How to Register a Medical Device with SFDA (MDMA) — A Complete Guide for 2026
Author: Motaded Limited Team | Last updated: June 2026 | Reading time: 8 minutes
Saudi Arabia's medical device market is among the fastest-growing in the Middle East, driven by Vision 2030 and the Kingdom's healthcare sector strategy. However, before any local or importing company can sell a medical device in the Saudi market, MDMA (Medical Device Marketing Authorization) must be obtained from the Saudi Food and Drug Authority (SFDA). This guide explains in detail the registration mechanism, the four device classes, fees per class, requirements, and the common mistakes that cause rejection.
Important note: This guide covers product registration (MDMA), not establishment licensing (MDEL). For complete information on medical device establishment licensing, visit the SFDA platform page on Motaded.
What is MDMA Registration? And Why is it Mandatory?
MDMA (Medical Device Marketing Authorization) is the official authorization issued by SFDA for every medical device or medical product before it enters the Saudi market. This includes:
• Diagnostic medical devices: X-ray machines, blood test devices, blood pressure monitors, ultrasound devices.
• Therapeutic medical devices: Resuscitation equipment, ventilators, medical lasers, physiotherapy devices.
• Medical supplies: Catheters, needles, bandages, syringes, blood bags.
• Active Implantable Medical Devices (AIMD): Pacemakers, artificial valves, prosthetic joints.
• In Vitro Diagnostic devices (IVD): Laboratory specimen testing tools.
• Medical optics products: Medical lenses, vision testing devices.
Without MDMA registration, no warehouse, hospital, pharmacy, or e-commerce platform in Saudi Arabia is permitted to store or sell the device. Violations include immediate confiscation, financial penalties, and establishment license revocation.
The Four Medical Device Classes per SFDA Classification
SFDA classifies medical devices into four classes based on the level of risk to the patient. Each class has different documentation requirements and fees:
| Class | Risk Description | Examples | Registration Fee |
| Class I | Low risk | Medical adhesives, wheelchairs, simple bandages, exempt IVD | SAR 15,000 |
| Class II/IIa | Medium risk | Thermometers, blood pressure monitors, self-test IVD | SAR 19,000 |
| Class IIb/III | High risk | Ultrasound devices, X-ray machines, Annex II List B IVD | SAR 21,000 |
| Class III/IV/AIMD | Highest risk — implantable | Pacemakers, artificial valves, Annex II List A IVD | SAR 23,000 |
All fees exclude VAT 15%. Renewal of registration for any class is SAR 5,000, and minor updates of labels and instructions for use is SAR 1,100.
MDMA Registration Steps: From Start to Finish
Step 1: Determine the Device Class
Before any procedure, the medical device class must be determined precisely. Classification depends on the degree of bodily penetration, duration of use, type of interaction with the human body, and the level of risk in case of malfunction. Wrong classification means request rejection and loss of fees. When in doubt, a product classification request can be submitted to the Authority at SAR 1,000.
Step 2: Appoint the Authorized Representative (for foreign companies)
Foreign companies without a legal entity in Saudi Arabia must appoint an Authorized Representative (AR) resident in the Kingdom, licensed by SFDA. The AR license costs SAR 2,600 annually for 1 to 10 years. The AR is legally responsible for the device in the Saudi market. Motaded provides an integrated AR service for foreign companies, including preparation of the certified AR agreement and signing on behalf of the parent company.
Step 3: Prepare the Technical File
The technical file is the administrative and technical heart of the request. SFDA rejects any incomplete file without refunding fees. The file includes:
• CE certificate (for devices approved in the European Union) or FDA certificate (for US devices) or equivalent from internationally accredited bodies.
• GMP certificate or ISO 13485:2016 for quality management system for medical devices.
• Device technical report: technical specifications, engineering drawings, safety and efficiency tests.
• Clinical studies if any (for Class III and IV).
• Device labels and user manual in Arabic and English.
• Free Sale Certificate from the country of origin, attested by the Saudi embassy.
• Authorized Representative agreement (for imported devices).
Step 4: Electronic Application Submission
Submission is done through the SFDA Medical Devices Registration System. All documents must be uploaded in PDF format, with mandatory fields completed regarding tracking, storage, transportation, and handling within the establishment.
Step 5: Pay the Fees
After technical acceptance of the request, the system issues an invoice from the Operations Sector Billing System. Payment is done through the SADAD system using Biller Number 109 for the Saudi Food and Drug Authority. Details of the multiple payment systems are explained on the comprehensive SFDA platform.
Step 6: Technical Review and Inspection
Specialized reviewers from SFDA study the file and may request clarifications or additional documents. For Class III and IV, on-site inspection of the device manufacturer (locally or internationally) is required to verify GMP compliance. International GMP inspection fees range from SAR 33,000 (for Saudi Arabia) to SAR 184,000 (for manufacturers in Australia and New Zealand).
Step 7: MDMA Certificate Issuance
After passing review and inspection, SFDA issues the MDMA certificate for a 5-year renewable period. The device becomes listed in the approved devices list on the Authority's website, and distributors and hospitals are entitled to approve and contract for it.
Common Mistakes That Cause MDMA Request Rejection
• Classifying the device in the wrong class (e.g., applying as Class II for a device that is actually Class III).
• Expired certificates (CE/FDA/ISO) or those not attested by the Saudi embassy.
• Inaccurate translation of labels and user manuals into Arabic.
• Quality management system not updated to ISO 13485:2016 (old versions are rejected).
• Authorized Representative agreement not properly attested by the concerned bodies.
• Incomplete technical file: missing engineering drawings, safety test reports, or clinical studies.
• Failure to answer the electronic system's questions on tracking, storage, transportation, and handling.
Post-Registration Obligations: What Comes After MDMA?
MDMA registration is not the end of the journey, but its beginning. Ongoing obligations include:
• Reporting incidents and adverse events: Any incident related to the device (injury, malfunction, complaint) must be reported to SFDA within the specified period.
• Sales documentation: Every device sold must be tracked through a system that ensures it can be recalled when necessary.
• Notifying the Authority of any changes: Change in device design, brand name, manufacturer address, or addition of a new product to the family. Major update fees SAR 5,000.
• Renewing the license before expiration: MDMA renewal fee is SAR 5,000.
• Post-Market Surveillance: Monitoring device performance and collecting data from users.
How Motaded Limited Helps with MDMA Registration
We have assisted 281 establishments in registration and compliance with the Saudi Food and Drug Authority, and our regulatory team includes medical device specialists. Our complete services in this field include: precise device classification, technical file preparation, official label translation, AR agreement issuance and attestation, electronic submission, follow-up with SFDA until approval, on-site inspection management, and periodic renewal follow-up. Discover the complete package on the SFDA platform page or book a meeting with a Motaded expert now to discuss your device specifically.
Foreign Companies: Do I Need a Saudi Partner?
No, foreign companies can register with SFDA at 100% ownership after obtaining an investment license from the Ministry of Investment (MISA). The options available for foreign companies are: (a) establishing a fully Saudi legal entity and registering directly; (b) appointing a Saudi Authorized Representative (at SAR 2,600/year) and keeping the legal entity abroad. Option (b) is faster and cheaper, but does not allow direct distribution — sales must be through a licensed Saudi distributor.
Conclusion
Medical device registration with SFDA is a complex and costly procedure, but a necessary investment to access the Saudi market valued at billions of riyals. The four classes have different requirements and fees, and common mistakes in the technical file cost significant time and money. Motaded Limited provides an integrated MDMA registration service with a 96% success rate on the first attempt. Book your free consultation now to evaluate your device and determine the class, fees, and timeline.
Question 1: How long do MDMA registration procedures take?
Answer: Duration typically ranges from 60 to 180 business days depending on the device class and the technical file readiness. Class I and II are faster (60-90 days), while Class III and IV take longer due to on-site inspection (120-180 days). Motaded shortens this duration by 30-40% thanks to preparing a complete file on the first attempt.
Question 2: Is MDMA registration sufficient for selling in GCC countries?
Answer: No, each Gulf country has its own regulatory authority, but SFDA has mutual recognition agreements that facilitate registration in other Gulf countries. A device registered in SFDA enjoys faster acceptance in the UAE, Kuwait, and Qatar compared to unregistered devices.
Question 3: What is the difference between MDMA and MDEL?
Answer: MDMA (Medical Device Marketing Authorization) is the registration of the product/device itself. MDEL (Medical Device Establishment License) is the establishment license (factory/warehouse/importer/distributor). Any company dealing with medical devices needs both: an establishment license + a registration for each product it handles.
Question 4: Can I register a used or refurbished medical device?
Answer: Yes, but with additional requirements including a certificate from the manufacturer that the device has been refurbished according to its standards, a technical inspection report, and a new warranty. SFDA deals with refurbished devices very cautiously and may require additional tests.
Question 5: Are requirements different for digital medical devices and AI?
Answer: Yes, software-based medical devices (SaMD) and AI have additional requirements including: documentation of decision-making algorithms, software update plan, cybersecurity testing, and data validation studies. SFDA issued a special guide for these devices in 2023.
Question 6: What happens if an MDMA request is rejected?
Answer: In case of rejection, SFDA sends a notification with the rejection reasons. Re-submission is possible after correcting the reasons, but without refunding the fees paid in the first request. This is the biggest reason why preparing a complete file from the first attempt is essential.