The Maldives maintains a developing product compliance framework focused on public health, consumer safety, and import control. Due to its heavy reliance on imports, the country emphasizes pre-market approvals and regulatory oversight of specific categories such as pharmaceuticals, food, and telecom equipment. Compliance is often based on international standards (ISO, Codex, IEC).

Key Authorities:

• Maldives Food and Drug Authority (MFDA) – Regulates pharmaceuticals, food products, medical devices, supplements, and cosmetics, including product registration and licensing.

• Ministry of Economic Development (MoED) – Oversees trade policies, import licensing, and general consumer protection.

• Communications Authority of Maldives (CAM) – Manages type approval and spectrum regulation for telecom and wireless equipment.

• Maldives Customs Service – Verifies product documentation and import compliance at entry points.

Key Compliance Elements:

• Product Registration (MFDA):

  • Mandatory for:

    • Medicines and medical devices

    • Cosmetics and food supplements

    • Processed food and beverages

  • Registration requires:

    • Product dossier

    • Safety and efficacy data

    • Certificates of analysis or GMP

    • Labels and package inserts in English or Dhivehi

• Telecom Type Approval (CAM):

  • Required for all wireless, telecom, and RF equipment (e.g., routers, mobile phones, walkie-talkies).

  • CE or FCC certifications may be accepted as supporting documents, but local approval is still mandatory.

  • Approved devices receive a registration certificate and may be inspected at the border.

• Accepted Standards:

  • The Maldives typically accepts products that conform to:

    • ISO, IEC, Codex, and WHO standards

    • CE or FCC certifications (supporting, not substitutive)

  • No national conformity mark or SDoC scheme exists yet.

• Labeling Requirements:

  • Labels must be in English or Dhivehi, and include:

    • Product name

    • Country of origin

    • Manufacturer/importer contact

    • Expiry/batch number (for food, medicine, cosmetics)

    • Usage instructions and safety warnings

    • Registration number (if applicable)

• Import Control:

  • Customs clearance requires:

    • Invoice and packing list

    • Certificate of origin

    • Product registration certificate (if applicable)

    • Telecom type approval (for RF equipment)

    • Health or sanitary permit (for food or pharmaceuticals)

• Market Surveillance:

  • MFDA conducts inspections on pharmacies, food vendors, and retailers for compliance with health and safety standards.