SFDA Approval for Medical Devices | Saudi FDA Registration Support

SFDA Approval for Medical Devices – Saudi FDA Registration Services

SFDA approval is mandatory for medical device manufacturers who want to export products to Saudi Arabia. Without approval from the Saudi Food and Drug Authority (SFDA), your products cannot clear customs or enter the Saudi medical market.

Operon Strategist provides end-to-end SFDA medical device registration support for Brazilian manufacturers who want to expand into Saudi Arabia and the Middle East. Our regulatory experts handle documentation, technical compliance, MDMA submissions and communication with SFDA to ensure fast approval and market access.

What is SFDA Approval?

SFDA Approval is a regulatory authorization that ensures medical devices are safe, effective, and compliant with Saudi healthcare regulations. All manufacturers must register products under the Medical Device Market Authorization (MDMA) system before distribution in Saudi Arabia.

Even if your device already has ANVISA, CE Marking, or US FDA approval, SFDA approval is still required.

SFDA Medical Device Registration Process

We guide Brazilian manufacturers through each stage of the Saudi medical device registration process, including:

Classification of Medical Devices – Determining risk category according to SFDA rules.
Appointment of Local Authorized Representative (LAR) – Required for all foreign manufacturers.
Preparation of Technical Documentation – Aligning with SFDA guidance and GHTF standards.
Submission to SFDA – Filing applications via the Medical Device Marketing Authorization (MDMA) system.
Review & Approval – Managing queries, addressing compliance gaps, and ensuring timely approval.
Post-Market Surveillance (PMS) – Assisting with vigilance reporting, renewals, and compliance maintenance.

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SFDA Medical Device Classification

Class	Risk Level	Examples
Class A	Low Risk	Surgical gloves, tongue depressors
Class B	Low–Moderate Risk	Infusion sets, suction equipment
Class C	High Risk	Ultrasound, anesthesia equipment
Class D	Highest Risk	Pacemakers, stents, implantables

Documents Required for SFDA Approval

ISO 13485:2016 Certificate
Free Sale Certificate (FSC)
Declaration of Conformity
Device Description & Intended Use
Label & IFU (English + Arabic)
Risk Management File (ISO 14971)
Clinical Evaluation Report (CER)
Performance Evaluation (for IVDs)
Biocompatibility & Electrical Safety Reports
PMS & Vigilance Plan
Manufacturer Authorization Letter
Saudi-based Authorized Representative Agreement

Who Needs SFDA Medical Device Registration?

SFDA approval is required for:

Medical device manufacturers exporting products to Saudi Arabia
Brazilian companies entering the Middle East healthcare market
OEMs/private label manufacturers
Importers and distributors in Saudi Arabia
Companies participating in Saudi government tenders

Devices covered include:

Active devices
Non-active devices
Sterile/Non-sterile devices
Diagnostic devices (IVDs)
Implantable devices

Get SFDA Approval for Your Medical Device

How Operon Strategist Supports Brazilian Manufacturers

Our consulting services are designed to reduce delays and increase approval success rates:

Regulatory Strategy Development – Customized roadmap for SFDA approval.
Technical Documentation Support – Guidance on dossiers, labeling, and quality certifications.
Local Representation – Support in appointing a reliable Saudi Authorized Representative.
End-to-End Project Management – From initial classification to final approval.
Post-Approval Compliance – Assistance with renewals, vigilance, and regulatory updates.