Your Trusted Regulatory Partner for Success in Saudi Arabia
Engaging with SFDA
Flexible regulatory terms, tailored regulatory intelligence, and local representation in Saudi for seamless compliance and market access
OMC Medical Saudi Arabia – Your Gateway to Regulatory Success
At OMC Medical, we specialize in helping medical device manufacturers navigate Saudi Arabia’s stringent regulatory framework. With expertise in SFDA registration, GCC compliance, and market access, we ensure a seamless approval process for your products. Whether you need support with product classification, local representation, quality assurance, clinical evaluation, or post-market surveillance, our dedicated team in Saudi Arabia provides comprehensive regulatory solutions. Trust OMC Medical to help you achieve compliance and successfully enter the growing Saudi healthcare market
OMC Benefits
- SFDA Expertise – End-to-end support for medical device registration and compliance.
- Local Representation – Act as your Saudi Authorized Representative for regulatory approvals.
- GCC Compliance – Ensure seamless market entry across Saudi Arabia and the GCC region.
- Faster Market Access – Streamlined documentation and submission process.
- Regulatory Guidance – Expert advice on classification, clinical evaluation, and quality assurance.
- Post-Market Surveillance – Continuous support for vigilance, reporting, and compliance updates
Discover tailored solutions across pharmaceuticals, life sciences, consumer goods, and more. Our expertise spans diverse industries, ensuring compliance and excellence. Explore innovative strategies and services to elevate your business in the competitive market
Saudi Arabia’s medical device and IVD market is strictly regulated by the SFDA, requiring full compliance for market approval. OMC Medical simplifies this process by providing expert assistance in SFDA registration, local representation, supplier audits, QMS implementation, process validation, and regulatory documentation. Our services ensure smooth market entry, ongoing compliance, and a strong competitive position in Saudi Arabia’s growing healthcare sector
Saudi Arabia’s cosmetics market is regulated by the SFDA, requiring strict compliance for product registration, safety assessments, and labeling. OMC Medical streamlines this process by offering expert guidance in SFDA approvals, local representation, supplier audits, and ongoing compliance management. We help brands navigate Saudi Arabia’s evolving cosmetic regulations, ensuring seamless market entry and long-term success.
Saudi Arabia’s pharmaceutical market is regulated by the SFDA, requiring strict compliance for drug registration, clinical trials, quality control, and post-market surveillance. OMC Medical simplifies this process by providing expert support in SFDA approvals, local representation, GMP compliance, supplier audits, and regulatory documentation. We help pharmaceutical companies navigate Saudi Arabia’s evolving regulatory landscape, ensuring smooth market entry and sustained compliance.
OMC Medical provides expert support for businesses seeking market entry in Saudi Arabia by acting as an Authorized Representative and ensuring compliance with SFDA regulations. We assist with regulatory submissions, appointing a local Representative, and managing communications with Saudi authorities. Our expertise in Saudi Arabia’s evolving regulatory landscape ensures a smooth approval process, enabling seamless market access for medical devices, pharmaceuticals, and cosmetics. With OMC Medical, you gain a trusted partner to navigate complex compliance requirements efficiently
OMC Medical provides expert translation services tailored to Saudi Arabia’s regulatory landscape, ensuring compliance with SFDA requirements. As an ISO 17100:2015 certified provider, we specialize in accurate translations of medical, pharmaceutical, and clinical documents, including IFUs, user manuals, and legal texts. Our services help businesses navigate regulatory approvals and facilitate seamless market entry in Saudi Arabia
Saudi Medical Device Registration & SFDA Approval
Saudi Arabia’s medical device market is one of the fastest-growing in the Middle East, offering immense opportunities for manufacturers looking to expand in the region. However, before selling medical devices in Saudi Arabia, obtaining regulatory approval from the Saudi Food and Drug Authority (SFDA) is mandatory
Why is Saudi Arabia a Key Market for Medical Devices?
Saudi Arabia is the largest and most populous country in the Gulf Cooperation Council (GCC), with over 37 million people. Its healthcare sector is rapidly expanding, driven by:
- Population Growth: An aging and growing population increases demand for advanced medical devices.
- Healthcare Investments: The government prioritizes healthcare development under its Vision 2030 plan.
- Consumer Awareness: People are adopting modern medical solutions to improve their quality of life.
The market is projected to grow significantly, making it an ideal destination for manufacturers looking to expand.
What is GHAD System?
The SFDA has switched to an electronic system for document submission, called GHAD System. Local and Foreign manufacturers, via an AR, should submit their application electronically in the GHAD System
The manufacturer shall prepare a Technical Documentation, comply with and confirm the Essential Principles of Safety and Performance and maintain an effective Quality Management System (QMS).
About OMC
OMC Medical is a leading regulatory consulting firm specializing in global market access for medical devices, IVDs, pharmaceuticals, and cosmetics. With expertise in SFDA regulations, we assist businesses in navigating Saudi Arabia’s complex compliance landscape, including product registration, quality assurance, local representation, and regulatory intelligence. Our tailored solutions ensure smooth approvals and seamless market entry, making OMC Medical a trusted partner for regulatory success in Saudi Arabia
We are a global firm and we have local expertise across the following countries.
Europe
Asia
Africa
Oceania
South America
North America
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Expand Your Medical Device Business in Saudi Arabia with SFDA Compliance
- SFDA Experts with proven success in Saudi Arabia Medical Device Registration
- Faster Approvals with our streamlined SFDA Registration process
- Comprehensive Support for all Medical Device Companies in Saudi Arabia
✅ 100% Compliance | Affordable Pricing | Fast-Track Approvals
Why SFDA Registration is Crucial for Medical Device Companies in Saudi Arabia?
- Saudi Arabia's Booming Medical Market – Don’t Miss Out
- Strict SFDA Regulations – Ensure Compliance for Hassle-Free Market Entry
- Complex Registration Process? We Make it Simple & Fast
Who Needs SFDA Registration?
- Medical Device Manufacturers (Global & Local)
- Distributors & Importers
- Healthcare Companies Expanding to Saudi Arabia
SFDA Medical Device Classification & Registration Process
Medical Device Classification in Saudi Arabia (SFDA Guidelines)
Step-by-Step SFDA Medical Device Registration Process
- Determine Device Classification (A, B, C, D)
- Appoint a Local Authorized Representative
- Prepare SFDA-Compliant Documentation
- Submit Application & Technical File
- Undergo SFDA Review & Approval Process
- Receive SFDA Medical Device Market Authorization (MDMA)
- Sell & Distribute in Saudi Arabia Legally
The SFDA oversees the regulation of medical devices and IVDs in Saudi Arabia. Its guidelines align closely with the European Union’s Medical Device Regulation (MDR), which simplifies registration for manufacturers already compliant with EU standards. However, there are Saudi-specific requirements that need attention.
Step 1: Appoint a Local Authorized Representative
Foreign manufacturers must designate a Local Authorized Representative (LAR) to handle SFDA compliance, application submission, and post-market surveillance. The LAR must:
✔ Comply with SFDA.MD/GSO ISO 13485
✔ Have a physical presence in Saudi Arabia
✔ Hold a separate establishment license
Step 2: Classify Your Medical Device
Devices must be classified based on their risk level:
🔹 Class A – Low risk (e.g., reusable surgical instruments)
🔹 Class B, C, D – Increasing risk levels (e.g., implants, life-support devices)
Accurate classification ensures a smooth approval process and prevents unnecessary delays.
Step 3: Prepare Technical Documentation
Manufacturers must provide essential documents, including:
📌 Device specifications & intended use
📌 Instructions for Use (IFU) & labeling requirements
📌 Risk management & post-market surveillance plans
📌 Additional clinical studies & testing data for higher-risk devices
Step 4: Register & Apply via GHAD System
The GHAD online portal is used for:
🖥 Device & company registration under SFDA regulations
📄 MDMA application submission with required documentation
💰 Payment of applicable fees and tracking application progress
Step 5: Address SFDA Queries & Pay Fees
SFDA may request further details, such as:
✅ Risk analysis & safety reports
✅ Clinical evaluation for Class C & D devices
✅ Manufacturing & quality assurance documentation
Timely responses prevent delays in approval. Fees vary based on device classification.
Step 6: Obtain SFDA Medical Device Approval
After successful review, SFDA issues the MDMA certificate, which includes:
📌 Manufacturer & device details
📌 National listing number & classification
📌 Authorized intended use in Saudi Arabia
The certificate is valid for one year and must be renewed for continued market access. 🚀
Getting difficulty in approval? Must Consult us
Registration Application (With Company Stamp)
Authorized Representative Agreement
Technical File
(SFDA-Approved Format)
Conformity
Assessment Report
Medical Device Market Authorization (MDMA) Certificate
Post-Market
Surveillance Plan
Post-Market Surveillance
- Post Market Surveillance Report is required to be submitted by manufacturers of Class A devices. This report should be generated when necessary or when requested by the SFDA. Manufacturers of Class B, C and D devices should generate a Periodic Safety Update Report (PSUR).
- A PSUR should be generated annually for Class C and D devices and once every two years for Class B devices. Class D and Implantable devices should produce Summary of Safety and Clinical Performance documentation.
- The SFDA also accepts electronic Instructions for Use (e-IFU). The manufacturers should provide adequate risk assessment documentation related to the e-IFU. The risk assessment should be updated in conjunction with the post-marketing activities.
- For devices with a fixed expiry date, the e-IFU should be maintained for at least two years after the end of the expiry date of the last produced device. For devices with no expiry, the e-IFU should be maintained for 15 years after the previous device has been manufactured
Why Compliance is Key to Success?
Saudi Arabia medical device registration process can be complex, but understanding the process ensures a smoother path to approval. By meeting SFDA requirements and leveraging local expertise, manufacturers can confidently expand into this thriving market.
Product
Registration
Authorized Representative
Product
Classification
Technical
Document
Quality
Assurance
Initial Submission Review:
30-60 Days
Technical Documentation Review:
60-120 Days
Final SFDA Approval:
3-6 Months
License Validity:
3 Years
Why Choose OMC Medical for SFDA Registration??
- Fast-Track Approvals – We Reduce Registration Time
- Expert Regulatory Team – Hassle-Free Compliance
- Affordable Pricing – Best Rates for Small & Large Enterprises
- Comprehensive Support – From Submission to Post-Market Compliance
Frequently Asked Questions (FAQ)
Still Have Questions? Contact Us Now for a Free Consultation
You must register your product under SFDA guidelines, classify it, and submit technical documentation for approval.
It varies by device class, typically 3-6 months.
Yes, foreign manufacturers must appoint a local authorized representative to manage the registration process.
SFDA requires Arabic labeling with product details, manufacturer info, and compliance markings.
Still Have Questions? Contact Us Now for a Free Consultation