SFDA Medical Device Registration Services
Get SFDA Approval. Start Selling in Saudi Arabia.
Unlock growth in one of the Middle East’s largest healthcare markets with expert regulatory support. We help medical device manufacturers and distributors obtain SFDA Medical Device Marketing Authorization (MDMA) quickly and compliantly — from submission to approval.
Why You Need SFDA Registration
To legally market medical devices and in-vitro diagnostics (IVDs) in the Kingdom of Saudi Arabia, you must secure SFDA approval (MDMA) — a mandatory regulatory authorization ensuring safety, quality, and performance.
✔ Sell your product across all healthcare channels
✔ Comply with Saudi regulatory standards
✔ Streamline approval with professional support
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Fill the Form or Mail Us to: enquiry@operonstrategist.com
Our SFDA Registration Services
Important Note: When it comes to the right design of the facility, the man and material flow are to be taken into consideration. The product segregation, product manufacturing flows and process steps, the use of the classified areas plays the important role. The good experience handholding will lead to the correct decision makings of the same.
We provide end-to-end regulatory expertise for your medical device or IVD:
1. Regulatory Strategy & Classification
Get precise classification based on SFDA requirements — essential for approval timelines and documentation scope.
2. Technical File Preparation
We prepare and optimize your technical dossier for SFDA submission, minimizing risks of rejection or resubmission.
3. Local Authorized Representative Support
Foreign manufacturers must appoint a Saudi Authorized Representative to liaise with SFDA — we facilitate this process for you.
4. MDMA Submission & Follow-Up
From portal submission to responding to SFDA inquiries, we manage the full application process.
5. QMS & Compliance Guidance
We assist with ISO 13485 QMS compliance — a critical element of SFDA expectations.
Fast, Reliable Approval
With a well-prepared submission, most SFDA MDMA approvals are processed in approximately 30–60 days — saving you time and accelerating market access.
Benefits of Working With Us
- Reduce regulatory burden and avoid costly delays
- Improve approval success rates with expert regulatory support
- Stay compliant with evolving SFDA requirements
- Focus on your product while we handle SFDA submission and follow-ups
Trusted SFDA Registration Experts for Medical Devices
Why Choose Operon Strategist?
Operon Strategist is a trusted regulatory consulting partner for medical device manufacturers worldwide. Our team combines deep SFDA regulatory expertise with hands-on submission experience to deliver faster, smoother approvals. We focus on accuracy, compliance, and transparency—minimizing rejections, reducing timelines, and protecting your market entry. With a proven track record, clear communication, and end-to-end support, we don’t just submit applications—we help you succeed in the Saudi market.