SFDA Medical Device Registration

CMC Medical Devices offers medical Device Registration in Saudi Arabia

We facilitate global registration in Saudi Arabia, ensuring regulatory compliance and efficient legal representation for your entry into the Saudi market.

Authorized Representative in KSA

You must also appoint an authorized representative in Saudi Arabia if you do not have an office or entity in Saudi Arabia.

Your Authorized Representative (AR) must obtain an Authorized Representative License, which is renewable annually, to legally represent you in KSA.

Your KSA authorized representative is also responsible for submitting all application documents to the SFDA to register your device. The SFDA assigns an official review period of 35 business days for applications; however, actual review times are often longer, especially if additional information is requested.

The recently established Saudi route by the SFDA requires a Technical File Assessment (TFA) for market authorization, and the SFDA has implemented its own classification system for medical devices.

Prior approval in the country of origin is not a prerequisite for registration in KSA, and reference country approval is not required for MDMA registration; however, any proof of existing approvals in other markets is requested as part of the registration documentation.

CMC can assist you in entering the Arab market by registering your products with the SFDA.

Select CMC as your GHAD SFDA

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Frequently asked questions about saudi arabia medical device regulations

Is SFDA registration mandatory for all medical devices?

Yes, all medical devices, regardless of their risk classification, must be registered with the SFDA before they can be legally marketed or distributed in Saudi Arabia.

Who can act as my Local Authorized Representative (LAR)?

Any Saudi-based entity or individual can act as your LAR, provided they are qualified and authorized to communicate with the SFDA on behalf of your company. The LAR handles submissions, communications, and ensures compliance with SFDA regulations.

How long does the SFDA registration process take?

The time frame can vary depending on the complexity of the device and the completeness of the submitted documentation. On average, the process can take several months, typically between 3 to 6 months, but it can be longer for high-risk devices.

What happens if I don’t register my medical device with the SFDA?

If you fail to register your device, you will not be able to market, distribute, or sell it in Saudi Arabia. Additionally, selling unregistered devices can result in legal penalties, product recalls, and fines.

Why appoint CMC Medical Devices as your GHAD SFDA?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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