Medical Device Registration in Saudi Arabia for Brazilian Manufacturers
Expert SFDA Approval Consulting for Brazilian Medical Device Manufacturers
Are you a Brazilian medical device or IVD manufacturer planning to expand into Saudi Arabia? To legally market medical devices in the Kingdom, obtaining SFDA approval is mandatory. Operon Strategist provides end-to-end consulting for SFDA approval and medical device registration, helping you secure Medical Device Marketing Authorization (MDMA) efficiently, reduce regulatory risk, and ensure full compliance with SFDA requirements.
Why SFDA Registration is Essential for Brazilian Manufacturers
The Saudi Food and Drug Authority (SFDA) regulates all medical devices and in vitro diagnostic (IVD) products imported, distributed, or sold in Saudi Arabia. Without SFDA approval, devices cannot be legally marketed in the Kingdom.
Key Benefits of SFDA Approval
- Legal Market Entry – Mandatory authorization to sell in Saudi Arabia
- Access to the Largest GCC Healthcare Market
- Enhanced Global Regulatory Credibility
- Increased Trust with Saudi Distributors & Hospitals
- Gateway to Broader Middle East Markets
SFDA Medical Device Registration & Approval Process
We guide Brazilian manufacturers through the complete SFDA approval process:
1. Device Classification
Determine the risk class (A, B, C, or D) according to SFDA regulations
2. Appointment of Local Authorized Representative (LAR)
- Mandatory Saudi-based LAR to liaise with SFDA
- Handles communication, submissions, and follow-ups
3. Technical Documentation Preparation
- Full technical file aligned with SFDA, GHTF, IMDRF, and ISO 13485 standards
- Includes risk management, clinical evaluation, labeling, and IFU review
4. MDMA Application Submission
- Filing through the SFDA Medical Device National Registry (MDNR)
- Leverage prior FDA, CE Marking, or ANVISA approvals if available
5. SFDA Review & Query Management
- Addressing SFDA deficiency letters and queries promptly
- Corrective actions to prevent delays or rejections
6. Post-Approval Compliance
- Issuance of MDMA certificate
- Ongoing vigilance reporting, renewals, and compliance updates
SFDA Approval Documents Checklist
Required documents for SFDA submission include:
- SFDA Medical Device Application Form
- Local Authorized Representative (LAR) License & Agreement
- Complete Technical File
- Risk Management & Clinical Evaluation Reports
- Conformity Assessment / Free Sale Certificate
- ISO 13485 Certificate
- Labeling & Instructions for Use (IFU)
- Medical Device Marketing Authorization (MDMA)
Who Needs SFDA Approval?
SFDA approval is mandatory for:
- Brazilian Medical Device Manufacturers exporting to Saudi Arabia
- IVD Manufacturers producing kits, reagents, and analyzers
- Saudi Importers & Distributors of international medical devices
- Local Authorized Representatives (LARs) representing foreign manufacturers
Ideal Clients for Our SFDA Approval Services
Best suited for: ✔ Brazilian manufacturers with FDA, CE, or ANVISA-approved devices ✔ Companies entering the Saudi market within 6–12 months ✔ Manufacturers seeking partnerships with Saudi distributors
Not suited for: ✖ Concept-stage or prototype-only devices ✖ Manufacturers without complete technical documentation ✖ Companies not ready to appoint a Saudi LAR
How Operon Strategist Ensures Successful SFDA Approval
Our services are tailored to increase SFDA approval success rates and reduce timelines:
- Regulatory strategy & device classification
- Technical file and dossier preparation
- Labeling and IFU compliance review
- Local Authorized Representative (LAR) support
- Complete MDMA application management
- Post-approval vigilance, renewals, and compliance updates
Get Your SFDA Approval Started – Free Expert Eligibility Assessment
Why Choose Operon Strategist for SFDA Approval?
FAQs
What is SFDA approval?
SFDA approval is the authorization from the Saudi Food and Drug Authority allowing medical devices and IVDs to be legally marketed in Saudi Arabia.
How long does SFDA medical device registration take?
Class A & B devices: approximately 3–6 months
Class C & D devices: longer depending on device complexity
Can Brazilian manufacturers apply for SFDA approval directly?
No. Foreign manufacturers must appoint a Saudi Local Authorized Representative (LAR) to submit and manage the application.
Does SFDA recognize FDA, CE, or ANVISA approvals?
Yes. These approvals can support the SFDA application, but SFDA conducts its own independent review.