1. Institute for Standardization of Bosnia and Herzegovina (ISBIH)

ISBIH is the national body responsible for developing and implementing technical standards in BiH. It participates in establishing and maintaining a system of certification and homologation in accordance with the European model. ISBIH represents BiH in European and international organizations for conformity assessment, such as EOTC and EUROLAB . 

2. Institute for Accreditation of Bosnia and Herzegovina (BATA)

BATA is the national accreditation body that accredits conformity assessment bodies, including testing and calibration laboratories, certification bodies, and inspection agencies. It ensures that these bodies operate competently and consistently .

3. Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina (ALMBIH)

ALMBIH is the regulatory authority for medicines and medical devices in BiH. It is responsible for authorizing medicines based on assessments of quality, efficacy, safety, and risk/benefit ratio. ALMBIH also oversees pharmacovigilance activities . 

4. Communications Regulatory Agency (CRA)

CRA regulates the telecommunications and broadcasting sectors in BiH. It manages the type approval process for telecommunications and electronic equipment, ensuring compliance with national technical requirements . 

5. Indirect Taxation Authority (ITA)

ITA is responsible for the application and implementation of legal regulations related to indirect taxation in BiH, including customs duties, excise taxes, and value-added tax. It plays a role in ensuring that imported products comply with national standards and regulations . 

Product Certification and Compliance Requirements

• Conformity Assessment: Before placing a product on the market in BiH, the manufacturer or its authorized representative must assess whether the product conforms to current technical regulations. The Law on Technical Requirements defines the assessment procedures for products and on conformity assessment. Conformity documents and markings issued abroad are recognized in BiH if they are issued in accordance with international agreements on mutual recognition of documents to which BiH is a signatory . 

• Labeling and Marking Requirements: Products must adhere to labeling requirements as specified by the relevant authorities. This includes information such as product name, manufacturer details, country of origin, net weight/volume, list of contents, production and expiration dates, and lot identification. Labels must be in one of the official languages of BiH.

• Type Approval for Telecommunications Equipment: For telecommunications equipment, type approval certificates are required. CRA bases its conformity assessment on European Union directives, and compliance with these directives is sufficient to meet national requirements . 

• Recognition of Foreign Conformity Documents: The Ministry of Foreign Trade and Economic Relations may recognize the validity of conformity documents and conformity markings issued in countries with which BiH has not signed international agreements if they have been issued in accordance with technical regulations equivalent to those adopted by BiH .