São Tomé and Príncipe operates a developing product compliance system focused on public health, consumer protection, and import quality control. Due to its limited local testing and regulatory infrastructure, the country relies heavily on import controls and acceptance of products that comply with recognized international standards (ISO, IEC, Codex) and foreign certifications.

Key Authorities:

• General Directorate for Commerce and Industry (DGCI) – Manages trade policies, market surveillance, and consumer protection.

• Ministry of Health – Regulates pharmaceuticals, medical devices, cosmetics, and food products, including product registration and health permits.

• National Communications Authority (ANAC) – Oversees telecom and RF equipment, including licensing and frequency management.

• Customs Directorate – Verifies import documentation and ensures compliance with import and regulatory requirements.

Key Compliance Elements:

• Accepted Standards:

  • Products are generally required to comply with:

    • ISO and IEC standards

    • Codex Alimentarius for food safety

    • Certifications from authorities such as the EU (CE marking), U.S. FDA, or FCC are often accepted to demonstrate compliance.

  • There is no national conformity mark or dedicated certification body.

• Product Registration (Ministry of Health):

  • Required for:

    • Medicines and vaccines

    • Medical devices

    • Food supplements and cosmetics

  • Registration includes:

    • Product dossier with safety and efficacy information

    • Certificate of Free Sale or GMP certification from the country of origin

    • Labels in Portuguese

    • Import permit for controlled products

• Telecom Type Approval (ANAC):

  • While no formal national type approval system exists, telecom and RF devices must:

    • Comply with recognized foreign certifications (e.g., CE or FCC)

    • Be compatible with national frequency allocations

    • Obtain import authorization through ANAC or a local representative

• Labeling Requirements:

  • Labels must be in Portuguese, and include:

    • Product name

    • Manufacturer/importer contact details

    • Country of origin

    • Usage instructions and safety warnings

    • Expiry or batch number (for food and health-related products)

    • Certification or registration number (if applicable)

• Import Oversight:

  • Importers must submit:

    • Invoice and packing list

    • Certificate of origin

    • Product registration (for health-regulated products)

    • Certificate of conformity or recognized foreign certifications

    • Customs declaration and import permit (if required)

• Market Surveillance:

Conducted by DGCI, the Ministry of Health, and Customs. Inspections primarily focus on public health products, labeling compliance, and preventing counterfeit goods. Non-compliant products may be denied entry or removed from the market.