1. Consejo Nacional de Calidad (CNC)

CNC coordinates the national quality system, supports standardization, metrology, accreditation, and conformity assessment activities. It works to align national practices with international standards.

2. Organismo Salvadoreño de Reglamentación Técnica (OSARTEC)

OSARTEC is the technical regulation body responsible for developing and enforcing mandatory product standards and technical regulations.

3. Dirección Nacional de Medicamentos (DNM)

DNM regulates pharmaceuticals, cosmetics, natural products, and medical devices. It oversees product registration, import approval, and post-market surveillance in the health sector.

4. Ministerio de Salud (MINSAL)

MINSAL monitors public health compliance, particularly in food safety, water quality, and environmental health standards.

5. Superintendencia General de Electricidad y Telecomunicaciones (SIGET)

SIGET oversees the type approval of telecommunications and radio frequency equipment. It ensures devices meet technical specifications before being sold or used in El Salvador.

6. Dirección General de Aduanas

The customs authority verifies that imported goods meet documentation and compliance requirements, including health, safety, and labeling standards.

Product Certification and Compliance Requirements

• Technical Regulations and Standards: Many product categories must comply with mandatory technical regulations. These include safety, labeling, and performance requirements for sectors such as food, chemicals, electrical devices, and construction materials.

• Certificate of Conformity: Certain regulated products may require a conformity certificate from an accredited body confirming that they meet applicable technical requirements.

• Health Product Registration: Pharmaceuticals, cosmetics, dietary supplements, and medical devices must be registered with DNM before import or sale. This includes a technical file, test data, labeling review, and local representation.

• Type Approval for Telecom Equipment: Devices that use radio frequency (Wi-Fi, Bluetooth, cellular, etc.) must be type approved by SIGET. Approval is based on compliance with recognized technical standards.

• Labeling Requirements: Labels must be in Spanish and must include product name, manufacturer/importer information, country of origin, lot number, net content, expiration date (if applicable), usage instructions, and warnings when required.

• Import and Customs Requirements: Importers must submit commercial invoices, certificates of origin, product registrations, and in some cases, test reports or certificates of conformity for clearance.

• Market Surveillance: Regulatory agencies inspect products in the marketplace and at customs to ensure compliance with safety and quality regulations. Non-compliant goods may be removed from the market or returned to origin.