A Technical File Assessment (TFA) is required for market authorization by the Saudi FDA, whereas the SFDA has implemented its own classification system for medical devices. Registration in the Saudi Arabia does not require prior approval in the country of origin, and approval in the reference country is not required for MDMA registration. However, proof of approval in other markets is required for registration.
Through the SFDA's Unified Electronic System, or GHAD, all application documents are submitted electronically. The following documentation must accompany SFDA submissions in English:
The above is an abbreviated summary of information and documents that must be included in the Technical Documentation File submitted for MDMA registration for most devices (In order to submit to the SFDA, medical devices not classified as IVDs, sterile, measuring, reusable surgical instruments, and/or novel must meet abbreviated requirements, as described in MDS-REQ 1.)
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.
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 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.
A Technical File Assessment (TFA) is required for market authorization by the Saudi FDA, whereas the SFDA has implemented its own classification system for medical devices. Registration in the Saudi Arabia does not require prior approval in the country of origin, and approval in the reference country is not required for MDMA registration. However, proof of approval in other markets is required for registration.
Through the SFDA's Unified Electronic System, or GHAD, all application documents are submitted electronically. The following documentation must accompany SFDA submissions in English:
The above is an abbreviated summary of information and documents that must be included in the Technical Documentation File submitted for MDMA registration for most devices (In order to submit to the SFDA, medical devices not classified as IVDs, sterile, measuring, reusable surgical instruments, and/or novel must meet abbreviated requirements, as described in MDS-REQ 1.)
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.
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 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.
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