ALMBiH · structured requirements

🇧🇦 Bosnia and Herzegovina medical device regulatory data

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

52 facts22 dimensions12 official sourceslatest verification 2026-09-16

Advertising, claims & promotion

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

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Medical device advertising follows the Act's medicinal-product advertising provisions

advertising.device-advertising-follows-medicinal-product-rules

Fact-level verified

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 advertising medical devices to the professional public, the level and direction of education and other conditions to be met by persons informing the professional public, and the conditions and manner of advertising medical devices to the general public, are prescribed by the Minister of Civil Affairs of BiH on the proposal of the Expert Council of the Agency.

Original (bs): as quoted. Translation: '(1) The provisions of Articles 73, 74, 75, 76 and 77 of this Act, which relate to the advertising of medicines, apply correspondingly to medical devices. (2) The conditions and manner of advertising medical devices to the professional public, the level and direction of education and other conditions to be met by persons informing the professional public, and the conditions and manner of advertising medical devices to the wider public, are prescribed by the Minister of Civil Affairs of BiH on the proposal of the Expert Council of the Agency.' The Agency also publishes its own guidance on advertising medical devices (Vodic za oglasavanje medicinskih sredstava). Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Approval validity & renewal

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

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The holder must renew expired certificates within 30 days or the device is deleted from the Register

renewal.expired-supporting-documents-must-be-renewed-within-thirty-days

Fact-level verified

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 submitting a certificate that bears only an issue date must submit a new certificate to the Agency within five years of the date of issue. If the validity of expired documents is not renewed and they are not submitted to the Agency within the prescribed period, the Agency deletes the medical device from the Register by a conclusion.

Conditions

The MDR transition guidances of 06.02.2025 and 27.08.2025 both close with the reminder that under Pravilnik Član 70 manufacturers or their representatives are obliged regularly to renew expired documentation.

Original (bs): as quoted. Translation: '(3) 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. (4) Manufacturers or representatives of manufacturers who submit a certificate bearing only the date of issue are obliged to submit a new certificate to the Agency within five years of the date of issue. (5) If the validity of expired documents is not renewed and they are not submitted to the Agency within the prescribed period, the Agency shall delete the medical device from the Register by a conclusion.' The Agency's transition guidances repeat this duty for the MDR transition documents.

Registration certificate is valid for five years

renewal.registration-certificate-valid-five-years

Fact-level verified

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 certificate of entry in the Register of medical devices is five years from the date of issuance.

Original (bs): as quoted. Translation: '(1) By the Agency's certificate of entry of the medical device in the Register the applicant acquires the right to place the medical device on the market until the expiry of the certificate. (2) The period of the certificate of entry in the Register of medical devices is five years from the date of issuance of the certificate of entry in the Register of medical devices.' The renewal application must contain the class-specific form marked as a renewal, the expired certificates, proof of payment of the re-registration costs and of the administrative charges, and a copy of the previously issued decision/certificate (Član 72).

Authority & regime

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

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ALMBiH is the state-level competent authority for medical devices

authority.competent-authority-and-device-remit

Fact-level verified

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 Bosne i Hercegovine, ALMBiH), a state-level body. Under Article 8 of the Act its device remit comprises keeping the register of medical devices for the territory of BiH, the register of manufacturers of medical devices and the register of legal entities engaged in wholesale distribution; issuing the certificates of entry in those registers; collecting, analysing and responding to undesirable occurrences in the application of medical devices (materiovigilance); participating in conformity assessment and marking of medical devices in BiH against harmonised European standards and the technical regulations made under the Law on Technical Requirements for Products and Conformity Assessment; and professional inspection and supervision of the manufacture and wholesale marketing of medical devices.

Original (bs): as quoted in part. Translation: 'Article 8 (Scope of the Agency in the field of medical devices) The scope of the Agency in the field of medical devices comprises: a) keeping the register of medical devices for the territory of BiH; b) keeping the register of manufacturers of medical devices for the territory of BiH; c) keeping the register of legal persons engaged in wholesale trade in medical devices for the territory of BiH; d) issuing the certificate of entry in the register of manufacturers of medical devices; e) issuing the certificate of entry in the register of legal persons engaged in wholesale trade in medical devices; f) issuing the certificate of entry in the register of medical devices; g) collecting, analysing and responding to undesirable occurrences in the application of medical devices, i.e. materiovigilance of medical devices; ... i) professional inspection and supervision of the manufacture and wholesale marketing of medical devices.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Premises, personnel and retail inspection are Entity and Brčko District competences, not the state agency's

authority.entity-and-brcko-district-competence

Fact-level verified

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 medical devices, are prescribed by the two Entities (Federation of Bosnia and Herzegovina and Republika Srpska) and by Brčko District, not by the state-level Agency. The state Act and the Ordinance set the registration, conformity, marking, wholesale and vigilance rules; the Entities and Brčko District set the facility-level conditions.

Original (bs): as quoted from Član 104. stav (2) and Član 124. stav (4); Član 111. stav (2) states the same for retail ('Uslovi za obavljanje prometa medicinskih sredstava u vezi s prostorom, opremom i kadrom utvrđuju se propisima entiteta, odnosno Brčko Distrikta'). Translation: 'Conditions relating to the characteristics of premises, equipment and personnel, in accordance with this Act, are prescribed by the Entities, i.e. Brčko District.' / 'Pharmaceutical-inspection supervision of retail trade in medicines and medical devices is regulated by the law of the Entities, i.e. Brčko District.'

Change control

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

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Manufacturer name or address amendments require updated conformity and representation documents

change.amendment-request-must-include-updated-ec-certificate-and-authorisation

Fact-level verified

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 authorises the performance of tasks relating to the entry of the device in the Register on the territory of Bosnia and Herzegovina (original or notarised copy in the manufacturer's country), the certificate of conformity (EC certificate), the certificate of conformity (EC Design Examination) where applicable, the manufacturer's declaration of conformity against the European directive, and proof that the device is marketed in the manufacturer's country or in one of the EU countries ('Free Sale Certificate' or similar document), each as an original or a notarised copy in the manufacturer's country. A request for amendment may relate to only one certificate of entry; a request for supplement (dopuna) may likewise relate to only one certificate and only to devices covered by a single declaration of conformity sharing the same GMDN, EMDN or EDMA code.

Conditions

A request for amendment or supplement may relate to only one certificate of entry in the Register.
Where a place of manufacture also changes, a separate request must be filed for the change of manufacturing site, supported by an ISO quality-system certificate covering that site.

Original (bs): as quoted. Translation: '6. Updated letter of authorisation by which the manufacturer authorises the performance of tasks relating to the entry of the medical device in the Register on the territory of Bosnia and Herzegovina, original or notarised copy in the manufacturer's country; 7. Certificate of conformity (EC), original or notarised copy in the manufacturer's country; 8. Certificate of conformity (EC — Design Examination), original or notarised copy in the manufacturer's country; 9. Manufacturer's declaration of conformity of the medical device with the European directive (Declaration of Conformity), original or notarised copy in the manufacturer's country; 10. Proof that the medical device is marketed in the manufacturer's country or in one of the EU countries (Free Sale Certificate or similar document).' The same list is stated for the supplement of an entry (adding models, dimensions, pack sizes or catalogue numbers), and the closing note directs that where the validity of an EC certificate under 93/42/EC or 98/79/EC is extended, the Agency's EC-certificate and declaration-of-conformity transition guidances are to be followed.

The certificate holder must notify the Agency in writing of every change and apply for amendment

change.holder-must-notify-agency-of-every-change

Fact-level verified

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 documentation. One or more amendments may be applied for. The changes that must be applied for are enumerated and include: change of the manufacturer's name and/or address; change of the name and/or address of the certificate holder; change of the certificate holder; change of the device names; change of the device manufacturer; change, deletion or addition of a place of manufacture; changes in the finished-product test procedure (change of standards and methods); change of the appearance and method of labelling of the outer and/or immediate packaging; amendment of the form, packaging or dimensions of the device; change of the device class; change of the period of use; change of storage conditions; change in the method and place of issue of the device; and other changes.

Original (bs): as quoted in part. Translation: '(1) During the period of validity of the certificate of entry in the register of medical devices, the certificate holder is obliged to inform the Agency in writing of every change, renewal or amendment of the issued certificate or of the submitted documentation. ... (3) The certificate holder applies for the following changes: a) change of the name and/or address of the manufacturer of the medical device; b) change of the name and/or address of the holder of the certificate of entry in the Register of medical devices; c) change of the holder of the certificate of entry in the Register of medical devices; d) change of the names of medical devices; e) change of the manufacturer of the medical device.'

Classification rules

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

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Four risk classes: I, IIa, IIb and III, plus separate IVD lists

classification.four-risk-classes-i-iia-iib-iii

Fact-level verified

Medical devices are classified by the degree of risk to the user into Class I (low risk), Class IIa (higher risk), Class IIb (high risk) and Class III (highest risk). Devices are additionally classified by their nature, energy coupling and other properties as non-invasive, invasive and active. In vitro diagnostic medical devices are classified separately into List A and List B (for use by professionals only), devices for self-diagnosis, and all other in vitro diagnostic devices.

Original (bs): as quoted. Translation: '(1) Medical devices are classified, according to the degree of risk to the user, into: a) Class I — medical devices with a low degree of risk; b) Class IIa — medical devices with a higher degree of risk; c) Class IIb — medical devices with a high degree of risk; d) Class III — medical devices with the highest degree of risk.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Clinical investigation & performance

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

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Clinical investigation must be registered with the Agency; silence for 30 days permits commencement

clinical-investigation.registration-with-agency-and-thirty-day-tacit-approval

Fact-level verified

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 investigation or, on its behalf, the principal investigator. If the applicant does not receive a negative response from the Agency within 30 days of receipt of the registration, it is considered that the clinical investigation may begin. The Agency must, no later than 30 days after receipt of a complete registration, inform the applicant of the reasons for rejection by a decision that is final in the administrative procedure, against which no appeal is permitted but an administrative dispute may be brought before the competent court. The period stops running on the day the Agency requests additional data or explanations and resumes when the request is met.

Conditions

An applicant may be a manufacturer or an importer of the medical device (Član 120. stav (1)).
The legal person performing the investigation and the sponsor must insure their liability for damage to participants before the investigation begins (Član 116).
Clinical investigation of a medical device may not be performed at the expense of the compulsory health insurance fund (Član 114. stav (2)).

Original (bs): as quoted. Translation: 'Article 118. (1) If the applicant for registration of a clinical investigation of a medical device does not receive a negative response from the Agency within 30 days from the day of receipt of the application, it is considered that it may begin the clinical investigation of the medical device.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Device definition & scope

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

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Medical device definition: instruments, apparatus, material and other products; IVDs covered separately

scope.medical-device-definition-and-included-products

Fact-level verified

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, immunological or metabolic means but are used alone or in combination — including the software needed for their proper use — for diagnosis, prevention, monitoring, treatment or alleviation of disease; for diagnosis, monitoring, treatment or alleviation of injury or disability; for investigation, replacement or modification of anatomical or physiological functions; or for control of conception. Products the manufacturer intended for use in combination with a device, devices made to the individual prescription of a specially qualified professional, and devices intended for clinical investigation are also counted as medical devices. In vitro diagnostic medical devices are defined separately as reagents, reagent kits, reagent products, control and calibration materials, instruments and equipment used in vitro on biological samples.

Original (bs): as quoted in part. Translation: '(1) For the purposes of this Act, medical devices are: instruments, apparatus, material and other products applied to humans which do not achieve their principal intended action, determined by the manufacturer, by pharmacological, immunological or metabolic activity, but are used alone or in combination, including the software needed for proper use, for the purpose of: a) diagnosis, prevention, monitoring, treatment or alleviation of the causes or consequences of disease; b) diagnosis, monitoring, treatment or alleviation of injuries ...; c) investigation, replacement or modification of anatomical or physiological functions; d) control of conception.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Dossier requirements

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

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Insurance policy covering user damage is a mandatory dossier item

dossier.insurance-policy-for-user-damage

Fact-level verified

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 representative must submit complete information on the manufacturer's liability insurance valid on the territory of Bosnia and Herzegovina. The Agency's applicant guidance requires the policy to be issued by an insurance company registered in Bosnia and Herzegovina and to be made out to the applicant, as an original or a municipal or notarised copy.

Original (bs): as quoted. Translation: 'f) an insurance policy as proof of insurance of users against damage arising in the application of the medical device'. The additional detail on the insurer being registered in BiH comes from the Agency's applicant guidance, section B ('Polisa i ISO sertifikati').

ISO 9001:2015 and ISO 13485:2016 certificates required except for Class I devices

dossier.iso-9001-and-iso-13485-certificates-except-class-i

Fact-level verified

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 management systems — requirements) and ISO 13485:2016 (medical devices — quality management systems — requirements for regulatory purposes).

Conditions

This is an operational restatement of Pravilnik Član 68. stav (1) tačka g) ('potvrdu o sustavu kvalitete, izuzev za medicinska sredstva klase I') in the Agency's own applicant guidance.

Original (bs): as quoted. Translation: 'A certificate of the quality system (ISO certificate), except for medical devices of class I, namely: o ISO 9001:2015 Quality management systems — Requirements; o ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes.'

Registration dossier: representation proof, EC certificate, declaration of conformity, free-sale proof, insurance, QMS certificate, IFU

dossier.required-documents-for-class-i-to-iii-registration

Fact-level verified

For a class I, IIa, IIb or III medical device the registration dossier must contain, besides the class-specific application form and Annex 1: proof of authorised representation of the manufacturer on the territory of BiH (representation contract or letter of authorisation, original or certified copy); the certificate of conformity with the directives and regulations of the European Union (CE marking certificate, EC certificate), except for class I devices, original or certified copy in the country of origin; the manufacturer's declaration of conformity against the European directive stating the exact class, original or certified copy in the country of origin; proof that the device is marketed in the manufacturer's country or in an EU member state; an insurance policy covering damage to users arising from the application of the device; certification of the quality system, except for class I devices; a certificate of conformity of sterile products and a description of the sterilisation method and sterility control tests for sterile devices; information on the device (composition, brief product description, declared purpose); details of the proposed shelf life and storage conditions; packaging, form, material and composition; instructions for use in a foreign language for foreign-origin products and a proposed instruction in one of the official languages of BiH; confirmation of measuring conformity for devices with a measuring function; and proof of payment of the Agency's registration fee and the administrative charge.

Conditions

A Class I device (not sterile, without measuring function) is exempt from the EC-certificate limb and from the quality-system certificate requirement.
Documents originating abroad must be originals or copies certified in the country of origin.

Original (bs): as quoted in part (the full list runs from tačka a) to tačka p)). English summary given in the value. The 2018 applicant guidance (ALMBIH MSU-1.2) organises the same dossier into four binders: A request, authorisation and fees; B insurance policy and ISO certificates; C device-specific data including the EC certificate, declaration of conformity and free-sale proof; D general and technical data. Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Economic-operator roles

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

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Where the device is manufactured abroad the BiH supplier/importer assumes the manufacturer's duties

operator.importer-assumes-manufacturer-duties-for-foreign-made-devices

Fact-level verified

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. These duties include submitting to the Agency the documentation demonstrating that the quality assurance system and protection of public health are in place and that the device has been manufactured in accordance with the general and special requirements, submitting the documentation on design, quality control and maintenance, and reporting to the Agency any changes in the manufacturing process or in the specifications of the device.

Original (bs): as quoted. Translation: '(4) In the case where the medical device is manufactured abroad, the duty of the manufacturer is assumed by the supplier/importer of the medical device in BiH.' Paragraphs (1) to (3) set out the duties being assumed.

The manufacturer's representative must have its authorisation registered with the Ministry of Foreign Trade

operator.representative-authorisation-registered-with-ministry

Fact-level verified

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 Relations of BiH. The manufacturer or the authorised representative must also submit complete information on the manufacturer's liability insurance for possible damage caused to the user of the device, valid on the territory of Bosnia and Herzegovina.

Original (bs): as quoted. Translation: '(6) A manufacturer's representative is obliged to have the manufacturer's authorisation or a representation contract registered with the Ministry of Foreign Trade and Economic Relations of BiH. (7) The manufacturer or the authorised representative is obliged to submit complete information on insurance of the manufacturer's liability for possible damage caused to the user of the medical device, valid on the territory of BiH.'

Establishment, import & distribution

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

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Retail may only procure from registered wholesalers or registered manufacturers

establishment.retail-only-from-registered-wholesalers-or-manufacturers

Fact-level verified

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 manufacturer entered in the register kept by the Agency, and may market a device only if it is entered in the register of medical devices with the Agency. Conditions concerning premises, equipment and personnel for retail are prescribed by the Entities or Brčko District.

Original (bs): as quoted. Translation: '(1) A legal and natural person engaged in retail trade in medical devices in specialised shops may procure medical devices only from wholesalers of medical devices, that is from a manufacturer entered in the register with the Agency, and may trade in a medical device only if it is entered in the register of medical devices with the Agency.'

Wholesale distribution requires prior registration of the activity with the Agency

establishment.wholesale-activity-must-be-registered-with-agency

Fact-level verified

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 the register of legal entities engaged in the wholesale distribution of medical devices. Wholesale distribution of medical devices comprises procurement, storage, transport and sale of medical devices, including import and export.

Original (bs): as quoted. Translation: '(1) Wholesale trade in medical devices comprises procurement, storage, transport and sale of medical devices, including export and import. ... Article 109. A legal person engaged in wholesale trade in medical devices must, in addition to the general legal conditions, also satisfy the special conditions laid down by this Act, that is it is obliged to: a) register its activity with the Agency before the start of wholesale trade in medical devices, the Agency considering the application and keeping the register of legal persons engaged in wholesale trade in medical devices.'

Wholesale distributor must employ a materiovigilance officer and a distribution officer

establishment.wholesale-responsible-person-requirements

Fact-level verified

A legal entity engaged in wholesale distribution must employ a responsible person with at least level VI of medical education who is charged with monitoring and reporting undesirable occurrences in the application of medical devices and responding to them, that is with materiovigilance, and must also employ a responsible person for the distribution of medical devices with adequate knowledge to take on that responsibility. It must additionally carry on its activity with a quality assurance system and protection of public health in place; the detailed good-distribution-practice conditions are set by the separate Ordinance on Good Distribution Practice (Sl. glasnik BiH 75/18).

Original (bs): as quoted. Translation: 'b) perform its activity so that a quality assurance system and protection of public health are introduced; c) employ a responsible person with at least level VI of medical education who is obliged to monitor and report undesirable occurrences in the application of medical devices and to respond to them, that is who is charged with materiovigilance; d) employ a responsible person for the distribution of medical devices with adequate knowledge to take on that responsibility.'

Label, IFU & language

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

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Registration requires the foreign-language IFU plus a proposed IFU in an official language of BiH

label.ifu-language-proposal-submitted-with-registration

Fact-level verified

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 instruction in one of the languages in official use in Bosnia and Herzegovina. The same requirement applies to in vitro diagnostic medical devices.

Original (bs): as quoted. Translation: 'm) instructions for use in a foreign language for products of foreign origin and a proposed instruction in one of the languages in official use in BiH'. The Agency's documentation list restates this for amendment requests as 'Originalno uputstvo za upotrebu medicinskih sredstava i prijedlog uputstva na jednom od jezika u službenoj upotrebi u BiH'.

Instructions for use not required for class I and IIa devices usable safely without them, or for professional use

label.ifu-not-required-for-class-i-iia-and-professional-use

Fact-level verified

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 for medical devices handled by professional staff.

Original (bs): as quoted. Translation: '(5) Exceptionally, instructions are not required for medical devices of class I and IIa if they can be used safely without instructions. Instructions are also not required for medical devices handled by professional staff.' The requirement that the packaging be marked in an official language of BiH is not disapplied by this provision.

Labelling on outer and immediate packaging and the IFU must be in an official language of BiH

label.official-language-required-on-packaging-and-ifu

Fact-level verified

Every medical device marketed in Bosnia and Herzegovina must be marked as such on the outer and immediate packaging in one of the languages in official use in BiH and must have instructions for use enclosed. The instructions for use must be written in one of the official languages of Bosnia and Herzegovina in an understandable manner allowing proper and safe use, and under Pravilnik Član 55. stav (2) must contain the packaging particulars (except batch number and expiry), information on the device's action and possible adverse effects, its behaviour in combination with other devices, measures for effective and safe operation, calibration and maintenance, implantation information, interaction risks, instructions for damaged sterile packaging and re-sterilisation, reprocessing procedures and limits for reusable devices, and radiation data for emitting devices. (Zakon 58/08 Član 113. stav (3) separately requires at least information on undesirable occurrences during use, a detailed description of installation and of checking correct use.)

Conditions

The list of mandatory packaging information is set out in Pravilnik Član 54 (name and address of manufacturer or importer/distributor; name and information on the device and its purpose; batch number and date of manufacture; expiry date; 'sterile' with the sterilisation method; 'single use'; 'custom made'; clinical-trial and research-use wordings; storage and transport conditions; safety measures; batch number of removable parts; intended use where not obvious).

Original (bs): as quoted. Translation: '(1) Every medical device in trade in BiH must be marked as such on the outer and inner packaging in one of the languages in official use in BiH and have instructions for use attached. ... Article 55. (1) The instructions for use must be written in one of the official languages of Bosnia and Herzegovina, in an understandable manner enabling the user proper and safe use.' The Act states the same rule in Član 113.

Legal basis & guidance

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

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Ordinance on Medical Devices (Official Gazette of BiH No. 4/10) made under the Act No. 58/08

legal-basis.medical-devices-ordinance-in-force

Fact-level verified

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 January 2010. It was adopted by the Minister of Civil Affairs of BiH on the proposal of the Expert Council of the Agency, on the basis of Article 99(7), Article 100(4), Article 106(5), Article 112(3) and Article 113(4) of the Law on Medicinal Products and Medical Devices of Bosnia and Herzegovina (Official Gazette of BiH No. 58/08).

Original (bs): as quoted. Translation: 'On the basis of Article 99(7), Article 100(4), Article 106(5), Article 112(3) and Article 113(4) of the Law on Medicinal Products and Medical Devices of Bosnia and Herzegovina (Official Gazette of BiH, No. 58/08), the Minister of Civil Affairs of Bosnia and Herzegovina, on the proposal of the Expert Council of the Agency for Medicines and Medical Devices of Bosnia and Herzegovina, adopts the ORDINANCE ON MEDICAL DEVICES.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

The Ordinance applies until regulations transposing the relevant EU directives are adopted

legal-basis.ordinance-applies-until-eu-directive-transposition

Fact-level verified

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 Union directives are adopted. That transposition has not been completed, which is why the Agency has instead issued transition guidances applying the MDR and IVDR transition periods administratively within the existing 2010 framework.

Conditions

The instrument in force is still the 2010 Ordinance; the MDR/IVDR rules reach BiH practice through the Agency's Article 120 transition guidances rather than through a transposing national act.

Original (bs): as quoted. Translation: 'This Ordinance enters into force on the eighth day from the day of publication in the Official Gazette of BiH, and shall apply until the adoption of regulations transposing the relevant European Union directives.' The continuing application of this instrument in 2026 is corroborated by the Agency's transition guidances of 06.02.2025 and 27.08.2025, which are expressly grounded on Article 120 of Regulation (EU) 2017/745 together with Articles 100 and 101 of the Act and Article 68 of the Ordinance.

Manufacturer PMS

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

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Manufacturer must keep the vigilance-system data current (lifecycle update duty)

postmarket.manufacturer-keeps-vigilance-system-data-current

Fact-level verified

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 as the data on other changes that may affect the vigilance system.

Conditions

The duty is on the manufacturer and on the holder of the entry in the Register of medical devices of BiH.
The same article requires them to make sure that everyone involved in putting the device into circulation continuously receives all necessary information about adverse occurrences and safety corrective actions (Član 6. stav (3) tačka (f)).

Effective from 2012-08-07

State-level ordinance of the state Agency ALMBIH (Službeni glasnik BiH 58/12, in force 7 August 2012). Bosnian source text in standard Latin orthography. This is the lifecycle-update limb of D21: a continuing duty to maintain the vigilance system and its responsible-person data rather than a one-off filing.

Manufacturer must record ALL adverse occurrences and safety corrective actions, including non-reportable ones

postmarket.manufacturer-records-all-adverse-occurrences-including-non-reportable

Fact-level verified

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 corrective actions, including the adverse occurrences that do not meet the criteria for reporting. The same article requires them to determine, on becoming aware of an adverse occurrence connected with a device they market, whether it is an occurrence that must be reported — and to report it even where it is not established with certainty that it is harmful — to investigate occurrences and take the necessary corrective actions, and to deliver a final report at the end of the investigation.

Conditions

The duty is on the manufacturer and on the nositelj upisa (holder of the entry in the Register of medical devices of BiH).
This record-keeping duty is distinct from the reporting duty in the same article: the record must also cover occurrences that fall below the reporting threshold.

Effective from 2012-08-07

State-level ordinance of the state Agency ALMBIH (Službeni glasnik BiH 58/12, in force 7 August 2012), applying throughout Bosnia and Herzegovina. Bosnian source text in standard Latin orthography. This is the closest thing to a PMS record-keeping duty found in the state instrument set: it is a duty to hold and maintain a complete adverse-occurrence and corrective-action record, not a named "PMS plan" — see unresolved.D21.

Non-reportable misuse must be handled inside the manufacturer's own quality and risk-management system

postmarket.non-reportable-events-handled-in-manufacturer-quality-and-risk-system

Fact-level verified

At state level, misuse of a medical device that has not led to death, to serious deterioration of health or to a serious threat to public health need not be reported to the Agency. Such occurrences must be resolved within the manufacturer's own quality and risk-management system, and the decision not to report must be justified and documented and, on request, made available to the Agency. The manufacturer is also required to report to the Agency a significant change of trend in misuse — an increase in frequency or a significant change in the cause of a problem that could potentially lead to death or serious deterioration of health — and to report misuse where it initiates a corrective action to prevent death or serious endangerment of health.

Conditions

The duty-bearer is the manufacturer (proizvođač).
The justification for not reporting must be documented and available to the Agency on request — an express documentation duty, not merely an internal practice.

Effective from 2012-08-07

State-level ordinance of the state Agency ALMBIH (Službeni glasnik BiH 58/12, in force 7 August 2012). Bosnian source text in standard Latin orthography. This is the express "have a system" limb of D21 found in the state instrument set: the ordinance requires the manufacturer to absorb below-threshold events into its own quality and risk-management system rather than into the vigilance report stream.

Agency may accept a periodic report from the manufacturer, on a form and at a frequency agreed with the Agency

postmarket.periodic-report-form-and-frequency-agreed-with-agency

Fact-level verified

At state level the Agency may accept a periodic report or a trend report from the manufacturer after one or more reports have been assessed by the manufacturer and the Agency. The manufacturer and the Agency agree the form and the frequency of reporting for particular types of medical device and adverse occurrence. Periodic or trend reporting is acceptable where the manufacturer has issued a safety notice about an adverse occurrence and carried out safety corrective actions, or where the occurrences are common and well documented in agreement with the Agency.

Conditions

This is a periodic-reporting arrangement agreed case by case with the Agency, not a fixed statutory reporting interval.
Where the manufacturer has agreed with the Agency to move to periodic summary reporting or trend reporting, it must inform the other competent authorities concerned.
The duty-bearer is the manufacturer (proizvođač).

Effective from 2012-08-07

State-level ordinance of the state Agency ALMBIH (Službeni glasnik BiH 58/12, in force 7 August 2012), applying throughout Bosnia and Herzegovina. Bosnian source text in standard Latin orthography.

Trend report must be submitted to the Agency on a significant increase in occurrence frequency

postmarket.trend-report-must-be-submitted-on-significant-increase

Fact-level verified

At state level a trend report must be delivered to the Agency when there is a significant increase in the frequency of: (a) adverse occurrences that have already been reported; (b) adverse occurrences within Član 10 of the ordinance (the occurrences that need not be reported); and (c) occurrences that are not normally reported. Where an occurrence of a type previously judged to carry a negligible risk nevertheless results in death or significant deterioration of health, it must be reported and the risk reassessed, and those decisions must be documented; the Agency must be informed of changes in the trend of such events, most often an increase.

Conditions

The duty-bearer is the manufacturer (proizvođač), which reports to the Agency.
Trend reporting is the reporting route the manufacturer uses on a significant increase in the number of events that are not normally regarded as adverse occurrences and for which a pre-determined reporting threshold is used (definition in Član 4. tačka (13) of the same ordinance).

Effective from 2012-08-07

State-level ordinance of the state Agency ALMBIH (Službeni glasnik BiH 58/12, in force 7 August 2012). Bosnian source text in standard Latin orthography.

Post-market device vigilance system must be run by a qualified responsible person at the manufacturer or its representative

postmarket.vigilance-system-responsible-person-at-manufacturer-or-representative

Fact-level verified

At state level the responsible person for medical-device vigilance is the person who is responsible for establishing and operating the vigilance system at the manufacturer or at the manufacturer's representative, and that person must have a VIth level of professional qualification. The obligations of the manufacturer and of the holder of an entry in the Register of medical devices of BiH are set out in the same article.

Conditions

The duty attaches to the manufacturer (proizvođač) or to the manufacturer's representative (njegov zastupnik).
The responsible person must hold a VIth degree of professional qualification (VI stepen stručnosti).
The manufacturer is separately required to keep its representative in BiH promptly informed about adverse occurrences (Član 6. stav (2)).

Effective from 2012-08-07

State-level ordinance, adopted by the Stručno vijeće of the state Agency ALMBIH under Član 121 of the state Law 58/08; it therefore applies throughout Bosnia and Herzegovina. Published in Službeni glasnik BiH 58/12 of 30 July 2012; Član 37 provides that it enters into force on the eighth day after publication. Bosnian source text in standard Latin orthography.

Official forms & portals

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

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Applications must be entered in the Agency's electronic device-sector application

portal.electronic-application-system-required

Fact-level verified

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 for Medical Devices. Where one of the required original documents was already submitted with an earlier application, a copy of the document plus a statement naming the earlier application number is to be supplied. Documentation must be arranged in the stated order in a labelled binder, and the applicant must retain copies of the attached documents in its own archive.

Conditions

The Agency's electronic application is required for the data entry step; the physical dossier is still filed at the Agency's registry office in the prescribed order.

Original (bs): as quoted. Translation: '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 for Medical Devices.' The same note states that only the documentation listed in the current list need be attached, that the Agency may request additional documentation once the request is taken into processing, and that the list will be revised and published on the Agency's website as needed.

QMS, audit & inspection

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

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Agency inspectors may inspect the manufacturer's quality system and suspend marketing of non-conforming devices

inspection.agency-inspector-powers-over-device-manufacture-and-distribution

Fact-level verified

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 necessary, the premises of the supplier or other contracting party of the manufacturer; to order suitable testing and verification of a device to assess its conformity with the Act after it has been placed on the market or put into use; to take samples of a device and order a conformity assessment procedure; temporarily to prohibit the manufacture, testing and marketing of medical devices for failure to meet prescribed conditions or where public health is endangered; temporarily to prohibit marketing of a device marked contrary to the Act; to prohibit marketing of a device that does not meet the prescribed conditions; and temporarily to prohibit the operation of a legal person where the application of a quality system for the device is not insured.

Original (bs): as quoted in part. Translation: 'In carrying out inspection supervision in the field of medical devices, the inspector, in addition to the measures provided in the regulations on market supervision, has the right and the duty to propose the initiation of misdemeanour proceedings, that is to order and undertake the following measures: a) supervise the quality assurance system of the manufacturer of the medical device and, where necessary, the premises of the supplier or other contracting party of the manufacturer; b) order suitable testing and verification of the medical device in order to assess its conformity with the Act and the regulations made under the Act after the device has been placed on the market or put into use; ... d) temporarily prohibit the manufacture, testing and marketing of medical devices for failure to meet prescribed conditions or where public health is endangered.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Recall, FSCA & market surveillance

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

Compare countries

Inspectors may prohibit marketing of non-conforming or mislabelled devices and of non-compliant operators

market-surveillance.inspector-may-suspend-marketing-of-non-conforming-devices

Fact-level verified

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 conditions or where public health is endangered; temporarily prohibit marketing of a device where the device is marked contrary to the Act and the regulations made under it; temporarily prohibit marketing of a device that does not meet the prescribed conditions or in other cases provided by the Act; and temporarily prohibit the operation of a legal person where the application of a quality system for the medical device is not ensured. The inspector may also order the removal of identified irregularities and defects.

Conditions

Inspection of retail trade in medical devices is regulated by Entity and Brčko District law (Act, Član 124. stav (4)).

Original (bs): as quoted. Translation: 'd) temporarily prohibit the manufacture, testing and marketing of medical devices for failure to meet the prescribed conditions or where public health is endangered; e) temporarily prohibit the marketing of a medical device in cases where that medical device is marked contrary to the provisions of this Act and the regulations made under it; f) temporarily prohibit the marketing of a medical device that does not correspond to the prescribed conditions or in other cases provided by this Act; g) temporarily prohibit the operation of a legal person in cases where insurance of the application of the quality system of the medical device is lacking.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Marketing of withdrawn or defective devices is prohibited and disposal is at the owner's cost

recall.withdrawn-or-defective-devices-may-not-be-marketed

Fact-level verified

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 legal or natural person with whom the device was found. Medical waste must be disposed of in a manner that does not endanger the life and health of people or the environment.

Conditions

The Act additionally provides that devices withdrawn from the market are disposed of at the expense of the owner or the person who possessed them (Član 123. stav (2)).

Original (bs): as quoted. Translation: '(1) Trade in medical devices that are no longer in use or that are defective is not permitted. (2) Medical devices that are no longer in use are disposed of at the cost of the owner or of the legal or natural person with whom the medical device was found.' The Act contains the same rule in Član 123.

Registration pathways

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

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The applicant must be a BiH-based manufacturer or a legal person representing the foreign manufacturer

registration.application-by-bih-manufacturer-or-authorised-representative

Fact-level verified

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 representing a foreign manufacturer which has its seat in Bosnia and Herzegovina. A foreign manufacturer cannot apply directly.

Original (bs): as quoted. Translation: '(5) An application for entry in the Register of medical devices is submitted by a manufacturer of medical devices with its seat in BiH or a legal person which represents a foreign manufacturer and has its seat in BiH.' The Agency's 2018 applicant guidance additionally requires a current extract from the court register for the BiH legal person together with the manufacturer's letter of authorisation, original or certified copy legalised in the manufacturer's country.

The Agency issues the registration certificate within 90 days of a complete application

registration.certificate-issued-within-ninety-days

Fact-level verified

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 application. No appeal is permitted against this certificate, but an administrative dispute may be brought.

Original (bs): as quoted. Translation: '(9) The Agency decides on the entry of a medical device in the register of medical devices by a certificate of entry in the Register, which it is obliged to issue within 90 days from the day of receipt of a complete application. No appeal is permitted against this certificate, but an administrative dispute may be initiated.' The 90-day period runs only from a formally complete application (Član 66).

Class-specific application forms REG-MS-KL and REG-IV-MS with Annex 1

registration.class-specific-application-forms

Fact-level verified

A formally complete registration application consists of the completed application form for the register of medical devices of the corresponding class (form REG-MS-KL for general medical devices, form REG-IV-MS for in vitro diagnostic medical devices), signed and certified by the applicant, together with the completed Annex 1 (Dodatak 1) listing the devices. Incomplete applications are returned to the applicant for amendment within a set period; if the applicant does not complete the application within that period the Agency rejects it by a conclusion.

Original (bs): as quoted. Translation: '(2) A formally complete application comprises: a) a completed separate application form for entry in the Register of medical devices of the corresponding class together with form Annex 1; b) the complete documentation prescribed for obtaining the certificate of entry in the Register of medical devices. (3) If the application is not complete the Agency shall designate in writing that the applicant amend it within the period left. (4) If the applicant does not complete the application within the stated period, the Agency shall reject the application by a conclusion.'

Entry in the Register of medical devices is required before a device may be marketed

registration.entry-in-register-required-before-marketing

Fact-level verified

It is prohibited to market medical devices that are not entered in the register of medical devices kept by the Agency, in addition to the prohibition on marketing devices that do not conform to the prescribed general and special requirements (Zakon 58/08, Član 108. stav (2), restated in Pravilnik 71/12, Član 6. stav (2)). Entry in the Register is an administrative procedure conducted by the Agency for the purpose of recording the medical devices on the market in BiH and protecting public health, and it is by that entry that the applicant acquires the right to place the device on the market of Bosnia and Herzegovina (Pravilnik 4/10, Član 65. stav (4) and (8)).

Conditions

Pravilnik 4/10 Član 75. stav (2), which carried the same prohibition, was repealed by Pravilnik 71/12 Član 18.

Original (bs): as quoted from Član 75. stav (2); Član 65. stav (4) adds 'Upis medicinskog sredstva u Registar je administrativni postupak koji provodi Agencija u svrhu evidencije medicinskih sredstava u prometu u BiH, a radi zaštite javnog zdravlja', and Član 65. stav (8) 'Upisom medicinskih sredstava u Registar podnositelj zahtjeva stječe pravo njihovog plasiranja na tržištu Bosne i Hercegovine'. Translation of Član 75. stav (2): 'It is prohibited to market medical devices that are not conform with the prescribed general and special requirements ... that is, to market medical devices that are not entered in the register of medical devices kept by the Agency.'

Reliance & recognition

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

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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.

Bosnia and Herzegovina 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 Bosnia and Herzegovina (8 records)

Bosnia and HerzegovinaEU conformity assessment

Prior approval / evidence record

Proof of marketing in the manufacturer's country or an EU member state is required for registration

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

Fact-level verified

Statement: A registration application for a class I, IIa, IIb or III medical device must include proof that the device is marketed in the country of the manufacturer or in one of the countries of the European Union — a 'Free Sale Certificate' or similar document. This is a mandatory documentary element of the dossier and is required alongside, not instead of, the EU conformity certificate.
Source Approval: Evidence of marketing in the manufacturer's country or in an EU member state (Free Sale Certificate or similar document)
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The limb is satisfied by proof of marketing either in the manufacturer's own country or in an EU member state; a foreign (e.g. FDA) clearance is not recognised as such, but a free-sale certificate from the manufacturer's home market is acceptable evidence of marketing. The document is evidence of marketing, not a recognition of the approval.

Original (bs): as quoted. Translation: 'proof that the medical device is marketed in the country of the manufacturer or in one of the countries of the European Union'. The same requirement is repeated for in vitro diagnostic devices in Član 69. stav (1) tačka e), and restated by the Agency's current documentation list (30.10.2025) as '„Free Sale Certificate“ ili sličan dokument'.

Bosnia and HerzegovinaEU conformity assessment

Prior approval / evidence record

EU CE marking — EC certificate issued under Directives 90/385/EEC or 93/42/EEC

Authority: EU CE marking — EC certificate issued under Directives 90/385/EEC or 93/42/EEC
Accepted: Yes
Benefit: Law čl. 102(3) requires a manufacturer whose conformity is determined by a conformity-assessment body recognised in the EU to affix the CE marking recognised in BiH, and the Agency's Instruction of 6 February 2025 sets out the conditions and documentation for recognising an EC certificate issued under Directive 90/385/EEC or 93/42/EEC that was valid on 26 May 2021 and not withdrawn, including the MDR Annex VII application-and-contract evidence. Recognition is an administrative act of the Agency under čl. 100 and 101 of the Law and čl. 68 of the Pravilnik; it does not replace entry in the Register, which under Pravilnik čl. 65(8) is what confers the right to place the device on the market.

Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10 od 19.01.2010, čl. 65(5)-(9)Zakon o lijekovima i medicinskim sredstvima, Službeni glasnik BiH br. 58/08 od 21.07.2008, čl. 118 Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10, čl. 70 i 71 ALMBIH — Dopuna i izmjena upisa u Registar medicinskih sredstava, spisak dokumentacije, 30.10.2025

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

Bosnia and HerzegovinaEU conformity assessment

Prior approval / evidence record

EU-recognised conformity assessment: CE marking is recognised in Bosnia and Herzegovina

reliance.ce-marking-recognised-in-place-of-national-conformity-marking

Fact-level verified

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 manufacturer marks the device with the CE marking, and that marking is recognised in Bosnia and Herzegovina in place of the national BiH conformity marking. The CE route therefore replaces the national conformity-assessment and marking step, but the device must still be entered in the Register of medical devices kept by the Agency before it may be placed on the market.
Source Approval: EU CE Marking — conformity assessment determined by a body recognised in the EU; in practice an MDR (EU) 2017/745 certificate, or during the transition a legacy MDD 93/42/EEC / AIMD 90/385/EEC EC certificate that remains valid under MDR Article 120
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The CE marking substitutes the conformity marking used in BiH; it does not remove the obligation to enter the device in the Register of medical devices kept by the Agency (Zakon 58/08, Član 108. stav (2); Pravilnik 71/12, Član 6. stav (2)).
Under Zakon 58/08 Član 108. stav (2) (restated in Pravilnik 71/12 Član 6. stav (2)) it is prohibited to market devices that are not entered in the Register kept by the Agency. Pravilnik 4/10 Član 75. was repealed by Pravilnik 71/12 Član 18.

Original (bs): as quoted. Translation: 'By way of exception from paragraph (2) of this Article, a manufacturer of a medical device whose conformity with the general and special requirements is determined by a conformity-assessment body recognised in the EU must mark the medical device with the CE marking, which is recognised in BiH.' The same rule is repeated in the implementing Ordinance (Pravilnik, Član 38. stav (3)), which adds that the CE mark or certificate of conformity implies conformity with the requirements and directives of the European Union. Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Bosnia and HerzegovinaEU conformity assessment

Prior approval / evidence record

Legacy MDD/AIMD EC certificates remain valid until 31 December 2027 or 2028 under MDR Article 120

reliance.legacy-mdd-aimd-ec-certificate-transition-deadlines

Fact-level verified

Statement: An EC certificate issued by an authorised body under Directives 90/385/EEC or 93/42/EEC from 25 May 2017, which was valid on 26 May 2021 and has not subsequently been withdrawn, remains in force beyond the end date printed on the certificate until 31 December 2027 for class III devices, implantable class IIb devices and AIMD devices, and until 31 December 2028 for the remaining class IIb devices, class IIa devices and class I devices placed on the market sterile or with a measuring function. The Agency accepts such certificates only where the manufacturer holds a signed MDR Annex VII written agreement with a notified body and confirms no significant change in design or intended purpose and no unacceptable risk.
Source Approval: Legacy EU EC certificate under MDD 93/42/EEC or AIMD 90/385/EEC extended by MDR (EU) 2017/745 Article 120
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The Agency requires, together with the EC certificate, a notified-body document confirming the MDR Annex VII application and a manufacturer's document confirming no significant change in design or intended purpose and no unacceptable risk.
MDR Article 120(3e) conditions include a quality management system compliant with MDR Article 10(9) from 26 May 2024.
Any significant change in design or intended purpose requires a fresh conformity assessment and a new declaration of conformity.

Original (bs): as quoted. Translation: 'If an EC certificate was issued by an authorised body in accordance with Directives 90/385/EEC and 93/42/EEC from 25 May 2017 and was valid on 26 May 2021 (the start of application of the EU MDR Regulation) and has not subsequently been withdrawn, it remains in force after the end of the period stated on the certificate, up to the following dates: (a) 31 December 2027 — for class III devices, implantable class IIb devices ... and AIMD devices; (b) 31 December 2028 — for class IIb devices not covered by point (a), class IIa devices and class I devices placed on the market in a sterile state or with a measuring function.' The guidance cites Article 120 of Regulation (EU) 2017/745 and Pravilnik Član 68.

Bosnia and HerzegovinaUS 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: Not recognised by Law čl. 102 or by the Agency's Instruction; useful only as supporting technical documentation.

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

Bosnia and HerzegovinaEU conformity assessment

Prior approval / evidence record

EU MDR (Regulation (EU) 2017/745) notified-body certificate

Authority: EU MDR (Regulation (EU) 2017/745) notified-body certificate
Accepted: Yes
Benefit: The Agency's Instruction is expressly framed as the response to the EU's transition from the MDD/AIMD to the MDR and cites MDR Article 120, so an MDR certificate is recognised on the same basis as an EC certificate. Bosnia and Herzegovina is not an EU member and the MDR is not directly applicable; the certificate enters the national procedure as a conformity input.

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

Bosnia and HerzegovinaEU conformity assessment

Prior approval / evidence record

In vitro diagnostic devices: EC certificate required except List D, with declaration of conformity

reliance.ivd-ec-certificate-required-except-list-d

Fact-level verified

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 certificate, EC certificate) — except for in vitro diagnostic devices on List D — together with the manufacturer's declaration of conformity against the European directive stating the list to which the device belongs. Class I (other) non-IVD devices are likewise exempt from the EC-certificate limb.
Source Approval: EU in vitro diagnostic certificate (CE marking certificate / EC certificate) under the EU IVD directives or IVDR
Edge Type: Abridged Or Recognition Route
Market Access Strength: facilitated
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

List D in vitro diagnostic devices are exempt from the EC-certificate limb of Član 69. stav (1) tačka c), but the manufacturer's declaration of conformity under tačka d) is still required.
The device must still be entered in the Register of medical devices kept by the Agency.

Original (bs): as quoted. Translation: '(c) a certificate of conformity of the in vitro medical device with the directives and regulations of the European Union (CE marking certificate, EC certificate) or a certificate of conformity of the medical device, original or certified copy in the country of origin, except for in vitro medical devices on List D; (d) a manufacturer's declaration of conformity with the European directive for in vitro medical devices, stating exactly the list to which the device belongs (Declaration of conformity), original or certified copy in the country of origin'. Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Bosnia and HerzegovinaEU conformity assessment

Prior approval / evidence record

Declaration of conformity must be issued against MDR after the 26 May 2021 transition

reliance.mdr-declaration-of-conformity-required-after-mdd-transition

Fact-level verified

Statement: Since 26 May 2021 a manufacturer's declaration of conformity issued against Directive 93/42/EEC can no longer be regarded as a valid document for a Class I risk device and will not be accepted; a declaration of conformity complying with Regulation (EU) 2017/745 must be submitted to the Agency for applications filed after that date. Any significant change in the design or intended purpose of the device requires a fresh conformity assessment and consequently a new declaration of conformity.
Source Approval: EU MDR (EU) 2017/745 declaration of conformity; the legacy MDD 93/42/EEC declaration is no longer accepted
Edge Type: Origin Country Evidence
Market Access Strength: Evidence Only
Regulatory Layer: Premarket Review
Local Application Required: Yes
Target Decision Retained: Yes

Conditions

The declaration of conformity is submitted as an original or a certified copy legalised in the country of origin (Pravilnik, Član 68. stav (1) tačka d)).
For devices moving class under the MDR, the guidance requires a notification-body document confirming the MDR Annex VII application plus the manufacturer's statement of no significant change and no unacceptable risk.
The guidance states it applies to applications not yet taken into processing.

Original (bs): as quoted. Translation: 'After 26 May 2021, a manufacturer's declaration of conformity with the requirements of Directive 93/42/EEC cannot be considered a valid document, i.e. it will not be accepted. In relation to the said medical devices, for applications submitted to the Agency after 26 May 2021, a manufacturer's declaration of conformity in accordance with the requirements of Regulation (EU) 2017/745 must be submitted.'

Special access & derogation

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

Compare countries

Devices for clinical investigation and custom-made devices are exempt from marking

special-access.marking-exemptions-for-clinical-trial-and-custom-made-devices

Fact-level verified

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.

Original (bs): as quoted. Translation: 'It is not necessary to mark medical devices which are: a) intended for clinical investigation; b) made to order for an individual patient or user.' This is a derogation from the conformity marking requirement, not from registration; the provisions of the Ordinance repeat it (Član 39). Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Submission communications & appeal

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

Compare countries

No appeal against the registration certificate or the classification decision; administrative dispute only

appeal.no-appeal-against-registration-certificate-administrative-dispute-only

Fact-level verified

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 to the Agency's conclusion (zaključak) on the categorisation of a medical device (Član 73. stav (3)). The Agency also issues expert opinions and answers to queries on request, with a limited validity of one year from the date of issue (Član 74). Separately, under Zakon 58/08 Član 118. stav (2) the Agency's decision refusing registration of a clinical investigation is final in the administrative procedure, with no appeal but an administrative dispute before the competent court.

Original (bs): as quoted. Translation: 'No appeal is permitted against this certificate, but an administrative dispute may be initiated. ... Article 73. (3) The Agency issues a decision on classification against which no appeal is permitted, but an administrative dispute may be initiated. Article 74. The Agency issues, on request, expert opinions and answers to queries which have a limited period of one year from the day of issue.'

UDI, listing & traceability

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

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Medical device must be entered in the Agency's Register before it may be placed on the market (state level, ALMBIH)

traceability.device-listing-in-agency-register-before-placement

Fact-level verified

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 Products and Medical Devices of Bosnia and Herzegovina (ALMBIH). Entry in the Register is an administrative procedure carried out by the Agency for the purpose of recording the devices in circulation in BiH and for the protection of public health, and it is the entry itself that confers on the applicant the right to place the device on the market of Bosnia and Herzegovina.

Conditions

The application for entry is filed by a manufacturer of medical devices established in BiH, or by a legal person that represents a foreign manufacturer and has its seat in BiH (Pravilnik 4/10, Član 65. stav (5)).
Marketing medical devices that are not entered in the Register kept by the Agency is prohibited (Zakon 58/08, Član 108. stav (2)).
The register of devices is separate from the register of manufacturers and wholesale distributors, which is also kept by the Agency (Zakon 58/08, Član 112. stav (1)).
Pravilnik 4/10 remains in force except for Član 29–33 and Član 75–84, which were repealed by Pravilnik 71/12, Član 18; the articles cited here are outside the repealed range.

Zakon o lijekovima i medicinskim sredstvima (Službeni glasnik BiH, br. 58/08) — Poglavlje IV: Medicinska sredstva (Član 96–123)

State-level instrument (Bosnia and Herzegovina), adopted by the Minister of Civil Affairs under the state Law 58/08 and administered by the state Agency ALMBIH. Source language is Bosnian, already in standard Latin orthography. The ordinance was adopted on 10 December 2009 and enters into force eight days after publication in Službeni glasnik BiH 4/10; the exact publication date was not read, so no effectiveFrom is asserted.

Republika Srpska entity law requires a separate entity register of medical devices in circulation in the entity

traceability.entity-level-device-register-republika-srpska

Fact-level verified

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 manufacturers and of legal persons carrying on wholesale trade in medical devices, and a register of the medical devices that are in circulation in the Republika Srpska. Circulation of medical devices that are not entered in that entity register is prohibited, and a retail seller may handle a medical device only if it is entered in the Register of medical devices for the territory of the Republika Srpska with the entity Agency.

Conditions

This is an ENTITY-level instrument of the Republika Srpska, adopted by the Narodna skupština Republike Srpske and published in Službeni glasnik Republike Srpske 118/21 of 28 December 2021; it is not a state-level instrument.
Under Član 137 the entity Law enters into force six months after publication, i.e. on 28 June 2022.
The entity law also requires a wholesale distributor to employ a responsible person with a degree in medicine who is charged with materiovigilance (Član 109. stav (3)) — the entity analogue of the state-level duty in Zakon 58/08, Član 109. tačka (c).
The entity law does not repeal or amend the state Law 58/08; its Član 136 repeals only the earlier Republika Srpska Law on Medicines (Sl. glasnik RS, br. 19/01, 113/05, 34/08).

Effective from 2022-06-28

Entity-level instrument (Republika Srpska). Source text is the Cyrillic-script official text published as a .docx attachment by the Narodna skupština Republike Srpske on the cited page; the page states the gazette reference as Službeni glasnik 118/21 and the date as 04.01.2022 (adoption 20 October 2021, per the instrument's signature block). The same page's register entry (Elektonski registar propisa Republike Srpske, record id 9179) carries the document behind a subscription, and the online gazette PDF is likewise paywalled, so both the Republic of Srpska Official Gazette PDF and the e-RP record were unreachable as full text; the Assembly's own published attachment was used instead. This fact records what the entity instrument says; it does not adjudicate the coexistence of the entity register with the state register, which is noted in unresolved.D18.

Register of manufacturers and wholesale distributors of medical devices, with a pre-commencement notification duty (state level, ALMBIH)

traceability.manufacturer-and-wholesaler-establishment-register

Fact-level verified

At state level the Agency keeps a register of manufacturers and of legal persons carrying on wholesale trade in medical devices, as well as the register of medical devices in circulation in BiH. A legal person that wholesales medical devices must, before it begins wholesaling, notify its activity to the Agency; the Agency considers the notification and keeps the register of legal persons carrying on wholesale trade in medical devices.

Conditions

The register of establishments and the register of devices are distinct registers kept by the same Agency (Zakon 58/08, Član 112. stav (1)).
The content and availability of both registers is prescribed by the Agency's Stručno vijeće on the proposal of the Director (Zakon 58/08, Član 112. stav (2)).

Effective from 2008-07-29

State-level primary legislation. The PDF published by ALMBIH carries the gazette text in the legacy YUSCII-derived encoding used by Službeni glasnik BiH (š→{, ž→}, č→~, ć→}, đ→|); the excerpt is transcribed into standard Latin orthography (č/ć/š/ž/đ) without changing any wording. Effective date from Član 142: the Law enters into force on the eighth day after publication in Službeni glasnik BiH; the gazette issue is dated 21 July 2008.

Wholesale records must permit serial-number-level tracking and be available to Agency inspectors (state level)

traceability.records-must-allow-serial-number-tracking

Fact-level verified

At state level the records kept by a wholesale distributor of medical devices must be clear and available to the inspectors of the Agency, and must enable traceability of the medical product, that is a simple verification of the origin of the medical product and of the destination to which it was delivered, by systematic tracking of serial numbers. Wholesale distributors must keep records of the implementation of their written distribution procedures.

Conditions

The duty is placed on the veleprometnik (wholesale distributor).
Where the records are kept electronically, protection against unauthorised access to the database and logging of every entry or review, with the identity of the person who performed it, must be secured.

Effective from 2018-11-03

State-level ordinance of the state Agency ALMBIH (Službeni glasnik BiH 75/18, in force 3 November 2018). Bosnian source text in standard Latin orthography. This is a record-and-traceability duty at batch/serial level; it is not a unique-device-identification (UDI) requirement — see unresolved.D18.

The Agency publishes the device Register and a medical-device database (state level, ALMBIH)

traceability.register-publication-and-device-database

Fact-level verified

At state level the Agency informs the professional public about the medical devices entered in the Register by publishing them in the official gazettes of BiH, the Federation of BiH, Republika Srpska and Brčko District at least once every three months, by publishing the Register of Medical Devices of BiH — which is how the availability of the register to the professional public is secured — and by publishing them in a medical-devices database.

Conditions

Pravilnik 4/10, Član 85. was not repealed by Pravilnik 71/12, whose Član 18 repealed only Član 29–33 and Član 75–84.

State-level implementing ordinance, Bosnian source text in standard Latin orthography. Član 85. is headed "(Oglašavanje)" and its stav (1) cross-refers advertising to the advertising ordinance; stav (2) is the register-publication duty quoted here.

Wholesale distribution records must ensure device traceability, kept 5 years (10 for implantables) (state level)

traceability.wholesaler-distribution-records-must-ensure-traceability

Fact-level verified

At state level a wholesale distributor of medical devices must cooperate with the manufacturer or with the authorised representative in BiH in order to achieve adequate traceability of the medical device, and must ensure the traceability of medical devices in the sense of the supplier from whom they were acquired and the customer to whom they were distributed. The documentation must be kept for at least 5 years, except for implantable medical devices, for which the retention period is 10 years.

Conditions

The duty is placed on the veleprometnik (wholesale distributor), not on the manufacturer; the manufacturer or its authorised representative in BiH is the counterparty with whom the distributor must cooperate.
Personal data in those records must be erased or anonymised as soon as their retention is no longer necessary for the purpose of distribution.

Effective from 2018-11-03

Pravilnik o proizvodnji i prometu na veliko medicinskih sredstava (Službeni glasnik BiH, br. 71/12)

State-level ordinance adopted by the Stručno vijeće of the state Agency ALMBIH, published in Službeni glasnik BiH 75/18 of 26 October 2018; Član 38 provides that it enters into force on the eighth day after publication. Bosnian source text in standard Latin orthography. The supporting source is the earlier state ordinance on manufacture and wholesale of medical devices, whose Član 7. stav (1) tačka (g) imposes the corresponding wholesale record-keeping duty by type, batch, quantity and class, enabling the competent authority's recording of medical devices in line with good distribution/wholesale practice.

Vigilance & incident reporting

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

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Manufacturers, distributors and health institutions must report adverse effects to the Agency

vigilance.manufacturers-distributors-and-health-institutions-must-report

Fact-level verified

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 conditions prescribed by the Ordinance on Medical Devices and the Act.

Original (bs): as quoted. Translation: '(10) Manufacturers, distributors and health institutions are obliged to report to the Agency every observed undesirable or harmful effect of medical devices in accordance with the conditions prescribed by this Ordinance and the Act.' The Act states the same reporting duty for wholesale distributors through the materiovigilance responsible person (Član 109. tačka c)).

Materiovigilance applies the Act's pharmacovigilance provisions to medical devices

vigilance.materiovigilance-follows-pharmacovigilance-provisions

Fact-level verified

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 reporting undesirable occurrences during the use of medical devices, the manner of responding to them, the obligations of medical staff and suppliers, and the organisation of the system for monitoring undesirable occurrences are prescribed by the Expert Council on the proposal of the Director of the Agency.

Conditions

The Ordinance adds that adverse effects of medical devices are regulated by the Ordinance on the manner of collecting and monitoring adverse effects of medicinal products and medical devices (Pravilnik, Član 86. stav (2)).

Original (bs): as quoted. Translation: 'Article 121 (Materiovigilance) (1) The provisions of Article 72(1) of this Act relating to pharmacovigilance apply correspondingly to medical devices, that is to the materiovigilance procedure. (2) The manner of and procedure for notification of undesirable occurrences during the use of medical devices, the manner of responding to them, the obligations of medical staff and suppliers, and the manner of organising the system for monitoring undesirable occurrences in the use of medical devices and responding to them, that is the materiovigilance system, are prescribed by the Expert Council on the proposal of the Director of the Agency.' Source bytes are the official gazette text as published in the legacy YUSCII-derived encoding used by „Službeni glasnik BiH“; the excerpt is normalised to standard Latin orthography (č/ć/š/ž/đ) without changing any wording.

Related structured datasets

Classification systems · 2 records

Open Bosnian and Herzegovinian in vitro diagnostic lists A, B, C and D →

bosnia-and-herzegovina:ivd

Jurisdiction Id

bosnia-and-herzegovina

Domains

Name

Bosnian and Herzegovinian in vitro diagnostic lists A, B, C and D

Description

In vitro diagnostic medical devices are classified on a separate, legacy axis. Čl. 99(4) of the Law divides them into devices used only by professional staff, which are themselves split into list A and list B, devices for self-diagnosis, and all other in vitro diagnostic devices; čl. 4(4) of the Pravilnik formalises those four as lista A, lista B, lista C (self-testing) and lista D (all others), and čl. 5(3) sets out the contents of each list — list A covering ABO, rhesus and the antibody panel together with reagents for detecting and quantifying HIV 1 and 2, HTLV 1 and 2 and hepatitis B, C and D; list B covering anti-Duffy and anti-Kidd, irregular anti-erythrocyte antibodies, rubella and toxoplasmosis, phenylketonuria, cytomegalovirus and chlamydia, HLA tissue groups, PSA and trisomy 21 risk; list C covering self-testing devices and their accessories; and list D covering everything else. List A is the highest-risk list and list D the residual one. These lists are recorded in the single state Register of medical devices administered by ALMBIH, and the same čl. 65(8) entry right applies.

Classes

Id
list-d
Label
List D — all other in vitro diagnostic devices
Normalized Risk Level
low
Id
list-c
Label
List C — devices for self-diagnosis
Normalized Risk Level
medium
Id
list-b
Label
List B — professional-use devices named in the list
Normalized Risk Level
high
Id
list-a
Label
List A — professional-use devices named in the list
Normalized Risk Level
highest

Regulator

ALMBiH

Official Domains

almbih.gov.ba

Source Status

official-source-verified

Reference Sources

Title
Zakon o lijekovima i medicinskim sredstvima, Službeni glasnik BiH br. 58/08, čl. 99(4) i 101
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/zakon_o_lijekovima_bih_bo.pdf
Reviewed On
2026-09-16
Supports
Čl. 99(4) creates the in vitro axis of the Law — professional-use devices split into list A and list B, devices for self-diagnosis, and all other in vitro diagnostic devices — and čl. 101 subjects the conformity-assessment route to the classification.
Title
Dopuna i izmjena upisa u Registar medicinskih sredstava — spisak dokumentacije, ALMBIH, 30.10.2025
Url
https://almbih.gov.ba/wp-content/uploads/2025/10/Dopuna-i-izmjena-upisa-u-Registar-medicinskih-sredstava-spisak-dokumentacije-30.10.2025.pdf
Reviewed On
2026-09-16
Supports
The Agency's current documentation list for entry and for amendment of entry in the Register, which requires proof of payment of a 20 KM administrative fee on every request form and cites čl. 71 of the Pravilnik o medicinskim sredstvima (Službeni glasnik BiH 4/10) as the basis for amendments.

Source Title

Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10 od 19.01.2010, čl. 4(4) i 5(1)-(3)

Source Url

https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_ms_bos.pdf

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Open Bosnian and Herzegovinian classes I, II-a, II-b and III →

bosnia-and-herzegovina:medical-device

Jurisdiction Id

bosnia-and-herzegovina

Domains

medical-device

Name

Bosnian and Herzegovinian classes I, II-a, II-b and III

Description

The class axis of the state Law on Medicines and Medical Devices, not the EU MDR. Čl. 99(1) of the Zakon o lijekovima i medicinskim sredstvima grades medical devices into Class I (low), Class II-a (higher), Class II-b (high) and Class III (highest) risk, and čl. 99(2), (3), (5) and (6) add nature, duration of use, dispensing channel and combination-product axes; čl. 101 makes the conformity-assessment route depend on that class — self-assessment with a manufacturer's declaration for Class I, except devices with a measuring function and sterile products, which are handled as Class II or III, and authorised institutions for Class II-a, II-b and III, with the Agency's Commission for Medical Devices taking over where no authorised institution exists. Čl. 102(3) requires a manufacturer whose conformity is determined by a conformity-assessment body recognised in the EU to affix the CE marking recognised in BiH, and the Agency's Instruction of 6 February 2025 sets out how an EC certificate issued under Directives 90/385/EEC and 93/42/EEC is recognised. Recognising that certificate is an administrative act of ALMBIH, not an application of Regulation (EU) 2017/745: the device is still entered in the Agency's register, which by čl. 65(8) of the Pravilnik is what confers the right to place it on the market of Bosnia and Herzegovina. Authority for the register sits with the STATE agency, not with the entities: čl. 8(a) of the Law gives the Agency the register of medical devices 'za teritoriju BiH', čl. 108(2) forbids marketing any device not entered in that register, and the entities and Brčko District prescribe only the conditions on premises, equipment and personnel under čl. 104(2).

Classes

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

Regulator

ALMBiH

Official Domains

almbih.gov.ba

Source Status

official-source-verified

Reference Sources

Title
Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10 od 19.01.2010, čl. 4, 5, 28, 30, 65, 66, 70 i 71
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_ms_bos.pdf
Reviewed On
2026-09-16
Supports
Čl. 4(1) repeats the four classes of the Law; čl. 65(1) makes the Agency keep the register of medical devices in circulation in BiH; čl. 65(8) provides that entry in the Register confers the right to place the device on the market of Bosnia and Herzegovina; čl. 65(9) fixes the 90-day certificate; čl. 66(2)(a) requires the application form for the class concerned; čl. 28(4) gives the entity ministries four seats each and the Brčko District one on the Agency's Commission for Medical Devices; čl. 30(1)(c) and (2) confine the entity procedure to premises, equipment and personnel.
Title
Uputstvo o uslovima i načinu priznavanja sertifikata o usaglašenosti medicinskih sredstava (EC sertifikat) usljed prelaska EU direktiva (MDD/AIMD) na EU regulativu (MDR), ALMBIH, 06.02.2025
Url
https://almbih.gov.ba/wp-content/uploads/2025/02/Uputstvo-o-uslovima-i-nacinu-priznavanja-sertifikata-o-usaglasenosti-medicinskih-sredstava-EC-sertifikat-usljed-prelaska-EU-direktiva-MDD-AIMD-na-EU-regulativu-MDR.pdf
Reviewed On
2026-09-16
Supports
The Agency's own instruction, issued on the basis of čl. 100 and 101 of the Law (Službeni glasnik BiH 58/08) and čl. 68 of the Pravilnik o medicinskim sredstvima (Službeni glasnik BiH 04/10), recognising an EC certificate issued under Directives 90/385/EEC and 93/42/EEC that was valid on 26 May 2021 and not withdrawn, listing the documentation to be supplied, and requiring under čl. 70 of the Pravilnik that expired documentation be renewed. This is the instrument that shows the CE certificate entering the national procedure as an input rather than the MDR governing the device.

Source Title

Zakon o lijekovima i medicinskim sredstvima, Službeni glasnik BiH br. 58/08 od 21.07.2008, čl. 8, 99, 101, 102, 104 i 108

Source Url

https://almbih.gov.ba/wp-content/uploads/2023/09/zakon_o_lijekovima_bih_bo.pdf

Verified On

2026-09-16

Source Supports

class-axis
classification-rules

Registration pathways, prior approvals and planning · 1 record

Open Bosnia and Herzegovina registration →

Country

Bosnia and Herzegovina

Jurisdiction Id

bosnia-and-herzegovina

Country Code

Flag

🇧🇦

Regulator

Agencija za lijekove i medicinska sredstva Bosne i Hercegovine

Regulator Abbrev

ALMBiH

Region

europe

Tier

Risk Classification

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

Classes

Id
register-entry-class-i
Class Name
Class I — entry in the ALMBIH Register of medical devices
Risk Level
low
Pathway
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))
Official Timeline
Min
90
Max
90
Unit
days
Verification Status
official-verified
Official Source
Title
Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10 od 19.01.2010, čl. 65(5)-(9)
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_ms_bos.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
3
Max
7
Notes
Čl. 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 (čl. 65(9)).
Čl. 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 (čl. 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.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
register-entry-class-iia-iib-iii
Class Name
Classes II-a, II-b and III — entry in the ALMBIH Register of medical devices
Risk Level
high
Pathway
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)
Official Timeline
Min
90
Max
90
Unit
days
Verification Status
official-verified
Official Source
Title
Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10 od 19.01.2010, čl. 65(5)-(9)
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_ms_bos.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
5
Max
10
Notes
The same čl. 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 čl. 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 čl. 101(2)(a), so they fall on this route even though their nominal class is I.
Clinical Trial Required
No
Local Testing Required
No
Gmp Required
No
Id
clinical-investigation-tacit-approval
Class Name
Clinical investigation of a medical device — tacit approval
Risk Level
medium
Pathway
Notification of a clinical investigation to the Agency by the manufacturer or the importer of the medical device (Law čl. 120(1))
Official Timeline
Min
30
Max
30
Unit
days
Verification Status
official-verified
Official Source
Title
Zakon o lijekovima i medicinskim sredstvima, Službeni glasnik BiH br. 58/08 od 21.07.2008, čl. 118
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/zakon_o_lijekovima_bih_bo.pdf
Accessed Date
2026-09-16
Realistic Timeline
Min
2
Max
4
Notes
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.
Čl. 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.
Čl. 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 čl. 21(a) and (b)).
Clinical Trial Required
Yes
Local Testing Required
No
Gmp Required
No

Prior Approvals

Authority
EU CE marking — EC certificate issued under Directives 90/385/EEC or 93/42/EEC
Accepted
Yes
Benefit
Law čl. 102(3) requires a manufacturer whose conformity is determined by a conformity-assessment body recognised in the EU to affix the CE marking recognised in BiH, and the Agency's Instruction of 6 February 2025 sets out the conditions and documentation for recognising an EC certificate issued under Directive 90/385/EEC or 93/42/EEC that was valid on 26 May 2021 and not withdrawn, including the MDR Annex VII application-and-contract evidence. Recognition is an administrative act of the Agency under čl. 100 and 101 of the Law and čl. 68 of the Pravilnik; it does not replace entry in the Register, which under Pravilnik čl. 65(8) is what confers the right to place the device on the market.
Authority
EU MDR (Regulation (EU) 2017/745) notified-body certificate
Accepted
Yes
Benefit
The Agency's Instruction is expressly framed as the response to the EU's transition from the MDD/AIMD to the MDR and cites MDR Article 120, so an MDR certificate is recognised on the same basis as an EC certificate. Bosnia and Herzegovina is not an EU member and the MDR is not directly applicable; the certificate enters the national procedure as a conformity input.
Authority
US FDA 510(k) clearance or PMA approval
Accepted
No
Benefit
Not recognised by Law čl. 102 or by the Agency's Instruction; useful only as supporting technical documentation.

Key Requirements

File the application for entry in the Register through a manufacturer seated in BiH or a legal person representing the foreign manufacturer and seated in BiH (Pravilnik čl. 65(5)).
Hold a manufacturer's authorisation or a representation contract registered with the state Ministry of Foreign Trade and Economic Relations (Pravilnik čl. 65(6)).
Supply evidence of product-liability insurance for possible damage to the user that is valid on the territory of Bosnia and Herzegovina (Pravilnik čl. 65(7)).
Submit the application form for the class concerned (Pravilnik čl. 66(2)(a)) together with the complete documentation prescribed for the certificate of entry, and expect the clock only to run on a formally complete application (Pravilnik čl. 66(1) and (3)).
Pay the 20 KM administrative fee stamped on each request form and the tariff fee under Pravilnik 70/09, both evidenced by payment slips (ALMBIH documentation list, 30.10.2025).
Renew expiring certificates and other documents within 30 days (Pravilnik čl. 70(3)); if they are not renewed and not delivered in time, the Agency deletes the device from the Register by conclusion (Pravilnik čl. 70(5)).
Notify the Agency in writing of every change, renewal or supplement to the certificate or to the submitted documentation during its period of validity (Pravilnik čl. 71(1)).
Where the device is manufactured abroad, the duties of the manufacturer are assumed by the supplier or importer in BiH (Law čl. 106(4)).
If the device is manufactured or its activity is carried out in the Federation of BiH or Republika Srpska, also satisfy the entity conditions on premises, equipment and personnel prescribed under Law čl. 104(2) and obtain the entity decision, which is a precondition for the Agency's certificate of entry in the register of manufacturers (Pravilnik čl. 30(1)(c) and (2)).

Local Rep Required

Yes

Local Rep Name

Legal person representing the foreign manufacturer with a seat in Bosnia and Herzegovina, holding a manufacturer's authorisation or a representation contract registered with the Ministry of Foreign Trade and Economic Relations of BiH (Pravilnik čl. 65(5) and (6))

Mdsap Accepted

Mdsap Benefit

Not recognised. Quality-system evidence enters through the conformity route of Law čl. 101 and, for manufacturers seated in BiH, through the Agency's GMP inspector under Pravilnik čl. 30(1)(b).

Registration Validity

The certificate of entry is issued for five years from its date of issue (Pravilnik čl. 70(2)), and the entry confers the right to place the device on the market until the certificate expires (čl. 70(1)). Expiring certificates and other documents must be renewed within 30 days (čl. 70(3)); a certificate showing only an issue date must be replaced within five years of that date (čl. 70(4)); failure to renew leads to deletion from the Register by conclusion (čl. 70(5)).

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10 od 19.01.2010, čl. 65(5)-(9)
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_ms_bos.pdf
Accessed Date
2026-09-16
Title
Zakon o lijekovima i medicinskim sredstvima, Službeni glasnik BiH br. 58/08 od 21.07.2008, čl. 118
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/zakon_o_lijekovima_bih_bo.pdf
Accessed Date
2026-09-16
Title
Pravilnik o medicinskim sredstvima, Službeni glasnik BiH br. 4/10, čl. 70 i 71
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_ms_bos.pdf
Accessed Date
2026-09-16
Title
ALMBIH — Dopuna i izmjena upisa u Registar medicinskih sredstava, spisak dokumentacije, 30.10.2025
Url
https://almbih.gov.ba/wp-content/uploads/2025/10/Dopuna-i-izmjena-upisa-u-Registar-medicinskih-sredstava-spisak-dokumentacije-30.10.2025.pdf
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 ALMBiH. Appoint a Legal person representing the foreign manufacturer with a seat in Bosnia and Herzegovina, holding a manufacturer's authorisation or a representation contract registered with the Ministry of Foreign Trade and Economic Relations of BiH (Pravilnik čl. 65(5) and (6)).
Duration
1-3 months
Icon
📋
Step
2
Title
Application Submission
Description
Submit complete registration dossier to ALMBiH including device description, risk analysis, and testing reports.
Duration
1-2 weeks
Icon
📤
Step
3
Title
Administrative Review
Description
ALMBiH 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. ALMBiH may issue questions.
Duration
90 days
Icon
⚙️
Step
5
Title
Registration Approval
Description
Upon successful review, ALMBiH issues Bosnia and Herzegovina market authorization certificate.
Duration
1-2 weeks
Icon
✅

Government fee schedules · 1 record

Open Bosnia and Herzegovina fees →

Jurisdiction Id

bosnia-and-herzegovina

Country

Bosnia and Herzegovina

Country Code

Authority

ALMBiH

Low Risk Local

Min: 100
Max: 200
Currency: BAM
Per Product: Yes

High Risk Local

Min: 300
Max: 800
Currency: BAM
Per Product: Yes

Details

Id
entry-class-i-up-to-25-products
Item
Entry in the Register of medical devices, Class I — up to 25 products by protected or generic name in the application
Currency
BAM
Amount Local
200
Amount Local Formatted
BAM 200
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(a)(1). The tiers are 200 KM up to 25 products, 150 KM up to 100 and 100 KM over 100.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-class-i-over-100-products
Item
Entry in the Register of medical devices, Class I — over 100 products by protected or generic name in the application
Currency
BAM
Amount Local
100
Amount Local Formatted
BAM 100
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(a)(3). This is the floor of the Class I band.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-class-iia-iib-up-to-25-products
Item
Entry in the Register of medical devices, Classes IIa and IIb — up to 25 products by protected or generic name in the application
Currency
BAM
Amount Local
400
Amount Local Formatted
BAM 400
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(b)(1). Classes IIa and IIb share one tariff line: 400 KM up to 25 products, 350 KM up to 100 and 300 KM over 100.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-class-iia-iib-over-100-products
Item
Entry in the Register of medical devices, Classes IIa and IIb — over 100 products by protected or generic name in the application
Currency
BAM
Amount Local
300
Amount Local Formatted
BAM 300
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(b)(3). This is the floor of the IIa/IIb band.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-class-iii-up-to-15-products
Item
Entry in the Register of medical devices, Class III — up to 15 products by protected or generic name in the application
Currency
BAM
Amount Local
700
Amount Local Formatted
BAM 700
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(c)(1). Over 15 products the line drops to 500 KM.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-class-iii-over-15-products
Item
Entry in the Register of medical devices, Class III — over 15 products by protected or generic name in the application
Currency
BAM
Amount Local
500
Amount Local Formatted
BAM 500
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(c)(2).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-in-vitro-up-to-25-products
Item
Entry in the Register of medical devices, in vitro diagnostic devices — up to 25 products by protected or generic name in the application
Currency
BAM
Amount Local
200
Amount Local Formatted
BAM 200
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(d)(1). The in vitro line is charged at the Class I rate: 200 KM up to 25, 150 KM up to 100 and 100 KM over 100, notwithstanding that in vitro lists A and B are the highest-risk lists on the classification axis.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-active-implantable-up-to-10-products
Item
Entry in the Register of medical devices, active implantable devices — up to 10 products by protected or generic name in the application
Currency
BAM
Amount Local
800
Amount Local Formatted
BAM 800
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(e)(1). Active implantable devices have their own line: 800 KM up to 10 products, 600 KM up to 25 and 500 KM over 25.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entry-active-implantable-over-25-products
Item
Entry in the Register of medical devices, active implantable devices — over 25 products by protected or generic name in the application
Currency
BAM
Amount Local
500
Amount Local Formatted
BAM 500
Frequency
Per individual product in the application, tiered by the number of names
Notes
Pravilnik čl. 16(1)(e)(3). This is the ceiling of the active-implantable line.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
amendment-of-register-entry
Item
Amendment of an entry in the Register of medical devices
Currency
BAM
Amount Local
200
Amount Local Formatted
BAM 200
Frequency
Per request
Notes
Pravilnik čl. 16(1)(g). Čl. 71(3) of the Pravilnik o medicinskim sredstvima lists the amendments that may be requested, including a change of the device's class.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
supplement-of-register-entry
Item
Supplement of an entry in the Register of medical devices
Currency
BAM
Amount Local
200
Amount Local Formatted
BAM 200
Frequency
Per request
Notes
Pravilnik čl. 16(1)(h).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
expert-opinion-on-medical-device
Item
Expert opinion relating to a medical device
Currency
BAM
Amount Local
100
Amount Local Formatted
BAM 100
Frequency
Per opinion
Notes
Pravilnik čl. 16(1)(i).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
certificate-of-conformity
Item
Issue of a certificate of conformity for a medical device
Currency
BAM
Amount Local
1000
Amount Local Formatted
BAM 1,000
Frequency
Per certificate
Notes
Pravilnik čl. 16(1)(j). This is the fee for the conformity certificate that čl. 102 of the Law makes the basis for affixing the conformity mark.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
classification-request
Item
Decision on a request to classify a medical device
Currency
BAM
Amount Local
200
Amount Local Formatted
BAM 200
Frequency
Per request
Notes
Pravilnik čl. 16(1)(k).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
clinical-investigation-authorisation
Item
Authorisation for a clinical investigation of a medical device
Currency
BAM
Amount Local
3000
Amount Local Formatted
BAM 3,000
Frequency
Per authorisation
Notes
Pravilnik čl. 21(a). The notification of a clinical investigation of an already-registered device is 1,000 KM under čl. 21(b), amendments and supplements to the authorisation 400 KM under čl. 21(c), minor administrative changes 200 KM under čl. 21(d) and the adverse-event report that forms part of a renewal dossier 300 KM under čl. 21(e).
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
entity-permit-existence-certificate
Item
Certificate of the existence and duration of an entity permit linked to an entry in the Register of medical devices
Currency
BAM
Amount Local
300
Amount Local Formatted
BAM 300
Frequency
Per certificate
Notes
Pravilnik čl. 20. The Agency charges for certifying the existence and duration of an entity permit held by a holder of a Register entry, which is direct evidence that the entity permits exist alongside the state Register entry rather than replacing it.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Source Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Source Effective Date
2009-07-16
Verified On
2026-09-16
Id
administrative-taksa-per-request
Item
Administrative fee stamped on each request form submitted to the Agency
Currency
BAM
Amount Local
20
Amount Local Formatted
BAM 20
Frequency
Per request form
Notes
Required as 'Dokaz o uplati 20 KM administrativne takse' on every request form in the Agency's documentation list of 30.10.2025, paid to the BiH Treasury. It is a separate charge from the Pravilnik 70/09 fees above.
Amount Status
exact-current
Verification Status
official-verified
Source Url
https://almbih.gov.ba/wp-content/uploads/2025/10/Dopuna-i-izmjena-upisa-u-Registar-medicinskih-sredstava-spisak-dokumentacije-30.10.2025.pdf
Source Title
ALMBIH — Dopuna i izmjena upisa u Registar medicinskih sredstava, spisak dokumentacije, 30.10.2025 (administrativna taksa upisana na svakom obrascu zahtjeva)
Verified On
2026-09-16

Notes

The tariff is graded by class and by the number of protected or generic names in one application: Class I and in vitro diagnostic devices 200 / 150 / 100 KM for up to 25, up to 100 and over 100 products; Classes IIa and IIb 400 / 350 / 300 KM; Class III 700 KM up to 15 products and 500 KM over 15; active implantable devices 800 / 600 / 500 KM.
Renewal of an entry (obnova upisa) is not published as a fixed amount: čl. 16(1)(f) sets it at 50% of the amount of the first entry in the Register, so it is deliberately not published here as an exact figure.
All amounts are expressed in KM without value added tax (Uvodni dio: 'Visina troškova je iskazana u KM bez uračunatog PDV').
The Pravilnik was adopted by the Council of Ministers at its 94th session held on 16 July 2009, on the proposal of the Agency's director, under čl. 112(3) and related provisions of the Zakon o lijekovima i medicinskim sredstvima (Službeni glasnik BiH 58/08), and čl. 24 makes it enter into force on the day of its adoption; it was published in Službeni glasnik BiH br. 70 of 7 September 2009.
The register-entry fee is charged 'za svaki pojedinačni proizvod iz zahtjeva prema broju zaštićenih ili generičkih naziva medicinskih sredstava', that is per individual product counted by the number of names in the application, not per application.
Advertising authorisations carry their own tariff under čl. 17: 1,000 KM to issue, 800 KM to renew and 500 KM to amend or supplement. Registration of a legal person in the register of manufacturers is charged under čl. 18, including 1,000 KM for the quality-system procedure and 500 KM for a good-manufacturing-practice certificate; entry in the register of wholesalers is charged under čl. 19.

Last Updated

2026-09-16

Verification Status

official-verified

Official Sources

Title
Pravilnik o vrsti, visini i načinu plaćanja troškova za obavljanje poslova Agencije za lijekove i medicinska sredstva Bosne i Hercegovine, Službeni glasnik BiH br. 70 od 07.09.2009, čl. 16-21 i 24
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf
Effective Date
2009-07-16
Accessed Date
2026-09-16
Title
ALMBIH — Dopuna i izmjena upisa u Registar medicinskih sredstava, spisak dokumentacije, 30.10.2025 (administrativna taksa upisana na svakom obrascu zahtjeva)
Url
https://almbih.gov.ba/wp-content/uploads/2025/10/Dopuna-i-izmjena-upisa-u-Registar-medicinskih-sredstava-spisak-dokumentacije-30.10.2025.pdf
Accessed Date
2026-09-16

Reviewed On

2026-09-16

Amount Status

exact-current

Range Available

Yes

Additional certifications and licences · 1 record

Open Bosnia and Herzegovina certifications →

Slug

bosnia-and-herzegovina

Market

Bosnia and Herzegovina

Confidence

low

Schemes

Id
bih-horizontal-product-conformity
Name
BiH technical requirements for products and conformity assessment
Category
Product Specific Conformity
Status
Included In Medical Registration
Object
Finished Device
Note
Čl. 101 of the Zakon o lijekovima i medicinskim sredstvima defines the conformity assessment of a medical device as the procedure establishing whether it meets the requirements of the Zakon o općoj sigurnosti proizvoda, the Zakon o tehničkim zahtjevima za proizvode i ocjenjivanje usklađenosti and the regulations adopted under them. The latter is the state horizontal framework law published by the Agencija za nadzor nad tržištem (ANNT); the instrument was retrieved as the Agency's own consolidated text. It is the umbrella under which the electrical-equipment and EMC ordinances below sit, and the device is documented to ALMBIH through it rather than certified a second time.
Source Urls
https://annt.gov.ba/Agencija/zakonodavstvo/Zakon_tehnicki_zahtjevi_za_proizvode_i_ocjenjivanje_uskladjenosti_bos.pdf
Source Binding
candidate
Id
annt-electrical-equipment-safety
Name
ANNT electrical-equipment safety ordinance
Category
Medical Electrical Safety
Status
Included In Medical Registration
Object
Finished Device
Note
Electrical equipment within the prescribed voltage limits placed on the BiH market must meet the ordinance adopted under the state framework law on technical requirements for products, published in its Bosnian edition by the market-surveillance Agency (ANNT). A medical device is not certified separately against it: čl. 101 of the Law on Medicines routes the device's conformity to that framework, and the device's electrical safety is part of the documentation assessed by ALMBIH through the recognised conformity documents. The ordinance was retrieved as the Agency's own file but not read article by article, so no source is bound to this row.
Source Binding
unresolved
Id
annt-emc
Name
ANNT electromagnetic-compatibility ordinance
Category
emc
Status
Included In Medical Registration
Object
Finished Device
Note
Electromagnetic compatibility for equipment supplied on the BiH market is governed by the ANNT ordinance adopted under the same framework law, retrieved as the Agency's own Bosnian edition. As with electrical safety, a medical device's EMC is part of the conformity documented to ALMBIH rather than a separate national certification, and the ordinance was not read article by article, so the binding is a candidate.
Source Urls
https://annt.gov.ba/Agencija/zakonodavstvo/Naredba_EMC_bos.pdf
Source Binding
candidate
Id
rak-radio-equipment
Name
RAK radio-equipment market access
Category
Radio Spectrum
Status
Mandatory If Feature
Object
Radio Equipment
Note
The Regulatorna agencija za komunikacije (RAK) is the state authority for radio spectrum and publishes its bylaws on its own site; its About page states the Agency's establishment and remit. Radio equipment placed on the BiH market must meet the RAK bylaws made under that remit, and the obligation attaches to a medical device only where the device contains a radio transmitter or receiver. RAK's pages are JavaScript-rendered, so the bylaw index was retrieved only as a shell and no instrument text could be read — this row is a pointer to the authority's own bylaw register, not a text binding, and is marked candidate accordingly.
Source Urls
https://www.rak.ba/hr/legal-bylaws
https://rak.ba/en/about
Source Binding
candidate
Id
rak-telecom-network-attachment
Name
RAK telecommunications network attachment
Category
Telecom Network Attachment
Status
Mandatory If Feature
Object
Telecom Terminal Equipment
Note
RAK is also the state regulator for telecommunications, and its published bylaw register is the only official pointer located for the rules on attaching terminal equipment to a public telecommunications network in BiH. The register itself did not render server-side, so no instrument governing network attachment was read and no article is cited; the row records that the authority exists and where its bylaws are published, and the gap is carried in unresolved.
Source Urls
https://www.rak.ba/hr/legal-bylaws
Source Binding
candidate
Id
fbih-legal-metrology
Name
Legal metrology — Federation of BiH verification certificate
Category
Legal Metrology
Status
Mandatory If Feature
Object
Measuring Instrument
Note
State-level competence sits with the Institut za mjeriteljstvo Bosne i Hercegovine (IMBIH), whose site could be retrieved only as an application shell, while the operative legal-metrology act for the Federation of BiH is the entity metrology law and its implementing body is the Zavod za mjeriteljstvo Federacije BiH, whose own ministry page states that it performs the professional and organisational tasks of metrology in the Federation, adopts technical regulations on the verification of measuring instruments and carries out testing and verification. The Federation law defines, verbatim, the 'potvrda o ispunjenju mjeriteljskih i drugih uvjeta' as the document issued by the Federation Metrology Institute for measuring instruments that are imported and subject to mandatory metrological supervision, without which the import may not be permitted. A medical device with a measuring function therefore engages the entity institute in addition to ALMBIH registration. The equivalent Republika Srpska instrument was not located; the Federation law page prints the gazette name but no gazette number, so none is asserted.
Source Urls
https://fmeri.gov.ba/ministarstvo/zavod-za-mjeriteljstvo-fbih
https://www.fbihvlada.gov.ba/bosanski/zakoni/2005/zakoni/1bos.htm
https://www.met.gov.ba/bs-latn-ba/about-us
Source Binding
candidate
Id
darns-ionizing-radiation
Name
DARNS ionizing-radiation and nuclear safety
Category
Ionizing Radiation
Status
Mandatory For Use Site
Object
Ionizing Radiation Equipment
Note
The Državna agencija za radijacijsku i nuklearnu sigurnost (DARNS) is the state authority for radiation and nuclear safety; its own competence page states that the Agency's competences are prescribed by čl. 8 of the Zakon o radijacijskoj i nuklearnoj sigurnosti u Bosni i Hercegovini, and it publishes the legislation it administers. A medical device containing a radiation source engages DARNS in addition to ALMBIH. The statute itself was not read, so the binding is a candidate.
Source Urls
https://www.darns.gov.ba/bs/ONama/NadleznostiBH
https://www.darns.gov.ba/bs/LegislationAndDocuments/Zakoni
Source Binding
reviewed
Id
fmoit-waste-and-batteries
Name
Federation of BiH waste and waste-battery rules
Category
Environmental And Batteries
Status
Mandatory If Feature
Object
Electrical And Electronic Equipment
Note
Waste management in the Federation of BiH is regulated by the entity ministry — the Federalno ministarstvo okoliša i turizma (FMoIT) publishes both the entity waste law and the rulebook on managing waste batteries and accumulators on its own site. These impose producer and importer duties on a person placing electrical or electronic equipment, including medical devices, on the entity market; they do not condition the device's market authorisation, which remains the ALMBIH register entry. The instruments were retrieved as the ministry's own documents but not read article by article, so the binding is a candidate.
Source Urls
https://fmoit.gov.ba/dokumenti/zakon-o-upravljanju-otpadom/
https://fmoit.gov.ba/dokument/pravilnik-o-upravljanju-otpadnim-baterijama-i-akumulatorima
Source Binding
candidate
Id
almbih-register-entry
Name
ALMBIH entry in the Register of medical devices
Category
Import Conformity
Status
Mandatory At Import
Object
Finished Device
Note
Entry in the Agency's Register is the market gate for the whole territory of Bosnia and Herzegovina. Čl. 65(5) of the Pravilnik requires the application to be filed by a manufacturer with a seat in BiH or by a legal person representing a foreign manufacturer and seated in BiH; čl. 65(6) requires the representative to hold a manufacturer's authorisation or a representation contract registered with the state Ministry of Foreign Trade and Economic Relations; čl. 65(7) requires evidence of product-liability insurance valid on the territory of BiH; čl. 65(8) makes the entry the act conferring the right to place the device on the market; čl. 65(9) requires the certificate of entry within 90 days of a complete application, with no appeal but with an administrative dispute available; and čl. 108(2) of the Law forbids marketing a device not entered in that register. The Agency's current documentation list was read in full.
Source Urls
https://almbih.gov.ba/wp-content/uploads/2025/10/Dopuna-i-izmjena-upisa-u-Registar-medicinskih-sredstava-spisak-dokumentacije-30.10.2025.pdf
https://almbih.gov.ba/wp-content/uploads/2025/02/Uputstvo-o-uslovima-i-nacinu-priznavanja-sertifikata-o-usaglasenosti-medicinskih-sredstava-EC-sertifikat-usljed-prelaska-EU-direktiva-MDD-AIMD-na-EU-regulativu-MDR.pdf
Source Binding
reviewed

Official Sources

Authority
Agencija za nadzor nad tržištem BiH (ANNT)
Topic
Zakon o tehničkim zahtjevima za proizvode i ocjenjivanje usklađenosti, Bosnian edition
Url
https://annt.gov.ba/Agencija/zakonodavstvo/Zakon_tehnicki_zahtjevi_za_proizvode_i_ocjenjivanje_uskladjenosti_bos.pdf
Authority
Agencija za nadzor nad tržištem BiH (ANNT)
Topic
naredba o električnoj opremi
Url
https://annt.gov.ba/Agencija/zakonodavstvo/naredba-o-elektricnoj-opremi-ba.pdf
Authority
Agencija za nadzor nad tržištem BiH (ANNT)
Topic
naredba o elektromagnetnoj kompatibilnosti
Url
https://annt.gov.ba/Agencija/zakonodavstvo/Naredba_EMC_bos.pdf
Authority
Regulatorna agencija za komunikacije BiH (RAK)
Topic
register of legal bylaws
Url
https://www.rak.ba/hr/legal-bylaws
Authority
Regulatorna agencija za komunikacije BiH (RAK)
Topic
about the Agency and its remit
Url
https://rak.ba/en/about
Authority
Federalno ministarstvo energije, rudarstva i industrije
Topic
Zavod za mjeriteljstvo Federacije BiH — remit page
Url
https://fmeri.gov.ba/ministarstvo/zavod-za-mjeriteljstvo-fbih
Authority
Vlada Federacije BiH
Topic
Zakon o mjeriteljstvu u Federaciji BiH (2005)
Url
https://www.fbihvlada.gov.ba/bosanski/zakoni/2005/zakoni/1bos.htm
Authority
Institut za mjeriteljstvo Bosne i Hercegovine (IMBIH)
Topic
about the Institute
Url
https://www.met.gov.ba/bs-latn-ba/about-us
Authority
Državna agencija za radijacijsku i nuklearnu sigurnost (DARNS)
Topic
competences under čl. 8 of the Law on Radiation and Nuclear Safety in BiH
Url
https://www.darns.gov.ba/bs/ONama/NadleznostiBH
Authority
Državna agencija za radijacijsku i nuklearnu sigurnost (DARNS)
Topic
legislation and documents — laws
Url
https://www.darns.gov.ba/bs/LegislationAndDocuments/Zakoni
Authority
Federalno ministarstvo okoliša i turizma (FMoIT)
Topic
zakon o upravljanju otpadom
Url
https://fmoit.gov.ba/dokumenti/zakon-o-upravljanju-otpadom/
Authority
Federalno ministarstvo okoliša i turizma (FMoIT)
Topic
pravilnik o upravljanju otpadnim baterijama i akumulatorima
Url
https://fmoit.gov.ba/dokument/pravilnik-o-upravljanju-otpadnim-baterijama-i-akumulatorima
Authority
ALMBIH
Topic
spisak dokumentacije za upis i izmjenu upisa u Registar medicinskih sredstava, 30.10.2025
Url
https://almbih.gov.ba/wp-content/uploads/2025/10/Dopuna-i-izmjena-upisa-u-Registar-medicinskih-sredstava-spisak-dokumentacije-30.10.2025.pdf
Authority
ALMBIH
Topic
Uputstvo o priznavanju EC sertifikata usljed prelaska EU direktiva (MDD/AIMD) na EU regulativu (MDR), 06.02.2025
Url
https://almbih.gov.ba/wp-content/uploads/2025/02/Uputstvo-o-uslovima-i-nacinu-priznavanja-sertifikata-o-usaglasenosti-medicinskih-sredstava-EC-sertifikat-usljed-prelaska-EU-direktiva-MDD-AIMD-na-EU-regulativu-MDR.pdf
Authority
ALMBIH
Topic
Zakon o lijekovima i medicinskim sredstvima, Službeni glasnik BiH 58/08
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/zakon_o_lijekovima_bih_bo.pdf
Authority
ALMBIH
Topic
Pravilnik o medicinskim sredstvima, Službeni glasnik BiH 4/10
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_ms_bos.pdf
Authority
ALMBIH
Topic
Pravilnik o vrsti, visini i načinu plaćanja troškova, Službeni glasnik BiH 70/09
Url
https://almbih.gov.ba/wp-content/uploads/2023/09/pravilnik_placanje_70_09_bos.pdf

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