Bosnia and Herzegovina medical device registration timeline

Source-linked clocks

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

3 pathways3 of 3 clocks verifiedvalidity 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)).MDSAP not acceptedreviewed 2026-09-16almbih.gov.ba

Class / pathway	Review clock	Planning total	With prior approval	Provenance
Class I — entry in the ALMBIH Register of medical devices(Application for entry in the Register of medical devices filed with the Agency by a manufacturer seated in BiH or by a legal person representing a foreign manufacturer and seated in BiH, with the manufacturer's own declaration of conformity (Law čl. 101(2)(a))) 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.	90 days	3-7 months	—	Verified
Classes II-a, II-b and III — entry in the ALMBIH Register of medical devices(Application for entry in the Register of medical devices after conformity has been determined by an authorised institution, or by the Agency's Commission for Medical Devices where no authorised institution exists (Law čl. 101(2)(b) and the closing paragraph of čl. 101)) The same čl. 65(9) clock of 90 days applies to Classes II-a, II-b and III; the Pravilnik fixes no separate period per class.	90 days	5-10 months	—	Verified
Clinical investigation of a medical device — tacit approval(Notification of a clinical investigation to the Agency by the manufacturer or the importer of the medical device (Law čl. 120(1))) Čl. 118(1) of the Law provides that if the applicant receives no negative response from the Agency within 30 days of receipt of the notification, the clinical investigation may begin — a tacit-approval clock, not an express approval.	30 days	2-4 months	—	Verified

Review clocks exclude applicant hold time · planning totals are estimates

Planning steps and estimates; these are not regulator deadlines.

Bosnia and Herzegovina Medical Device Registration Process

Step-by-step ALMBiH registration process. Total estimated timeline: 3-7 months.

Step 1: Pre-Submission Preparation

1-3 months

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)).

Step 2: Application Submission

1-2 weeks

Submit complete registration dossier to ALMBiH including device description, risk analysis, and testing reports.

Step 3: Administrative Review

2-4 weeks

ALMBiH reviews application for completeness. May request additional documents or clarifications.

Step 4: Technical Evaluation

90 days

In-depth technical assessment of device safety and performance. ALMBiH may issue questions.

Step 5: Registration Approval

1-2 weeks

Upon successful review, ALMBiH issues Bosnia and Herzegovina market authorization certificate.

Summary: The Bosnia and Herzegovina medical device registration process through Agencija za lijekove i medicinska sredstva Bosne i Hercegovine (ALMBiH) consists of 5 main steps: Pre-Submission Preparation → Application Submission → Administrative Review → Technical Evaluation → Registration Approval.

Prior approval recognition

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

EU MDR (Regulation (EU) 2017/745) notified-body certificateThe 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.

US FDA 510(k) clearance or PMA approvalNot 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)).

Primary regulator sources

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

Reviewed 2026-09-16. End-to-end totals remain planning estimates.

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Source-linked review clocks verified against ALMBiH publications · full review 2026-09-16 · row IDs are stable — cite as registration-timeline:bosnia-and-herzegovina:register-entry-class-i