Ultimate 2025 Guide To SFDA & SASO Product Registration In Saudi Arabia

Saudi Arabia has become one of the fastest-growing regulatory markets in the Middle East. With increasing enforcement by the Saudi Food and Drug Authority (SFDA) and the Saudi Standards, Metrology, and Quality Organization (SASO), manufacturers must now follow highly structured, evidence-based registration processes to ensure product access into the Kingdom.

This guide from Maven Regulatory Solutions provides a fully updated 2025-ready framework for SFDA, SASO, SABER, SALEEM, and conformity requirements for all product categories   including medical devices, pharmaceuticals, cosmetics, food, industrial products, electronics, and consumer goods.

The goal: Zero delays. Faster approvals. Total compliance. Smooth Saudi Market Access.

Saudi Arabia’s Regulatory Landscape: 2025 Overview

Saudi Arabia has strengthened its technical and safety regulatory systems under Vision 2030

 resulting in:

• Stricter product conformity controls
• Unified digital systems (SABER, Ghad, SDR, FRCS)
• Enhanced post market and customs-level checks
• Stronger enforcement of labeling, safety, and quality requirements
• Full traceability from manufacturing to importation

To successfully access the Saudi market, manufacturers must comply with two primary regulators:

SFDA Regulates:

• Food & beverages
• Pharmaceuticals & OTC drugs
• Medical devices & IVDs
• Cosmetics & personal care
• Tobacco & nicotine products
• Food-contact materials

SASO Regulates:

• Industrial goods
• Electrical & electronic equipment
• Machinery, appliances, HVAC systems
• Automotive parts, tires, batteries
• Toys, textiles, packaging
• Construction materials

SABER & SALEEM Programs the Backbone of Saudi Product Registration

The SABER portal, operated under the SALEEM Product Safety Program, is mandatory for all regulated and unregulated goods entering Saudi Arabia.

SABER Ensures

• Standardized product registration
• Traceable documentation
• Conformity assessment (PCoC & SCoC)
• Customs clearance compliance
• Faster approval timelines

Detailed Technical Flow of SASO Registration (2025 Updated)

1. Product Classification

Identify the correct technical regulation for your product. Requirements include:

• Product description
• HS code verification
• Technical specification sheets
• Safety documentation
• Electrical ratings (for electronics)
• Material Composition

2. Pre-Registration Compliance

Before registration, ensure:

• Mandatory standards compliance
• Factory audit reports (if applicable)
• Certificate of Conformity (CoC) from an accredited CAB
• QMS compliance (ISO 9001 / ISO 13485 for devices)
• Testing requirements based on risk category

3. Laboratory Testing & Inspection

Testing must be performed through approved laboratories only.

Testing parameters include:

• Safety performance
• EMC & electrical compatibility
• Chemical content verification
• Mechanical & physical testing
• Product durability testing
• Packaging quality & labeling compliance

4. SABER Portal Registration

Submit:

• Commercial registration of importer
• Product details & technical sheets
• Conformity certificates
• Test reports
• Factory certificates (if required)

5. Payment of Applicable Fees

Fees vary based on:

• Product category
• Testing scope
• Conformity evaluation type
• Certification duration

6. SASO Technical Review

The authority reviews:

• Testing accuracy
• Conformity to Saudi standards
• Label compliance
• Safety requirements
• Factory traceability

If discrepancies appear, revisions will be requested.

7. Issuance of SASO Certificate

Upon successful review:

• Product receives SASO Certificate of Conformity
• Product becomes eligible for sales and imports
• SASO Quality Mark may be required (for certain electrical & safety products)

8. Continuous Compliance

Manufacturers must maintain:

• Updated documentation
• Renewed testing (where required)
• Annual certificate verification
• Traceability records
• Market surveillance compliance
• Corrective action if safety issues arise

Categories Requiring SFDA or SASO Registration

Consumer-Oriented Products

• Food & beverages
• Pharmaceuticals & OTC drugs
• Medical devices & IVDs
• Cosmetics & personal care (via Ghad)
• Toys & children’s products
• Tobacco & nicotine products

Industrial & Specialized Products

• Machinery & industrial equipment
• Electronics & household appliances
• Chemicals & pesticides
• Automotive parts
• Packaging materials
• Solar & HVAC systems

SFDA vs SASO Registration

Regulatory Authorities Involved (Updated for 2025)

SFDA

• Evaluates product safety, efficacy, and labeling
• Regulates all health-related products
• Ensures compliance with Saudi GXP standards
• Overseas local & imported product quality

SASO

• Develops & enforces Saudi technical regulations
• Manages SABER & SALEEM conformity processes
• Enforces safety standards

ZATCA

• Ensures shipment-level compliance
• Validates SCoC at customs
• Prevents non-compliant goods from entering

GCC Standardization Organization

• Establish regional technical standards
• Oversees Gulf Conformity Mark (G-Mark)

Why Companies Choose Maven Regulatory Solutions for SFDA & SASO Compliance

Maven provides:

• Complete end-to-end SFDA registration
• Technical documentation preparation
• SABER portal management
• Testing coordination with accredited labs
• Conformity assessment (PCoC + SCoC)
• Labeling & artwork compliance
• Market surveillance support
• Renewal management
• Importer & supplier compliance

Our approach ensures:

• Zero errors
• Reduced approval timelines
• Fully compliant submissions
• Seamless Saudi market entry