagnostic medical devices the registration dossier must contain a certificate of conformity with the directives and regulations of the European Union (CE marking ce…
5 source-linked facts
Checked 2026-09-16
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D07

Economic-operator roles

Verified
Where the device is manufactured abroad the BiH supplier/importer assumes the manufacturer's duties
Where a medical device is manufactured abroad, the duties that the Act places on the manufacturer are assumed in Bosnia and Herzegovina by the supplier or importer of the medical device. Th…
The manufacturer's representative must have its authorisation registered with the Ministry of Foreign Trade
A representative of a medical device manufacturer must hold the manufacturer's authorisation or a representation contract registered with the Ministry of Foreign Trade and Economic Relation…
2 source-linked facts
Checked 2026-09-16
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D08

Establishment, import & distribution

Verified
Retail may only procure from registered wholesalers or registered manufacturers
A legal or natural person engaged in retail of medical devices in specialised medical device shops may procure medical devices only from wholesalers of medical devices, or from a manufactur…
Wholesale distribution requires prior registration of the activity with the Agency
A legal entity engaged in the wholesale distribution of medical devices must, before starting that activity, register its activity with the Agency, which considers the application and keeps…
3 source-linked facts
Checked 2026-09-16
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D09

Dossier requirements

Verified
Insurance policy covering user damage is a mandatory dossier item
The registration dossier must include an insurance policy as proof of insurance of users against damage arising in the application of the medical device. The manufacturer or authorised repr…
ISO 9001:2015 and ISO 13485:2016 certificates required except for Class I devices
The registration dossier must include a quality system certificate (ISO certificate), except for class I medical devices. The Agency's applicant guidance specifies ISO 9001:2015 (quality ma…
3 source-linked facts
Checked 2026-09-16
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D10

Official forms & portals

Verified
Applications must be entered in the Agency's electronic device-sector application
All data, the application, the list of medical devices and the complete documentation submitted to the Agency's registry office must be entered into the electronic application of the Sector…
1 source-linked fact
Checked 2026-09-16
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Submission & evidence

D11

Label, IFU & language

Verified
Registration requires the foreign-language IFU plus a proposed IFU in an official language of BiH
The registration dossier for a class I, IIa, IIb or III device must contain the instructions for use in a foreign language for products of foreign origin together with a proposed instructio…
Instructions for use not required for class I and IIa devices usable safely without them, or for professional use
Instructions for use are exceptionally not required for class I and class IIa medical devices where those devices can be used safely without instructions. Instructions are also not required…
3 source-linked facts
Checked 2026-09-16
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D12

QMS, audit & inspection

Verified
Agency inspectors may inspect the manufacturer's quality system and suspend marketing of non-conforming devices
In carrying out inspection supervision in the field of medical devices, an Agency inspector has the right and the duty to supervise the manufacturer's quality assurance system and, where ne…
1 source-linked fact
Checked 2026-09-16
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D13

Standards, testing & ancillary approvals

Unresolved
BiH technical requirements for products and conformity assessment
Product-specific
ANNT electrical-equipment safety ordinance
Electrical safety
ANNT electromagnetic-compatibility ordinance
EMC
9 maintained overlays · 1 related fact
Checked 2026-09-17
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D14

Fees

Verified
Entry in the Register of medical devices, Class I — up to 25 products by protected or generic name in the application
BAM 200
Entry in the Register of medical devices, Class I — over 100 products by protected or generic name in the application
BAM 100
17 maintained fee lines
Checked 2026-09-16
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D15

Review clocks

Verified
Class I — entry in the ALMBIH Register of medical devices · Application for entry in the Register of medical devices filed with the Agency by a manufacturer seated in BiH or by a legal person representing a foreign manufacturer and seated in BiH, with the manufacturer's own declaration of conformity (Law čl. 101(2)(a))
90 days
Classes II-a, II-b and III — entry in the ALMBIH Register of medical devices · Application for entry in the Register of medical devices after conformity has been determined by an authorised institution, or by the Agency's Commission for Medical Devices where no authorised institution exists (Law čl. 101(2)(b) and the closing paragraph of čl. 101)
90 days
Clinical investigation of a medical device — tacit approval · Notification of a clinical investigation to the Agency by the manufacturer or the importer of the medical device (Law čl. 120(1))
30 days
3 maintained pathways · 1 related fact
Checked 2026-09-17
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D16

Approval validity & renewal

Verified
The holder must renew expired certificates within 30 days or the device is deleted from the Register
The holder of an entry in the Register is obliged to renew, within 30 days, the validity of certificates and other documents that have an expiry date. A manufacturer or representative submi…
Registration certificate is valid for five years
By the Agency's certificate of entry the applicant acquires the right to place the medical device on the market until the expiry of the certificate. The period of validity of the certificat…
2 source-linked facts
Checked 2026-09-16
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Lifecycle & post-market

D17

Change control

Verified
Manufacturer name or address amendments require updated conformity and representation documents
A request to amend the name and/or address of the manufacturer of a medical device must be accompanied, among other items, by an updated letter of authorisation by which the manufacturer au…
The certificate holder must notify the Agency in writing of every change and apply for amendment
During the period of validity of the certificate of entry the holder must inform the Agency in writing of every change, renewal or amendment of the issued certificate or of the submitted do…
2 source-linked facts
Checked 2026-09-16
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D18

UDI, listing & traceability

Verified
Medical device must be entered in the Agency's Register before it may be placed on the market (state level, ALMBIH)
At state level, a medical device may be placed on the market in Bosnia and Herzegovina only once it has been entered in the Register of medical devices kept by the Agency for Medicinal Prod…
Republika Srpska entity law requires a separate entity register of medical devices in circulation in the entity
At the level of the Republika Srpska entity, the entity Law on Medicines and Medical Devices requires the Agency for Medicines and Medical Devices of Republika Srpska to keep a register of…
6 source-linked facts
Checked 2026-09-16
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D19

Clinical investigation & performance

Verified
Clinical investigation must be registered with the Agency; silence for 30 days permits commencement
Before clinical investigation of a medical device begins on the territory of BiH, the intended investigation must be registered with the Agency. The applicant may be the sponsor of the inve…
1 source-linked fact
Checked 2026-09-16
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D20

Special access & derogation

Verified
Devices for clinical investigation and custom-made devices are exempt from marking
It is not necessary to mark medical devices that are intended for clinical investigation, or that are made to order for an individual patient or user.
1 source-linked fact
Checked 2026-09-16
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D21

Manufacturer PMS

Verified
Manufacturer must keep the vigilance-system data current (lifecycle update duty)
At state level, manufacturers and holders of an entry in the Register of medical devices of BiH are required to regularly update the data on the persons responsible for vigilance, as well a…
Manufacturer must record ALL adverse occurrences and safety corrective actions, including non-reportable ones
At state level, manufacturers and holders of an entry in the Register of medical devices of Bosnia and Herzegovina are required to keep a record of all adverse occurrences and safety correc…
6 source-linked facts
Checked 2026-09-16
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D22

Vigilance & incident reporting

Verified
Manufacturers, distributors and health institutions must report adverse effects to the Agency
Manufacturers, distributors and health institutions are obliged to report to the Agency every observed undesirable or harmful effect caused by medical devices, in accordance with the condit…
Materiovigilance applies the Act's pharmacovigilance provisions to medical devices
The provisions of Article 72(1) of the Act relating to pharmacovigilance apply correspondingly to medical devices, that is to the materiovigilance procedure. The manner of and procedure for…
2 source-linked facts
Checked 2026-09-16
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D23

Recall, FSCA & market surveillance

Verified
Inspectors may prohibit marketing of non-conforming or mislabelled devices and of non-compliant operators
In market surveillance of medical devices an Agency inspector may temporarily prohibit the manufacture, testing and marketing of medical devices for failure to meet the prescribed condition…
Marketing of withdrawn or defective devices is prohibited and disposal is at the owner's cost
Marketing of medical devices that are no longer in use or that are defective is not permitted. Medical devices that are no longer in use are disposed of at the cost of the owner or of the l…
2 source-linked facts
Checked 2026-09-16
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D24

Advertising, claims & promotion

Verified
Medical device advertising follows the Act's medicinal-product advertising provisions
The provisions of Articles 73, 74, 75, 76 and 77 of the Act, which relate to the advertising of medicinal products, apply correspondingly to medical devices. The conditions and manner of ad…
1 source-linked fact
Checked 2026-09-16
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D25

Submission communications & appeal

Verified
No appeal against the registration certificate or the classification decision; administrative dispute only
No appeal is permitted against the Agency's certificate of entry in the Register of medical devices; an administrative dispute may however be brought (Član 65. stav (9)). The same applies t…
1 source-linked fact
Checked 2026-09-16
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Government fees

Full fee schedule (17 lines) →

ALMBiH registration fees in BAM · reviewed 2026-09-16

Fee lineAmountProvenance
Entry in the Register of medical devices, Class I — up to 25 products by protected or generic name in the applicationBAM 200Verified
Entry in the Register of medical devices, Class I — over 100 products by protected or generic name in the applicationBAM 100Verified
Entry in the Register of medical devices, Classes IIa and IIb — up to 25 products by protected or generic name in the applicationBAM 400Verified
Entry in the Register of medical devices, Classes IIa and IIb — over 100 products by protected or generic name in the applicationBAM 300Verified
13 more fee lines on the full schedule · 17 of 17 rows source-verified

Registration timeline

Full registration timeline →

Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (ALMBiH) review clocks and planning ranges · Two national axes: medical devices in classes I, II-a, II-b and III (Law čl. 99(1), Pravilnik čl. 4(1)); in vitro diagnostic devices in lists A, B, C and D (Pravilnik čl. 4(4) and 5(3)), where list A is the highest-risk list classification

Class / pathwayReview clockPlanning totalProvenance
Class I — entry in the ALMBIH Register of medical devices(Application for entry in the Register of medical devices filed with the Agency by a manufacturer seated in BiH or by a legal person representing a foreign manufacturer and seated in BiH, with the manufacturer's own declaration of conformity (Law čl. 101(2)(a)))

ÄŚl. 65(9) of the Pravilnik gives the Agency 90 days from receipt of a complete application to issue the certificate of entry, and the period is not expressed per class, which is why the row is bound to the route.

No appeal lies against the certificate, but an administrative dispute may be brought before the competent court (ÄŤl. 65(9)).

ÄŚl. 66(1) and (3) mean the clock only runs on a formally complete application: an incomplete request is returned for supplementation in a set period, and if it is not supplemented the Agency rejects it by conclusion (ÄŤl. 66(4)).

The exemption is limited to the class link. The class axis itself is published in the classification dataset, and the pathway differs by class in a way the clock does not.

90 days3-7 monthsVerified
Classes II-a, II-b and III — entry in the ALMBIH Register of medical devices(Application for entry in the Register of medical devices after conformity has been determined by an authorised institution, or by the Agency's Commission for Medical Devices where no authorised institution exists (Law čl. 101(2)(b) and the closing paragraph of čl. 101))

The same ÄŤl. 65(9) clock of 90 days applies to Classes II-a, II-b and III; the Pravilnik fixes no separate period per class.

The clock covers the Agency's administrative decision only. The conformity assessment that precedes it is performed by an authorised institution or by the Commission for Medical Devices under Law ÄŤl. 101(2)(b), and neither the Law nor the Pravilnik fixes its duration.

Sterile Class I devices and Class I devices with a measuring function are assessed as Class II or III under Law ÄŤl. 101(2)(a), so they fall on this route even though their nominal class is I.

90 days5-10 monthsVerified
Clinical investigation of a medical device — tacit approval(Notification of a clinical investigation to the Agency by the manufacturer or the importer of the medical device (Law čl. 120(1)))

Čl. 118(1) of the Law provides that if the applicant receives no negative response from the Agency within 30 days of receipt of the notification, the clinical investigation may begin — a tacit-approval clock, not an express approval.

ÄŚl. 118(2) requires the Agency, within 30 days of a complete notification, to give the reasons for refusal by decision, which is final in the administrative procedure with no appeal but is subject to an administrative dispute.

ÄŚl. 118(3) stops the clock on the day the Agency requests supplementary data or explanations and restarts it only when the request is satisfied.

The clinical-investigation fee is 3,000 KM for the authorisation and 1,000 KM for the notification of a device already entered in the Register (Pravilnik 70/09 ÄŤl. 21(a) and (b)).

30 days2-4 monthsVerified
  1. 1Pre-Submission Preparation(1-3 months)
  2. 2Application Submission(1-2 weeks)
  3. 3Administrative Review(2-4 weeks)
  4. 4Technical Evaluation(90 days)
  5. 5Registration Approval(1-2 weeks)

Key regulations

All 6 Bosnia and Herzegovina regulations →

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

Uputstvo od 27.08.2025Uputstvo o uslovima i načinu priznavanja Izjave proizvođača o usklađenosti medicinskog sredstva („Declaration of Conformity“) usljed prelaska EU direktiva (MDD) na EU regulativu (MDR)
RegistrationVerified
ALMBIH, Spisak od 30.10.2025Spisak neophodne dokumentacije za izmjenu i/ili dopunu upisa u Registar medicinskih sredstava (30 October 2025)
RegistrationVerified
Uputstvo od 06.02.2025Uputstvo o uslovima i načinu priznavanja sertifikata o usaglašenosti medicinskih sredstava (EC sertifikat) usljed prelaska EU direktiva (MDD/AIMD) na EU regulativu (MDR)
RegistrationVerified
ALMBIH MSU-1.2, izdanje 0.9.2, sekcija 2Potrebna dokumentacija za upis medicinskog sredstva u Registar (MSU-1.2, section 2 — documentation required for entry in the Register)
RegistrationVerified
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