SAUDI ARABIA

SAUDI ARABIA

Medwisdom Lifescience provides dedicated, SFDA-compliant Regulatory Affairs services for the Saudi market — ensuring seamless market entry and compliance for pharmaceuticals, biologics, medical devices, cosmetics, and nutraceuticals through expert dossier preparation, submissions, and lifecycle management.

Overview

The Saudi Food and Drug Authority (SFDA) is the primary regulatory authority overseeing the approval and monitoring of pharmaceuticals, biologics, medical devices, cosmetics, and nutraceuticals in Saudi Arabia. Established to ensure product safety, efficacy, and quality, SFDA aligns with international standards like ICH and WHO while incorporating local requirements such as Arabic labeling and climate-specific stability testing.

Regulatory Affairs (RA) in Saudi Arabia involves navigating a structured yet rigorous process for market authorization, with pathways varying by product type. Medwisdom guides clients through every step, minimizing delays and ensuring compliance.

Registration Process for Drugs and Medical Devices

The SFDA employs a centralized submission system via its electronic portal for all product registrations. Here's an overview of the key processes:

• Drugs and Biologics
  1. Product classification (e.g., prescription, OTC, biologic). 2. Appoint a local authorized representative. 3. Prepare and submit eCTD dossier including CMC data, stability studies, clinical/non-clinical data, and labeling. 4. SFDA screening and technical review. 5. Address queries and obtain approval certificate valid for 5 years.
• Medical Devices and IVDs
  1. Risk-based classification (Class I-IV). 2. Appoint local representative. 3. Submit technical dossier with design files, clinical evaluation, labeling, and UDI compliance. 4. SFDA review and MDMA (Medical Device Marketing Authorization) issuance, valid for 3 years for some pathways.

For cosmetics and nutraceuticals, a notification or simplified submission may suffice, focusing on ingredient safety and labeling compliance.

Tentative Registration Timelines

Timelines can vary based on dossier completeness, SFDA workload, and query resolution. Reliance pathways (e.g., FDA/EMA approvals) can accelerate processes.

Challenges in Saudi Arabia Regulatory Affairs

Navigating SFDA regulations can be complex for foreign applicants due to:

• Extensive legal framework (~70 laws/regulations) requiring deep local knowledge
• Language barriers (Arabic mandatory for labeling/submissions)
• Mandatory local authorized representative and import licensing
• Dossier format issues (eCTD compliance) and frequent queries/deficiencies
• Climate-specific stability testing for Zone IVb conditions
• Backlogs and delays in high-volume submissions or inspections

Medwisdom's expertise helps overcome these by providing proactive strategies, local partnerships, and flawless submissions.

Our Regulatory Affairs Services for Saudi Arabia

Why Choose Medwisdom for Saudi Regulatory Affairs

• In-depth understanding of SFDA requirements across all product types
• End-to-end RA services from classification to post-approval
• Multidisciplinary expertise in regulatory, CMC, and device specialists
• Efficient submissions for faster approvals and minimal queries
• Full local agent and importer support for seamless coordination
• Comprehensive coverage for devices, cosmetics, and nutraceuticals
• Proactive regulatory intelligence to avoid compliance issues
• Transparent communication with regular updates and tracking