Bosnia Medical Device Registration and ALMBIH Regulatory Consulting Support
Enter Bosnia and Herzegovina an EU aligned Western Balkans market on the path to EU accession, where your CE mark is the foundation for fast access. NexorTest delivers end-to-end ALMBIH registration: Class I/IIa/IIb/III certification, CE marking reliance, Bosnia Authorized Representative (local importer) services, national-register filing and Bosnian/Serbian/Croatian labeling all under one expert roof.
Who Regulates Medical Devices in Bosnia and Herzegovina?
Medical devices and IVDs in Bosnia and Herzegovina are regulated by the Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (Agencija za lijekove i medicinska sredstva BiH), known as ALMBIH. Established in 2009 and operating at state level under the Ministry of Civil Affairs, ALMBIH is the single authority responsible for registration, control, import oversight and post-market surveillance across the whole country.
Although Bosnia and Herzegovina is not an EU member state, its framework is closely aligned with the EU MDR (2017/745) and IVDR (2017/746), while still recognising legacy MDD/AIMD/IVDD documentation during the transition. The CE mark is the foundation of market access: every device must be entered in the national Register of Medical Devices before it can be placed on the market, and foreign manufacturers must work through a Bosnia based Authorized Representative.
NexorTest manages the entire pathway, from classification and AR appointment to dossier preparation, local language labeling and ALMBIH submission, so your device reaches the Bosnian market quickly and stays compliant for the full 5 year certificate term.
ALMBIH At a Glance
Four Risk Based Device Classes Under ALMBIH
ALMBIH follows the EU risk based model. Your device class determined from your existing CE classification sets the documentation, evidence and route into the Bosnian national register.
Class I Devices
Bandages, non-sterile dressings, basic surgical instruments and patient scales. Sub-classes Is (sterile), Im (measuring) and Ir (reusable surgical) carry added evidence such as sterilization validation.
- Simplified Route
- 90 Days
- 5 Year Validity
Class IIa Devices
Dental devices, infusion sets, surgical masks and short-term invasive devices. Requires a valid CE/EC certificate and the manufacturer’s Declaration of Conformity.
- CE Required
- 90 Days
- DoC Required
Class IIb Devices
Patient monitoring systems, anaesthesia equipment, ventilators and infusion pumps. Full CE technical documentation and Notified Body involvement underpin the file.
- CE Required
- NB Certificate
- 90 Days
Class III Devices
Pacemakers, stents, orthopaedic and other implantable devices. Subject to the highest documentation burden and full CE design evidence.
- CE Required
- Design Evidence
- Full Dossier
Routes to ALMBIH Approval
The right route depends on your device class and the CE evidence you already hold. NexorTest selects and manages the optimal pathway into the Bosnian register.
CE Marking Pathway
Leverage your existing CE marking under the EU MDR/IVDR (or valid legacy MDD/AIMD/IVDD certificates under the transition rules) as the primary basis for ALMBIH registration. Because Bosnia recognises the CE conformity assessment, no separate local conformity assessment is needed.
Simplified Class I Route
For Class I general and IVD devices, ALMBIH offers a simplified procedure based on permission and a Free Sale Certificate, with a lighter documentation set than the standard CE route ideal for low risk product lines.
Local Authorized Representative for Bosnia
Every foreign manufacturer must register through a Bosnia based Authorized Representative/importer under a representation contract or letter of authorization. NexorTest holds your registration as an independent AR so you retain full control.
End-to-End Bosnia Regulatory Consulting
From regulatory strategy and Authorized Representative appointment through documentation, national-register submission and post-market compliance a complete one stop solution for the Bosnian market.
Authorized Representative
Bosnia based Authorized Representative and importer services, including the representation contract or letter of authorization, register holding and acting as your legal liaison with ALMBIH.
Classification & Strategy
Accurate Class I/IIa/IIb/III and IVD determination mapped from your CE/MDR classification, with a tailored ALMBIH submission roadmap and timeline forecast.
Technical Documentation
Preparation and review of CE/EC certificates, Declaration of Conformity, Free Sale Certificate, ISO 13485/9001 evidence and the complete ALMBIH registration dossier.
National Register Submission
End-to-end management of ALMBIH's electronic medical device information system REG MD application and Annex 1, fee payment, dossier upload and application tracking.
Local Language Labeling
Compliant Bosnian/Serbian/Croatian labeling and instructions for use, including certified translation of IFU and dossier ready label artwork.
MDR / IVDR Transition
Guidance on the move from MDD/AIMD/IVDD to the MDR and IVDR, including ALMBIH's transitional recognition rules for valid legacy EC certificates.
IVD & SaMD Registration
Specialized support for In Vitro Diagnostics and Software as a Medical Device, covering performance evidence, software lifecycle and digital-health documentation.
Free Sale & Simplified Route
Management of the Class I simplified procedure based on permission and the Free Sale Certificate, plus advice on which route is fastest for your portfolio.
Post-Market & Renewals
Change notifications, register updates, license transfers and timely 5 year certificate renewals so your registrations never lapse.
Six Steps to Your ALMBIH Registration Certificate
A structured, CE reliance approach designed to reduce ALMBIH review queries and speed your medical device approval in Bosnia and Herzegovina.
Appoint Authorized Representative
We act as your Bosnia based AR/importer under a representation contract or letter of authorization, ready to submit to ALMBIH on your behalf.
Classification & CE Strategy
We confirm your Class I/IIa/IIb/III or IVD status from your CE file and define the standard CE route or Class I simplified procedure.
Dossier Preparation
We assemble the CE/EC certificate, Declaration of Conformity, Free Sale Certificate, ISO 13485/9001, technical file and translated labeling.
National Register Submission
We complete the REG MD form and Annex 1, pay the applicable fees and submit through ALMBIH’s electronic information system.
Review & Query Management
We manage ALMBIH’s technical review within the 90 day window and respond promptly to any requests for additional documentation.
Certificate & Post-Market
You receive a 5 year registration certificate; we handle change notifications, register updates and renewals before expiry.
ALMBIH Registration Document Checklist
ALMBIH requires a complete, properly certified dossier. Documents in other languages need a certified translation, and IFU/labeling must be provided in Bosnian, Serbian or Croatian.
| Document | Description & Guidance |
|---|---|
| REG-MD Application Form + Annex 1 | The registration application form for the appropriate class, signed and certified by the applicant, submitted together with Annex 1 through the ALMBIH national information system. |
| Proof of Authorized Representation | Representation contract or letter of authorization confirming your Bosnia-based Authorized Representative/importer, in original or certified copy. |
| CE / EC Certificate of Conformity Class IIa+ | CE certificate or EC certificate issued by an EU Notified Body, in original or certified copy. Required for all classes except certain Class I devices under the simplified route. |
| Declaration of Conformity | Manufacturer's signed declaration stating compliance with the applicable EU directive/regulation and specifying the exact device class. |
| Free Sale Certificate | Proof the device is marketed in the country of manufacture or an EU country, central to the Class I simplified route and supportive for all classes. |
| ISO 13485 / ISO 9001 Certificate | Valid quality-management-system certificate covering the manufacturing site, issued by an accredited certification body and subject to validation in the register. |
| IFU & Labeling (Local Language) | Instructions for use in the original language plus a proposal in Bosnian, Serbian or Croatian, with compliant inner and outer labeling showing the AR's details. |
| Measuring-Function Confirmation If applicable | Confirmation of measuring compliance for medical devices with a measuring function (Im sub-class). |
| Proof of Fee Payment | Evidence of payment of ALMBIH agency fees (which scale with the number of products) and administrative fees. |
ALMBIH Registration Across All Device Sectors
Our regulatory team supports manufacturers across the full spectrum of medical technology and IVD categories entering Bosnia and Herzegovina and the wider Western Balkans.
- 🏥 Cardiovascular Devices
- 🦴 Orthopedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 💡 AI/ML Based Medical Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
- � Imaging & Radiology
ALMBIH Medical Device Registration FAQ's
Who regulates medical devices in Bosnia and Herzegovina?
The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBIH, Agencija za lijekove i medicinska sredstva BiH) a state level body established in 2009 under the Ministry of Civil Affairs regulates all medical devices and IVDs. It handles classification, registration, import oversight and post-market surveillance. Every device must be entered in the national Register of Medical Devices before it can be placed on the market.
Do I need an Authorized Representative in Bosnia?
Yes, Foreign manufacturers without a legal entity in Bosnia and Herzegovina must appoint a Bosnia based Authorized Representative/importer. All applications to ALMBIH are filed through this local representative, evidenced by a representation contract or letter of authorization. NexorTest provides independent Authorized Representative services so you keep ownership and control of your registrations.
Does Bosnia accept the CE mark?
Yes, Bosnia is not in the EU, but its system is built on EU regulations and the CE mark is the foundation of ALMBIH registration. A valid CE/EC certificate plus the Declaration of Conformity is the primary evidence for Class IIa, IIb and III devices, so CE marked manufacturers avoid a separate local conformity assessment. Class I general and IVD devices may use a simplified route based on permission and a Free Sale Certificate.
How long does ALMBIH registration take?
ALMBIH reviews a complete application in approximately 90 days across all classes, including IVDs. The clock starts once the agency considers the dossier complete, so the practical timeline depends on how fast a fully certified, correctly translated file is assembled and how quickly you respond to any agency queries. There is no local product testing or local clinical study requirement.
What documents are required for registration?
Core documents include the REG MD application form and Annex 1, proof of authorized representation, the CE/EC certificate (except certain Class I devices), the Declaration of Conformity, a Free Sale Certificate, a valid ISO 13485/9001 certificate, IFU and labeling with a Bosnian/Serbian/Croatian proposal, measuring function confirmation where relevant, and proof of fee payment.
How long is an ALMBIH certificate valid?
An ALMBIH registration certificate is valid for 5 years from issue. Renewal should begin before expiry with current CE certificates, an updated ISO certificate and details of any changes. During validity you must notify ALMBIH of changes to the device, manufacturer, packaging, labeling or storage conditions, and a registration can be transferred to a new holder with additional paperwork.
Ready to Enter the Bosnian Market?
Get a free ALMBIH regulatory assessment from our Bosnia focused specialists. We’ll map your fastest, lowest risk path to a 5 year ALMBIH registration certificate.