San Marino, though an independent microstate, is highly integrated with Italy and the European Union for its regulatory framework. While it is not an EU member, it follows many EU product compliance regulations, including CE marking, through bilateral agreements and its customs union with Italy. Products imported into or sold in San Marino must generally meet EU standards for safety, health, and environmental compliance.

Key Authorities:

• Ufficio Industria, Artigianato e Commercio (Industry, Handicraft and Commerce Office) – Oversees product compliance and commercial regulations.

• Istituto per la Sicurezza Sociale (ISS) – Regulates pharmaceuticals, medical devices, and public health-related products.

• Agenzia per l’Informazione e la Comunicazione (Agency for Information and Communication) – Manages telecom and RF equipment regulation, often in coordination with Italian authorities.

• San Marino Customs Office – Controls imports and ensures that products meet required compliance regulations at the border.

Key Compliance Elements:

• Accepted Standards:

  • San Marino accepts products that comply with:

    • EU Directives and Regulations, including CE marking

    • Italian national regulations, due to the customs union

    • International standards (ISO, IEC, Codex) are also widely recognized

• Product Registration:

  • Required for:

    • Pharmaceuticals and vaccines

    • Medical devices and diagnostics

    • Food supplements and cosmetics

  • Registration typically requires:

    • CE marking and registration in the EU or Italy

    • Product dossiers and safety/efficacy data

    • Labels in Italian (bilingual labeling is acceptable)

• Telecom Equipment:

  • Must comply with the EU Radio Equipment Directive (RED) and bear the CE mark.

  • No additional local type approval is typically required; equipment approved in Italy or the EU is accepted.

• Labeling Requirements:

  • Labels must be in Italian, 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 products)

• Import Oversight:

  • Imports go through San Marino Customs but follow Italian and EU customs procedures.

  • Required documents:

    • CE documentation and Declaration of Conformity

    • Product registration certificates (if applicable)

    • Invoice and packing list

    • Certificate of origin

• Market Surveillance:

Conducted by the Commerce Office, ISS, and customs authorities. They focus on verifying CE compliance, product labeling, and health and safety standards. Non-compliant products may be recalled, fined, or blocked from entry.