SFDA Certification for Medical Devices in the USA

Looking to tap into the booming Saudi Arabian healthcare market? SFDA certification is the key to unlocking regulatory approval for medical devices in the Kingdom of Saudi Arabia. For U.S. startups aiming to expand globally, securing Medical Device Marketing Authorization (MDMA) is essential—but navigating SFDA’s complex requirements can be challenging without the right partner. That’s where Operon Strategist steps in.

What is SFDA Certification?

SFDA Certification refers to regulatory approval from the Saudi Food and Drug Authority (SFDA) required to legally market medical devices and in-vitro diagnostics (IVDs) in the Kingdom of Saudi Arabia (KSA). The process involves obtaining a Medical Device Marketing Authorization (MDMA), which verifies that a device complies with all SFDA safety, quality, and performance standards.

Is SFDA Certification Required for US-Based Manufacturers?

Yes. US-based medical device manufacturers must obtain MDMA approval to sell or distribute devices in Saudi Arabia. Additionally, companies without a physical presence in KSA are required to appoint a Saudi Authorized Representative (AR) to interact with SFDA on their behalf.

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SFDA Medical Device Registration Process (Step-by-Step)

Appoint a Saudi Authorized Representative (AR): A licensed AR is required to serve as the regulatory liaison between the manufacturer and SFDA.
Conduct a Gap Analysis: Evaluate the existing technical documentation against SFDA’s regulatory requirements to identify missing data, such as clinical evaluations or risk assessments.
Prepare the Technical File: Include product description, design dossier, labeling, testing reports, and conformity assessment documents.
Submit the MDMA Application: Applications must be submitted by qualified regulatory professionals. Improper submissions are typically rejected without detailed feedback.
Receive MDMA Approval: Once approved, the manufacturer may legally ship and distribute the device in Saudi Arabia under SFDA compliance.

Required Documents for SFDA Certification

SFDA Application Form
Authorized Representative License
Full Technical File
Conformity Assessment Reports
Existing Regulatory Certifications (e.g., CE Mark, ISO 13485)

SFDA Certification Timeline

The standard SFDA review period for MDMA is approximately 35 business days, assuming the documentation is complete and compliant. Approval is valid for three years unless otherwise stated.

How Operon Strategist Assists US Medical Device Startups

Operon Strategist offers end-to-end regulatory consulting for SFDA certification, tailored to startups and SMEs in the U.S. medical device industry. Services include: