New Caledonia is a French overseas territory, and its product compliance system is largely based on French and European Union regulations. While it has some local administrative autonomy, most technical regulations and standards are aligned with French national law, including CE marking, REACH, RoHS, and EU sector-specific regulations.

Key Authorities:

• Government of New Caledonia – Department of Economic Affairs – Oversees consumer protection, market surveillance, and import regulation.

• Direction des Affaires Sanitaires et Sociales (DASS-NC) – Regulates pharmaceuticals, medical devices, cosmetics, and food safety.

• New Caledonia Customs (Douanes NC) – Ensures compliance with import documentation, product declarations, and restricted goods controls.

• ARCEP France – Manages telecom and RF regulation, which also applies in New Caledonia under national jurisdiction.

Key Compliance Elements:

• CE Marking:

  • Required for products covered by EU directives:

    • Electrical/electronic goods

    • Toys and PPE

    • Machinery and construction products

    • Medical devices

  • Products must include:

    • CE mark

    • Declaration of Conformity (DoC)

    • Supporting technical file

• Product Registration:

  • Required for:

    • Medicines and vaccines (via DASS-NC, under ANSM guidance)

    • Medical devices (via EUDAMED)

    • Cosmetics and food supplements (via EU/France systems such as CPNP)

  • Products registered under French/EU procedures are accepted in New Caledonia.

• Telecom Equipment:

  • Must comply with the EU Radio Equipment Directive (RED).

  • Devices with CE marking and RED compliance do not require additional type approval.

• Labeling Requirements:

  • Labels must be in French, and include:

    • Product name

    • Manufacturer/importer details

    • Country of origin

    • CE mark (if applicable)

    • Instructions for use and safety warnings

    • Expiry or batch number (if relevant)

• Environmental Compliance:

  • New Caledonia enforces:

    • RoHS (hazardous substances)

    • REACH (chemicals regulation)

    • Eco-design and energy labeling (for electrical appliances)

    • WEEE (waste electrical and electronic equipment)

• Import Control:

  • Importers must provide:

    • Invoice and packing list

    • CE documentation (if applicable)

    • Product registration evidence (health products)

    • Certificate of origin

    • Customs declaration compliant with French/Douanes NC procedures

• Market Surveillance:

  • Conducted by DASS-NC and Economic Affairs authorities in collaboration with customs.