Medical Device Registration in Saudi Arabia for Brazilian Manufacturers
Seamless SFDA Approval with Trusted Regulatory Experts
Are you a Brazilian medical device manufacturer planning to expand into the Middle East? To legally place your devices on the Saudi market, you must comply with the Saudi Food and Drug Authority (SFDA) medical device regulations. This process requires precise documentation, local representation, and strict adherence to safety and quality standards. At Operon Strategist, we provide end-to-end consulting support to help Brazilian manufacturers achieve SFDA approval quickly and efficiently, ensuring smooth access to one of the fastest-growing healthcare markets in the region.
Why SFDA Registration is Essential
The Saudi Food and Drug Authority (SFDA) regulates all medical and in vitro diagnostic (IVD) devices imported or sold in the Kingdom. Without SFDA approval, manufacturers cannot legally market or distribute their devices in Saudi Arabia. Key reasons why SFDA registration is critical for Brazilian exporters:
- Legal Market Entry – Mandatory approval to sell devices in Saudi Arabia.
- Market Growth – Access to one of the largest healthcare markets in the Middle East.
- International Recognition – Enhances product credibility and compliance image.
- Partnership Opportunities – Increases trust among Saudi distributors and healthcare providers.
SFDA Medical Device Registration Process
We guide Brazilian manufacturers through each stage of the Saudi medical device registration process, including:
Classification of Medical Devices – Determining risk category according to SFDA rules.
Appointment of Local Authorized Representative (LAR) – Required for all foreign manufacturers.
Preparation of Technical Documentation – Aligning with SFDA guidance and GHTF standards.
Submission to SFDA – Filing applications via the Medical Device Marketing Authorization (MDMA) system.
Review & Approval – Managing queries, addressing compliance gaps, and ensuring timely approval.
Post-Market Surveillance (PMS) – Assisting with vigilance reporting, renewals, and compliance maintenance.
SFDA Registration Documents List
To register your medical device in Saudi Arabia, you must prepare and submit the following documents to the Saudi Food and Drug Authority (SFDA):
- SFDA Application Form
- Authorized Representative Details/License
- Complete Technical File (including risk analysis, clinical evaluation, and labeling)
- Conformity Assessment Report
- Medical Device Marketing Authorization (MDMA) Certificate
Who Needs SFDA Approval?
SFDA approval is mandatory for all organizations involved in the manufacturing, importing, or distribution of medical devices and IVD products in Saudi Arabia. This includes:
- Medical Device Manufacturers in Brazil aiming to export products to Saudi Arabia
- IVD Manufacturers of diagnostic kits, reagents, and instruments
- Importers and Distributors handling international medical devices within the Kingdom
- Local Authorized Representatives (LARs) acting on behalf of global manufacturers
Get Expert Support for SFDA Approval – Talk to Our Consultants Today!
How Operon Strategist Supports Brazilian Manufacturers
Our consulting services are designed to reduce delays and increase approval success rates:
- Regulatory Strategy Development – Customized roadmap for SFDA approval.
- Technical Documentation Support – Guidance on dossiers, labeling, and quality certifications.
- Local Representation – Support in appointing a reliable Saudi Authorized Representative.
- End-to-End Project Management – From initial classification to final approval.
- Post-Approval Compliance – Assistance with renewals, vigilance, and regulatory updates.
Why Choose Us for SFDA Approval?
- 15+ years of global regulatory consulting expertise.
- Specialized in Middle East market entry for medical devices & IVDs.
- Strong track record of successful SFDA registrations.
- Dedicated support for Brazilian exporters entering Saudi Arabia.
FAQs
What is SFDA approval and why is it required?
SFDA approval is the authorization granted by the Saudi Food and Drug Authority (SFDA) to medical devices and IVD products. It is mandatory for manufacturers, importers, and distributors to ensure their products meet Saudi Arabia’s safety and quality standards. Without SFDA approval, medical devices cannot be legally marketed in Saudi Arabia.
How long does the medical device registration process in Saudi Arabia take?
The timeline varies depending on the device classification and completeness of documentation. On average, the SFDA registration process may take 3–6 months for Class A and B devices, and longer for higher-risk Class C and D devices.
What documents are required for SFDA registration?
SFDA Application Form
Authorized Representative License/Details
Complete Technical File
Conformity Assessment Report
Medical Device Marketing Authorization (MDMA) Certificate
Who needs to obtain SFDA approval in Saudi Arabia?
Any company involved in the manufacturing, importing, or distributing of medical devices or IVDs in Saudi Arabia must obtain SFDA approval. This includes international manufacturers (such as those from Brazil), local distributors, and authorized representatives.
Can foreign manufacturers apply for SFDA registration directly?
No, foreign manufacturers must appoint a Local Authorized Representative (LAR) in Saudi Arabia. The LAR acts as the official liaison with SFDA and manages the registration process on behalf of the manufacturer.