Drugdu.com expert's response:

The core of entering the Saudi market is mandatory registration and certification with the Saudi Food and Drug Authority (SFDA), along with a series of supporting requirements. The following breaks them down by priority.

I. Core Certification That Must Be Completed: SFDA Medical Device Registration

This is the only legal entry requirement for all medical devices. Unregistered products cannot clear customs or be sold.

Registration Process:

Submit registration application through the SFDA online system (MDMA / Saudi Drug Registration System)

Submit complete technical documentation; SFDA conducts document review

Medium-to-high risk products may be required to provide additional test reports or undergo on-site audits

Upon approval, a registration certificate is issued (typically valid for 5 years, renewable upon expiry)

II. Products Classified by Risk Level — Requirements Differ

SFDA classifies medical devices into four classes. The higher the class, the stricter the review:

Class I (Low Risk) — e.g., surgical blades, bandages, thermometers. Basic product information plus a declaration of conformity is sufficient; clinical trials are generally not required.

Class II (Medium Risk) — e.g., glucose meters, ultrasound devices, infusion pumps. Performance test reports plus clinical data or a clinical evaluation report are required.

Class III (High Risk) — e.g., cardiac pacemakers, artificial joints, implants. Detailed clinical trial data, risk management report, and comprehensive performance verification are required.

Class IV (Very High Risk) — e.g., high-risk implants, life-support devices. The most stringent review; extremely detailed clinical and safety data are required.

III. Core Document Checklist That Must Be Submitted

Registration application form (submitted via SFDA online platform)

Product technical documentation: design description, performance parameters, instructions for use (IFU), manufacturing process

Quality Management System certificate: ISO 13485 certification (mandatory)

Risk management report: prepared per ISO 14971

Clinical evaluation / clinical trial data: generally required for Class II and above; mandatory for Class III

Performance test reports:

Electrical safety: IEC 60601 series

Biocompatibility: ISO 10993 series

Electromagnetic compatibility: IEC 60601-1-2

Products containing software: IEC 62304

Product labels and IFU: must be in Arabic + English bilingual versions

Marketing authorization: if CE / FDA approval has already been obtained, it can be submitted as supporting material to accelerate review

UDI data: since September 2023, Class B/C/D (medium-to-high risk) products are required to implement UDI (Unique Device Identification)

IV. Mandatory Supporting Requirements

Must appoint a Saudi local authorized agent

Foreign manufacturers cannot register directly. Applications must be submitted through a locally licensed importer/agent in Saudi Arabia. The agent must provide a business license and assume post-registration compliance obligations such as adverse event reporting.

Labels and IFU must be in Arabic + English bilingual

This is a hard requirement. English-only labels cannot be sold in Saudi Arabia. The Arabic version must be reviewed and approved by SFDA.

SABER platform compliance

Since 2019, all imported products into Saudi Arabia (including medical devices) must complete product registration and batch certification (PCoC / SCoC) on the SABER platform. This is a prerequisite for customs clearance.

UDI mandatory implementation

Since September 2023, medium-to-high risk devices must display UDI codes on the product and submit UDI data in the SFDA system.

V. Practical Path to Accelerate Registration

If your product has already obtained CE marking (MDR) or FDA 510(k)/PMA approval, SFDA recognizes these as equivalent bases. You can use the simplified review pathway, significantly shortening the approval cycle — from the standard 6–12 months down to 2–4 months.

So the optimal strategy is: obtain CE or FDA first → secure a Saudi local agent → proceed with SFDA simplified registration → clear the SABER platform → get Arabic labels in place → launch.