North Macedonia has an established product compliance framework that is closely aligned with European Union legislation due to its EU candidate status. The country applies CE marking rules, national conformity assessment procedures, and mandatory product registration for regulated sectors, including medical, electrical, food, and telecom equipment.

Key Authorities:

• Institute for Standardization of North Macedonia (ISRM) – Develops national standards (MKS), many of which are harmonized with EN, ISO, and IEC standards.

• State Market Inspectorate – Conducts market surveillance, product safety checks, and enforcement of CE marking.

• Agency for Medicines and Medical Devices (MALMED) – Regulates pharmaceuticals, medical devices, and health supplements, including product registration.

• Agency for Electronic Communications (AEC) – Oversees type approval, spectrum management, and compliance for telecom and RF equipment.

• Customs Administration – Verifies regulatory documents and enforces import controls.

Key Compliance Elements:

• CE Marking & Harmonization with EU:

  • North Macedonia has transposed key EU directives into national law (e.g., LVD, EMC, RED, Toys, Machinery, PPE).

  • Products must carry the CE mark and be supported by a:

    • Declaration of Conformity (DoC)

    • Technical documentation

  • Third-party certification may be needed depending on product category and risk level.

• Product Registration:

  • Required for:

    • Medicines and vaccines

    • Medical devices (Class I–III)

    • Food supplements and cosmetics

  • Administered by MALMED, and requires:

    • Safety and efficacy documentation

    • GMP or ISO certification

    • Labeling in Macedonian

    • Samples and free sale certificates

• Telecom Type Approval (AEC):

  • All telecom and RF devices must be type approved.

  • CE-certified devices benefit from a simplified process, but local documentation and approval are still required.

  • Registered equipment receives a certificate and may be listed publicly by AEC.

• Labeling Requirements:

  • Labels must be in Macedonian, and include:

    • Product name

    • Country of origin

    • Manufacturer/importer contact

    • CE mark (if applicable)

    • Usage instructions and safety warnings

    • Expiry or batch number (for regulated goods)

• Import Oversight:

  • Importers must present:

    • CE documentation and DoC

    • Certificate of origin

    • Product registration certificates (if applicable)

    • Invoice and packing list

    • Type approval certificate (for telecom devices)

• Market Surveillance:

The State Market Inspectorate, MALMED, and AEC conduct inspections, testing, and enforcement. Non-compliant products may be recalled, fined, or prohibited from sale.