Monaco has a unique product compliance framework due to its close customs and regulatory union with France. As a result, Monaco adopts and enforces European Union regulations via French law, including CE marking, REACH, RoHS, WEEE, and other harmonized EU directives. Products sold in Monaco must meet EU conformity standards and follow French procedures for product registration, certification, and labeling.

Key Authorities:

• Direction de l’Expansion Économique (DEE) – Oversees economic regulation, consumer protection, and product safety in Monaco.

• Direction de l’Action Sanitaire (DAS) – Manages pharmaceuticals, cosmetics, medical devices, and public health-related approvals.

• Direction des Communications Électroniques (DCE) – Oversees telecom equipment, frequencies, and electronic communication standards, in cooperation with French ARCEP.

• French Customs (Douanes Françaises) – Enforces customs and product compliance at entry, including conformity with EU technical regulations.

Key Compliance Elements:

• CE Marking:

  • Required for all EU-regulated products, such as:

    • Electrical equipment

    • Toys

    • Medical devices

    • Machinery

    • Construction products

  • Products must carry the CE mark, be supported by a Declaration of Conformity (DoC), and meet applicable EU harmonized standards.

• Product Registration:

  • Required for:

    • Medicines and vaccines (via DAS or French ANSM)

    • Medical devices (via EUDAMED)

    • Cosmetics (via the EU CPNP portal)

    • Food supplements (via French and EU food law)

  • Once registered under the EU system, products may circulate freely within Monaco and the rest of the EU.

• Telecom Equipment:

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

  • No separate national type approval is required if the product already meets EU compliance.

• Labeling Requirements:

  • Labels must be in French, and include:

    • Product name

    • Manufacturer/importer details

    • CE mark (if applicable)

    • Usage instructions and safety warnings

    • Expiry/batch number (for regulated goods)

    • Country of origin

• Environmental Compliance:

  • Monaco follows EU environmental directives through its union with France, including:

    • WEEE (electronic waste collection and recycling)

    • RoHS (restriction of hazardous substances)

    • REACH (chemicals regulation)

    • Energy labeling and packaging waste management

• Import Oversight:

  • Products entering Monaco pass through French customs, which verifies:

    • CE documentation

    • Product registration

    • Invoice and certificate of origin

    • Health or telecom certification (as needed)