Medical Device Compliance in Saudi Arabia: What You Need & How to Get Approved
Who regulates medical devices in KSA?
Medical devices are regulated by the Saudi Food & Drug Authority (SFDA). SFDA oversees establishment licensing, product authorization, market listing/registries, and post-market surveillance for all medical devices in the Kingdom.
2) The core approvals you’ll deal with
A) Establishment licensing (company-level)
Any manufacturer, Authorized Representative (AR), importer, or distributor operating in KSA must hold a valid Medical Device Establishment License issued by SFDA. This confirms your legal status to import, distribute, or represent devices in the Kingdom
If you’re a foreign manufacturer, you must appoint a Saudi Authorized Representative (AR). The AR is your legally recognized liaison with SFDA for registration, vigilance, and communications; it does not have to be your distributor.
B) Product-level authorization (device-level)
Before marketing any device in KSA, you need Medical Device Marketing Authorization (MDMA)—SFDA’s product approval. The technical file is assessed for safety, quality, and performance (aligned to recognized international evidence). The end result is the MDMA certificate, which allows you to place the device on the Saudi market.
Cosmetic Product Compliance in Saudi Arabia: Your Path to SFDA Approval
All cosmetic and personal care products placed on the Saudi Arabian market must comply with the regulations of the Saudi Food and Drug Authority (SFDA). SFDA ensures that every product is safe, effective, and properly labeled before it reaches consumers.
The SFDA regulates cosmetics under the Cosmetic Products Regulation, which aligns with international safety standards (such as EU Regulation EC No. 1223/2009). Any company that wishes to manufacture, import, or distribute cosmetics in Saudi Arabia must be licensed and register its products in the SFDA system.
Key Compliance Requirements
A) Establishment Licensing
All entities involved in the importation, manufacturing, or distribution of cosmetics must hold a valid SFDA establishment license.
This ensures the company operates within the authority’s legal and safety framework.
B) Product Notification
Each cosmetic product must be notified to SFDA through the GHAD electronic system before it can be marketed.
The notification includes:
Product composition and function
Label and artwork (Arabic & English)
Safety and efficacy evidence for claimed benefits
Good Manufacturing Practice (GMP) certificate from the manufacturer’s country
Free Sale Certificate (FSC) or equivalent regulatory approval
Pharmacovigilance (PV) Compliance in Saudi Arabia
Key Saudi FDA pharmacovigilance requirements include:
A) Appointment of a Local QPPV (Qualified Person for Pharmacovigilance)
Each MAH must appoint a Saudi-based QPPV approved by SFDA.
Responsibilities include:
Overseeing the company’s PV system and ensuring continuous compliance.
Monitoring and evaluating adverse event reports from healthcare professionals and patients.
Submitting timely and accurate safety reports to SFDA.
Maintaining the Pharmacovigilance System Master File (PSMF).
Acting as the primary contact with SFDA during inspections or safety evaluations.
B) Pharmacovigilance System Master File (PSMF)
The MAH must maintain a detailed PSMF describing the structure, processes, and personnel responsible for pharmacovigilance.
This file should be available for inspection at any time and include both global and Saudi-specific components.
C) Adverse Event Reporting
Serious Adverse Events (SAEs): Must be reported to SFDA within 15 calendar days.
Non-serious events: Should be included in Periodic Safety Update Reports (PSURs).
Continuous monitoring of literature, spontaneous reports, and signal data is required.
D) Periodic Reports and Signal Management
SFDA requires submission of PSURs/PBRERs and proactive signal detection to evaluate emerging safety concerns.
MAHs must maintain a systematic risk management process to assess and mitigate potential product risks.
E) SFDA PV Inspections
SFDA conducts regular inspections to ensure companies have effective PV systems in place. Findings of non-compliance can result in regulatory warnings, license suspension, or market withdrawal of the product.