Frequently Asked Questions

What documents are needed for Saudi FDA Registration for Medical Devices?

Saudi Food and Drug Authority (SFDA) requires a complete technical file for the medical device consisting mainly of the product's detailed description, design & manufacturing process, verification & validation of essential principles of safety and performance, risk management, quality management system, and post-market surveillance.

What is required to be eligible to start the registration process for Medical Devices with the Saudi Food and Drug Authority (SFDA)?

Overseas manufacturers are required to appoint an Authorized Representative (AR) to be able to apply for their medical device registration.
‍Local manufacturers are required to obtain a medical device manufacturing license from the Saudi FDA to apply for registration.

How long is Saudi FDA registration valid, and when can it be renewed?

The registration license Medical Device Marketing Authorization (MDMA) is valid for 3 years and it can be renewed every three years.

When can we start the renewal process of the Medical Device Marketing Authorization (MDMA) license?

You can initiate the renewal process with the Saudi FDA 90 days before the expiry date of the license.

How many distributors can we have?

There is no limit to the number of distributors that can market the product after obtaining the MDMA license.

How does the Saudi FDA classify the risk of Medical Devices?

Saudi FDA has identified 22 rules for Medical Devices and 7 rules for Invitro Diagnostic devices (IVDs) in MDS-G008 to determine the risk class of the products.
It is mainly depending on the duration of use and how far the product is invasive to the human body.

What are the fees for Saudi FDA registration of Medical Devices?

The Saudi FDA registration fee is based on the risk classification of the product as illustrated in the below table.

Class A	SAR 15,000 (≈USD 4,225.35)
Class B	SAR 19,000 (≈USD 5,352)
Class C	SAR 21,000 (≈USD 5,915.5)
Class D	SAR 23,000 (≈USD 6,478.87)

Can we change the Authorized Representative (AR)? will it affect the registration documents?

The legal manufacturer has the right to change the AR or appoint a new AR. This will have no impact on the registered products as long as there is no ongoing registration.

Can we have more than one Authorized Representative (AR)?

Yes. However, not for the same product.

Is the Low-risk devices Registration pathway still available?

No, this registration route was closed by the Saudi FDA on the 27th of September 2022.

Who can market the Medical Device after registration?

Any Saudi FDA-licensed distributor can market the device in the Saudi market.

Is it a must for the distributor to be our Authorized Representative (AR)?

Distributors within categories C and D have the option to either obtain the ISO 13485 certificate or get audited by the Saudi FDA on an annual basis to ensure full compliance with ISO 13485 requirements.

Is the CE / FDA required for medical device registration with the Saudi FDA?

No. However, they can be provided as supportive evidence during the registration process.

Is it mandatory for the local distributors to hold the ISO 13485 certificate?

Yes, local distributors within categories A and B are mandated to obtain an ISO 13485 certificate from an SFDA or IAF-accredited certification body.

How many items can be included in one MDMA certificate? And is there a specific consideration for that?

Every MDMA application can have no more than 50 trade names registered with the condition that it shall comply with the SFDA bundling criteria according to Annex (15) of MDS-REQ01.