Saint Pierre and Miquelon is a French overseas collectivity located near Canada. Although it is outside the EU customs territory, it follows French national laws and regulatory systems, including EU product compliance rules such as CE marking, REACH, RoHS, and others. Product entry and safety are controlled using French and EU frameworks adapted for local administration.

Key Authorities:

• Préfecture of Saint Pierre and Miquelon – Acts as the local representative of the French state and coordinates regulatory implementation.

• French Directorate-General for Competition, Consumer Affairs, and Fraud Control (DGCCRF) – Enforces product safety laws, market surveillance, and consumer protection.

• Agence Nationale de Sécurité du Médicament (ANSM) – Oversees pharmaceuticals, medical devices, and health products, using French/EU procedures.

• ARCEP France – Regulates telecommunications and RF equipment under the EU RED framework.

• French Customs (Douanes Françaises) – Controls imports and checks conformity documents even though the territory is outside EU VAT/customs zones.

Key Compliance Elements:

• Accepted Standards:

  • Products must comply with:

    • French national regulations and EU directives

    • CE marking, REACH, RoHS, WEEE, Eco-design, and other EU conformity frameworks

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

• Product Registration:

  • Required for:

    • Medicines and vaccines (via ANSM or EMA)

    • Medical devices (via EUDAMED)

    • Cosmetics and dietary supplements (via CPNP portal and French laws)

  • Products approved for the French or EU market are automatically accepted in Saint Pierre and Miquelon.

• Telecom Equipment (ARCEP):

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

  • No separate approval is needed beyond French/EU conformity.

• Labeling Requirements:

  • Labels must be in French, and include:

    • Product name

    • Country of origin

    • Manufacturer/importer information

    • CE mark (if applicable)

    • Safety warnings and instructions

    • Expiry or batch number (for regulated products)

• Import Oversight:

  • French Customs handles all product entry, requiring:

    • CE documentation or French conformity proof

    • Product registration documents (if regulated)

    • Invoice and packing list

    • Certificate of origin

    • Standard French customs declaration

• Market Surveillance:

Conducted by DGCCRF, working with local prefecture and customs officials. Target areas include health goods, electrical safety, and labeling compliance.