To apply for B-class medical device registration with the Saudi Food and Drug Authority (SFDA), you'll need to follow a structured process. Here are the steps typically involved:

1. Determine the Classification of Your Device

• B-class medical devices are generally those that present a moderate risk to patients and users. These can include devices like syringes, diagnostic devices, or therapeutic equipment.
• It's essential to correctly classify your device to ensure the proper regulatory pathway. If unsure, you can consult the SFDA's classification guidelines or seek expert advice.

2. Establish a Saudi Authorized Representative (if applicable)

• If your company is not based in Saudi Arabia, you will need to appoint a local authorized representative who will act as your point of contact with the SFDA and handle regulatory matters.

3. Prepare the Required Documentation

The SFDA typically requires the following documents for B-class medical device registration:

• Device Description and Intended Use: A clear description of the device and its intended medical purpose.
• Risk Management File: A risk assessment according to ISO 14971 or equivalent standards.
• Quality Management System (QMS) Certification: Proof of a quality management system (e.g., ISO 13485 certification).
• Conformity Assessment: Declaration of conformity with relevant international standards (e.g., CE mark, FDA approval, or others depending on your market).
• Labeling: A copy of the device labeling and Instructions for Use (IFU) in Arabic and/or English, as per SFDA requirements.
• Clinical Data: If applicable, clinical data or evidence of the device’s performance and safety.
• Packaging Information: Details about the packaging and sterile packaging (if applicable).
• Manufacturing Site Information: Details about the manufacturer, including their quality assurance and regulatory status.
• Declaration of Free Sale (if applicable): A document from the home country authority confirming the device is legally sold in the country of origin.

4. Submit the Application Online

• SFDA uses the Saudi Medical Devices Electronic Registration System (MDES) for online submission.
• You will need to create an account on the MDES portal and submit your registration application along with the necessary documents.
• During the submission, you will pay any relevant application fees as per SFDA’s fee structure.

5. Review and Evaluation

• After submission, the SFDA will review your application and may request additional information or clarifications. This review can take several weeks.
• If the device requires additional scrutiny or clinical trials data, this will be requested during this phase.

6. Inspection and Audits (if applicable)

• SFDA may conduct a facility inspection (if the manufacturer is located in Saudi Arabia or if they deem it necessary) to verify compliance with regulatory standards, such as ISO 13485.
• In some cases, an audit may also be required to verify the manufacturing and quality systems.

7. Issuance of Registration Certificate

• Once the review is complete and the SFDA is satisfied with the documentation and compliance, they will issue a registration certificate for your device.
• The device will then be authorized for sale in Saudi Arabia, and you will be included in the SFDA’s approved medical device database.

8. Post-market Surveillance

• After registration, you must comply with post-market surveillance and reporting requirements, which may include adverse event reporting and periodic updates to the SFDA regarding the device's safety and performance.

Important Tips:

• Language: Make sure that the documentation, especially the IFU, labeling, and other important information, are provided in both Arabic and English, as the SFDA requires these languages for registration.
• Timely Updates: Ensure that you are up-to-date with any changes in SFDA regulations and requirements.
• Authorized Representative: If you don't have a local representative, consider appointing one, as it’s often a critical part of the registration process.

Would you like more specific details about any step, or assistance with documentation requirements?

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