Kosovo is a developing market with a growing product compliance framework that closely follows European Union standards, even though it is not yet an EU member. The government is aligning its regulations with the EU acquis communautaire, especially for CE-marked goods, consumer protection, and technical safety.

Key Authorities:

• Kosovo Standardization Agency (AKS) – Develops and adopts national standards, often harmonized with EN (European) and ISO standards.

• Ministry of Industry, Entrepreneurship and Trade (MIET) – Oversees technical regulations, market surveillance, and consumer protection.

• Agency for Medicinal Products and Medical Devices (AKPPM) – Regulates pharmaceuticals, medical devices, and health supplements.

• Telecommunications Regulatory Authority (ARKEP) – Manages type approval for telecom and wireless devices.

• Kosovo Customs – Enforces import documentation and verifies compliance with applicable technical regulations.

Key Compliance Elements:

• Accepted Standards:

  • Kosovo accepts products that comply with EU directives and bear the CE mark.

  • Many products are regulated under EU-aligned technical regulations, with local transposition into Kosovo’s legal framework.

• Product Registration:

  • Mandatory for:

    • Pharmaceuticals and medicines

    • Medical devices

    • Cosmetics and food supplements

  • Registration must be completed through AKPPM, and requires product dossiers, labeling, and safety documentation.

• Type Approval (ARKEP):

  • All telecom and wireless equipment (e.g., mobile phones, routers, IoT devices) must receive ARKEP type approval.

  • CE marking and test reports from EU-recognized labs may streamline the process.

• Labeling Requirements:

  • Labels must be in Albanian and/or Serbian, and include:

    • Product name

    • Manufacturer/importer contact

    • Country of origin

    • Usage instructions and warnings

    • Certification mark (CE, ARKEP ID, etc.)

    • Expiry date or batch number (if applicable)

• Import Control:

  • Kosovo Customs requires:

    • Certificate of origin

    • Invoice and packing list

    • Product registration or type approval (for regulated goods)

    • CE Declaration of Conformity (DoC) for CE-marked goods

• Market Surveillance:

  • The Market Inspectorate under MIET inspects products in the market and can impose penalties or recalls for non-compliant goods.