B-Class Medical Device Registration with Saudi SFDA

In Saudi Arabia, the Saudi Food and Drug Authority (SFDA) regulates medical devices to ensure their safety and effectiveness. The SFDA classifies medical devices into four classes (A, B, C, and D) based on the level of risk they present to patients and users.

A B-class medical device typically refers to a device that is considered to present a moderate risk to users. B-class devices are more complex than Class A devices, but they do not involve the same high-risk factors as Class C or D devices. These devices may include items like diagnostic equipment, therapeutic devices, surgical instruments, and monitoring equipment that do not involve invasive procedures or critical life-support functions.

How to Apply for B-Class Medical Device Registration with SFDA

The process for registering a B-class medical device with the SFDA is as follows:

Step 1: Device Classification

• Verify the classification: Ensure your device is correctly classified as Class B according to SFDA’s device classification guidelines. This is typically based on the level of risk, the intended use of the device, and the nature of its interaction with the human body.
  • SFDA’s guidelines provide detailed information on what constitutes each class, so ensure your device matches the criteria for Class B.

Step 2: Appoint an Authorized Representative (if necessary)

• If your company is not based in Saudi Arabia, you are required to appoint a local authorized representative in Saudi Arabia. The representative will serve as the point of contact between your company and SFDA, handling the regulatory submission and any communication on your behalf.

Step 3: Prepare the Required Documentation

You will need to prepare various documents to support your application. These typically include:

1. Device Description: Provide a detailed description of the device, including its intended use, technical specifications, and intended patient population.
2. Risk Management: Submit a Risk Management File for the device that follows international standards (such as ISO 14971), outlining the potential risks associated with the device and the mitigation measures.
3. Conformity Assessment: Submit evidence that the device meets applicable international regulatory requirements, such as:
   • CE Marking (for European markets)
   • FDA Approval (for the U.S. market)
   • Alternatively, evidence of conformity to other international standards may be submitted.
4. Clinical Data: If available, provide clinical data or studies demonstrating the device's safety and performance.
5. Quality Management System (QMS): You will need to demonstrate compliance with a QMS such as ISO 13485 to show that your manufacturing processes meet international quality standards.
6. Labeling and Instructions for Use (IFU): Provide the device’s labeling, including all required information in Arabic and/or English as per SFDA’s guidelines.
7. Manufacturing Site Information: Provide details about the manufacturing site and the regulatory status of the manufacturer.
8. Declaration of Free Sale: If available, include a Declaration of Free Sale or a similar document from the device's country of origin, confirming that the device is legally marketed there.

Step 4: Online Registration via SFDA’s MDES System

• SFDA uses the Medical Device Electronic System (MDES) for online registration.
• To submit your application, create an account in the MDES portal and upload all the required documentation.
• During the submission, you will be required to pay a registration fee, which varies depending on the type of device and the level of review needed.

Step 5: SFDA Evaluation

• Once the application is submitted, the SFDA will evaluate your device registration application. This may involve a review of the device’s safety and effectiveness, as well as its compliance with regulatory requirements.
• If there are any missing documents or additional information required, SFDA will request clarifications or further details from you.

Step 6: Issuance of Registration Certificate

• If the SFDA is satisfied with your application, they will issue a registration certificate for your device, allowing it to be marketed and sold in Saudi Arabia.
• This registration will be valid for a specific period (usually 5 years), after which you will need to re-register or renew your device's registration.

Step 7: Post-Market Surveillance

• After registration, you must comply with post-market surveillance requirements, which include reporting adverse events, complaints, and any other safety or effectiveness issues related to your device.
• SFDA also requires periodic updates or renewals of the device’s registration, and you must maintain compliance with Saudi regulatory requirements at all times.

Key Considerations

• Language Requirements: Ensure that all labeling and documentation, including instructions for use (IFU), are provided in both Arabic and English, as required by SFDA.
• Regulatory Fees: Make sure you are aware of the registration fees and any other associated costs. Fees can vary depending on the type and complexity of the device.
• Inspection and Audits: While not always required for B-class devices, SFDA may conduct inspections or audits of the manufacturer’s facilities to ensure compliance with quality and regulatory standards.

Important Tips

• Prepare Early: The registration process can take several months, so it’s important to start early to avoid delays.
• Consult an Expert: If you’re unfamiliar with the regulatory process, consider consulting with a regulatory affairs expert or local representative who has experience navigating the SFDA’s registration process.

Would you like more detailed information on any of these steps, or assistance with preparing your documentation?

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