Requirements for Registering Medical Devices with the Food and Drug Authority.

To register a medical device with the Food and Drug Authority, several requirements and procedures must be followed according to the Saudi Food and Drug Authority (SFDA), which oversees this process. Here are some essential steps and key requirements:

• Obtain a Facility License: For import and distribution.     

•Classify the Device to be Registered:

The classification of the medical device must be determined based on the associated risk level.     •Complete the Registration Application Form:

(Notification of Marketing) for the product.     

•Documentation and Approvals: 

You may need to present approvals such as CE Marking or FDA approval, depending on the device classification.     

•Electronic Registration: 

The device must be registered through the Medical Device National Registry (MDNR) system of the Food and Drug Authority.     

•Submit Required Documents: 

A set of documents such as quality certificates, clinical studies, and technical reports supporting the safety and efficacy of the device is required.     

•     Local Agent:

A local agent must handle the registration process and communication with the Food and Drug Authority.     

•Inspection and Evaluation:

Medical devices may be subject to inspections and evaluations by the authority to ensure compliance with the required standards.     

•Regular Follow-Up: 

After approval of the registration, you must maintain quality and safety requirements and make necessary updates for approvals or changes that may occur to the device.     

•Registration Fees: 

There are specific fees for registering medical devices depending on the device classification and type of registration:     

•     Category One = 15,000 SAR     

•     Category Two A = 19,000 SAR     

•     Category Two B = 21,000 SAR     

•     Categories Three and Four = 23,000 SAR

These are some basic steps for registering a medical device. It is advisable to contact the Food and Drug Authority directly at 19999 or consult our specialized advisors for complete details and assistance in registering your products.