Saudi Arabia Authorized Representative

Ensure smooth entry into the Saudi Arabian medical device market with a licensed in-country representative who understands SFDA requirements and safeguards your compliance.

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Saudi Arabia Medical Device Registration

To sell a medical device in The Kingdom of Saudi Arabia (KSA), you must register it with the Saudi Food and Drug Authority (SFDA) and obtain a Medical Devices Marketing Authorization (MDMA). SFDA revised its regulatory requirements in 2021 to further align with classification rules and technical file requirements in the EU Medical Devices Regulation (EU MDR 2017/745). SFDA is known for its meticulous review of MDMA applications and manufacturers must be vigilant about adhering to SFDA’s unique requirements.

Manufacturers without a legal entity in Saudi Arabia must also designate an in-country representative, known as a Saudi Arabia Authorized Representative. An AR for Saudi Arabia is a regulatory obligation as well as a key player in the registration process and throughout the product lifecycle.

What is a Saudi Arabia Authorized Representative?

Your Saudi Arabia Authorized Representative is a person or company operating in the KSA that acts as your liaison with the SFDA. The AR plays a critical role in the marketing and distribution of your device and should have expertise in SFDA’s device registration and post-market compliance requirements.

As your Saudi Arabia Authorized Representative, we will:

Handle proper preparation and submission of all required documentation to the SDFA for Medical Device Market Authorization (MDMA) and company registration.
Report device modifications, adverse events, and all other vigilance items to maintain post-market compliance throughout the lifecycle of your device.
Submit renewals for your device registration according to its regulatory approval route.

Who can act as a Saudi Arabia Authorized Representative?

Your Saudi Arabia Authorized Representative can be an individual or company, but they must be located in Saudi Arabia. They must also maintain a license issued by the SFDA that must be renewed annually. You can only have one AR for Saudi Arabia per device group or category, but you can designate the same AR for multiple device groups or categories. In other words, the same AR can represent your full device portfolio.

Ideally, your AR should be an independent provider specializing in representation activities and regulatory affairs. A distributor can act as your Saudi Arabia Authorized Representative, but this arrangement can complicate distribution agreements and potentially compromise your regulatory compliance in the long term. A distributor might resist adding or changing distributors to your registration. They might also lack the designated resources and expertise to report an incident or a non-compliance on time, particularly if it occurred in the distribution system.

MedEnvoy is your trusted Saudi Arabia Authorized Representative

MedEnvoy partners with a trusted local partner, to provide our clients with in-country representation in Saudi Arabia. Our experienced team in Riyadh ensures your entry to the Saudi Arabian medical device market is seamless.

How we can help:

Technical file preparation and submission

We prepare your registration submission and technical file, along with all necessary documentation, to ensure it meets SFDA requirements. We will submit your registration to SFDA and liaise with them throughout the review process to fulfill any requests for further information with efficiency.

Labeling authorization and review

You will have authorization to place our partner’s trade name and address as your AR on your labeling, packaging, Instructions for Use (IFU), and technical documentation. We review your labeling to ensure it conforms to SFDA’s labeling requirements.

Liaise with the SFDA

We will handle all communication with SFDA regarding your registration and post-market compliance. We will retain copies of your technical documentation and CE Certification, if applicable, and provide them to SFDA for review, only if requested.

FAQs

Is it mandatory to appoint an Authorized Representative in Saudi Arabia?

Yes. If you do not have a legal entity in Saudi Arabia, you must appoint a local Authorized Representative to register your medical devices with the SFDA and maintain regulatory compliance.

Can a distributor act as my Saudi Arabia Authorized Representative?

Yes, but it’s not recommended. Using a distributor as your AR can create conflicts of interest, limit flexibility when changing distributors, and compromise your regulatory standing if they lack the required expertise and responsiveness.

How many Authorized Representatives can I appoint in Saudi Arabia?

You can appoint only one Authorized Representative per device group or category. However, a single AR can represent multiple device groups, allowing you to consolidate your portfolio under one representative.

What kind of documentation is required for SFDA registration?

Required documents include a technical file, CE Certificate (if applicable), labeling, Instructions for Use (IFU), Certificate of Free Sale, Manufacturer’s Declaration of Conformity, and company registration documents. Your AR ensures these are properly submitted and formatted.

Does the AR appear on device labeling and packaging?

Yes. The AR’s name, address, and contact details must be included on your labeling, packaging, and IFU in accordance with SFDA regulations.

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