Serbia has a comprehensive product compliance framework that is closely aligned with European Union regulations due to its status as an EU candidate country. Serbia has harmonized many of its laws with EU directives, including requirements for CE marking, REACH, RoHS, and eco-design. The country also enforces national product safety regulations through its own technical standards and conformity assessment bodies.

Key Authorities:

• Institute for Standardization of Serbia (ISS) – Develops and manages Serbian Standards (SRPS), harmonized with EN, ISO, and IEC.

• Ministry of Health – Regulates pharmaceuticals, medical devices, cosmetics, and food supplements, including registration and market surveillance.

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

• Market Inspection Division (Ministry of Trade) – Conducts market surveillance and enforces product safety and labeling laws.

• Serbian Customs Administration – Enforces import regulations and compliance at borders.

Key Compliance Elements:

• CE Marking & EU Alignment:

  • Serbia requires CE marking for many regulated product categories, such as:

    • Electrical and electronic equipment

    • Toys and PPE

    • Machinery and construction products

    • Medical devices

  • Products must include:

    • CE marking affixed

    • Declaration of Conformity (DoC)

    • Complete technical documentation per applicable EU directives

• Product Registration (Ministry of Health):

  • Required for:

    • Medicines and vaccines

    • Medical devices (Class I–III)

    • Cosmetics and dietary supplements

  • Requires:

    • Product dossier with safety/efficacy data

    • Certificates like GMP, CE, or ISO 13485

    • Labeling in Serbian (Cyrillic or Latin)

    • Local authorized representative

• Telecom Type Approval (RATEL):

  • All RF and telecom devices must be approved by RATEL before import or sale.

  • Requires:

    • Technical documents and specifications

    • CE or FCC certificates as supporting evidence

    • Application through a local representative

  • Approved products must comply with Serbia’s frequency spectrum regulations.

• Labeling Requirements:

  • Labels must be in Serbian, and include:

    • Product name

    • Manufacturer/importer contact

    • Country of origin

    • CE mark (if applicable)

    • Instructions for use and safety warnings

    • Expiry or batch number (for regulated goods)

• Environmental Compliance:

  • Serbia enforces:

    • RoHS (for electronics)

    • REACH (chemical safety)

    • WEEE (electronic waste recycling)

    • Eco-design and energy labeling (aligned with EU legislation)

• Import Oversight:

  • Importers must provide:

    • CE documentation and DoC (if applicable)

    • Product registration certificates (for regulated products)

    • Invoice, packing list, and certificate of origin

    • Telecom type approval certificate (if applicable)

    • Customs declaration under Serbian import regulations

• Market Surveillance:

Conducted by the Market Inspection Division, Ministry of Health, and RATEL, focusing on consumer safety, product labeling, and regulatory compliance. Non-compliant products may be withdrawn from the market or subject to penalties.