SFDA Medical Device Registration Saudi Arabia & GCC
Navigate SFDA's MDMA regulatory framework with confidence. NexorTest provides end-to-end medical device registration services in Saudi Arabia, from classification and authorized representation to full MDMA submission and GCC-wide market access.
Understanding SFDA Registration Routes
Since September 2022, all medical devices require full MDMA authorization. The previous notification route (MDNR) has been cancelled.
MDMA Full Authorization
The current and only pathway for all medical devices (Class A through D) to obtain market authorization in Saudi Arabia. Requires reference market approval.
MDNR (Cancelled Sept 2022)
The Medical Device Notification Route was previously available for lower-risk devices but was cancelled. All existing MDNR registrations must transition to MDMA.
Reference Market Prerequisite
SFDA requires prior approval in at least one reference market: Australia (TGA), Canada, EU (CE), Japan (PMDA), or USA (FDA) before MDMA submission.
Comprehensive SFDA Registration Services
From initial classification to post-market surveillance, NexorTest delivers full-spectrum SFDA regulatory support for medical device manufacturers worldwide.
SFDA MDMA Submission
Complete end-to-end MDMA application preparation and submission management for all device classes, including query resolution with SFDA reviewers.
SFDA Device Classification
Accurate risk-based classification (Class A, B, C, D) aligned with SFDA rules and your reference market classification to ensure correct regulatory pathway.
Saudi Authorized Representative
NexorTest acts as your Saudi Authorized Representative (AR), providing the required in-country regulatory liaison between your company and SFDA.
GCC Regulatory Strategy
Develop a unified regulatory strategy to leverage your SFDA MDMA approval across other GCC states including UAE, Kuwait, Qatar, Bahrain, and Oman.
Technical File Preparation SFDA
Compile and review SFDA-compliant technical documentation including device descriptions, safety data, clinical evidence, labeling, and quality system records.
SFDA Post-Market Surveillance
Ongoing vigilance reporting, periodic safety update reports, and adverse event management to maintain your MDMA authorization throughout its 3-year validity.
Device Relabeling Arabic
Arabic translation and relabeling services compliant with SFDA labeling requirements, including IFU translation and packaging adaptation for the Saudi market.
Kuwait/Qatar/Bahrain Registration
Extend your GCC market presence with parallel registration services in Kuwait, Qatar, and Bahrain, leveraging your Saudi SFDA MDMA certification.
IVD Registration SFDA
Specialized in vitro diagnostic (IVD) device registration with SFDA, including performance evaluation review and IVD-specific classification mapping.
Your Trusted Partner for SFDA Registration
NexorTest combines deep SFDA regulatory expertise with proven operational capability in Saudi Arabia to deliver reliable, efficient medical device market access.
In-Country SFDA Expertise
Dedicated regulatory affairs team based in Saudi Arabia with direct SFDA liaison experience and Arabic-language capability.
Reference Market Integration
We align your FDA, CE, TGA, or other reference market dossier with SFDA-specific requirements to minimize duplication.
End-to-End GCC Coverage
Single-partner solution from SFDA to UAE MOHAP and other GCC regulatory bodies for cohesive regional market access.
Post-Approval Support
Ongoing MDMA maintenance, renewal management, and vigilance reporting to keep your registration active throughout its 3-year lifecycle.
SFDA MDMA Registration Step by Step
Our structured 6-step process ensures systematic, compliant SFDA registration from initial assessment to MDMA certificate issuance.
SFDA Classification & Reference Market Analysis
Determine your device’s SFDA classification (A-D) based on reference market classification and verify eligibility for MDMA submission.
Saudi Authorized Representative Appointment
Establish the required in-country authorized representative and formalize the legal agreement between manufacturer and AR.
Technical File & MDMA Documentation
Prepare SFDA-specific technical file including device description, safety and performance data, labeling, and quality documentation.
SFDA Application Submission
Submit the complete MDMA application through SFDA’s electronic portal with all required documents and applicable fees.
SFDA Review & Query Management
Manage the 35-working-day review process, respond to SFDA queries promptly, and provide any additional information requested.
MDMA Certificate & GCC Market Access
Receive your MDMA certificate (valid 3 years) and leverage SFDA approval for expedited registration across other GCC nations.
Medical Device Sectors in Saudi Arabia
We support SFDA registration across every medical device category and risk class entering the Saudi market.
- 🏥 Cardiovascular Devices
- 🦴 Orthopaedic Implants
- 🔬 In Vitro Diagnostics (IVD)
- 💻 Software as Medical Device (SaMD)
- 🧬 Dental Devices
- 👁 Ophthalmic Devices
- 🩺 Patient Monitoring Systems
- 💉 Drug Delivery Devices
- 🧠 Neurological Devices
- ❤ Wound Care Products
- 🏋 Rehabilitation Equipment
- 💡 AI/ML-Based Medical Devices
- 🩸 Blood Bank Equipment
- 📊 Imaging & Radiology Devices
- 🧪 Laboratory Instruments
- 🛡 Sterilization Equipment
SFDA Registration FAQ
Answers to the most common questions about medical device registration with the Saudi Food and Drug Authority.
What is SFDA MDMA for medical devices?
MDMA (Medical Device Market Authorization) is the current regulatory pathway required by SFDA (Saudi Food and Drug Authority) for all medical devices to be marketed in Saudi Arabia. Since the introduction of MDMA 2 in 2022, it replaced the earlier MDNR notification route. All device classes (A through D) must obtain MDMA certification, which is valid for 3 years and requires prior approval in an accepted reference market (Australia, Canada, EU, Japan, or USA).
How are devices classified by SFDA?
SFDA classifies medical devices into four risk-based classes: Class A (low risk), Class B (low-moderate risk), Class C (moderate-high risk), and Class D (high risk). Classification is determined based on the device’s classification in the reference market (AU, CA, EU, JP, or USA). The classification directly impacts documentation requirements, review timelines, and post-market obligations.
What reference market approvals does SFDA accept?
SFDA accepts prior market approvals from five recognized reference markets: Australia (TGA), Canada (Health Canada), European Union (CE marking under MDR/IVDR), Japan (PMDA), and United States (FDA). Your device must hold valid regulatory approval in at least one of these markets before applying for SFDA MDMA registration in Saudi Arabia.
Do I need an authorized representative in Saudi Arabia?
Yes. All foreign manufacturers seeking to market medical devices in Saudi Arabia must appoint a Saudi Authorized Representative (AR). The AR acts as the legal liaison between the manufacturer and SFDA, handles regulatory submissions, manages post-market surveillance reporting, and ensures ongoing compliance. NexorTest provides authorized representative services for manufacturers worldwide.
How long does SFDA registration take?
The official SFDA review timeline is 35 working days from the date of submission acceptance. However, in practice, the process often takes longer due to queries, documentation requests, or backlog. Including preparation, submission, and review, the entire process typically takes 3 to 6 months. Higher-risk devices (Class C and D) may require additional review time.
What is the cost of SFDA MDMA?
SFDA MDMA registration costs vary depending on the device class, number of variants, and complexity of the submission. Costs include SFDA application fees, authorized representative fees, technical documentation preparation, and potential Arabic labeling/translation costs. Contact NexorTest for a customized quotation based on your specific device and regulatory situation.
What happened to the MDNR procedure?
The MDNR (Medical Device Notification Route) was cancelled by SFDA in September 2022. Previously, MDNR allowed a simplified notification process for lower-risk devices. Following the cancellation, all medical devices regardless of risk class must now go through the full MDMA (Medical Device Market Authorization) process to obtain market access in Saudi Arabia.
Can NexorTest help with GCC-wide registration?
Yes. NexorTest provides comprehensive GCC-wide regulatory support covering Saudi Arabia (SFDA), UAE (MOHAP), Kuwait, Qatar, Bahrain, and Oman. We develop unified regulatory strategies that leverage SFDA approval to facilitate registration across other GCC member states, helping you achieve efficient market access throughout the Gulf region.
Ready to Register Your Device with SFDA?
Get a free regulatory assessment and customized roadmap for your medical device’s entry into the Saudi Arabian and GCC markets.
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