The update process for A-class medical device registration with the Saudi Food and Drug Authority (SFDA) is essential for ensuring that any changes to the device, its manufacturing, or its market information are communicated and documented properly to maintain compliance with regulatory requirements. This process ensures that your device remains in good standing throughout its lifecycle in the Saudi market.

Here is an overview of the key steps and requirements for updating the registration of an A-class medical device with the SFDA:

1. Identify the Need for an Update

An update to the registration is necessary when there are significant changes to the medical device or its related information. The most common reasons for updates include:

• Changes in the Device Design or Specifications: Any modification to the design, composition, functionality, or materials of the device.
• Changes in Indications for Use: If the intended use, indications, or intended patient population change.
• Manufacturer or Supplier Information: Changes in the manufacturer, supplier, or local authorized representative.
• Manufacturing Process: Modifications to the manufacturing process, including quality control or testing methods.
• Labeling Updates: Modifications to the device label, packaging, or Instructions for Use (IFU), such as language changes (e.g., Arabic translation), regulatory symbols, or product information.
• Changes in Regulatory Status: Any change in the regulatory approval status, such as the introduction of new certifications like CE marking or ISO certifications.
• Clinical Data: If new clinical data is generated that affects the safety or efficacy of the device.

In these cases, an update is required to maintain regulatory compliance.

2. Notify SFDA of Changes

Once a change or update is identified, you need to notify the Saudi Food and Drug Authority (SFDA). The process generally involves the following steps:

• Prepare the Required Documentation: Gather all relevant supporting documentation regarding the change. This could include updated technical files, risk management documentation, quality control records, revised labeling, or updated clinical data.

  Key documents might include:

  • Updated Product Description or Technical File.
  • Risk Management file (e.g., updated according to ISO 14971).
  • New Clinical Data (if applicable).
  • Revised Instructions for Use (IFU) and Labeling (including Arabic translation).
  • Manufacturing and Quality Control Records (if applicable).

• Submit an Update Application through the SFDA Portal: Log into the SFDA’s Medical Device Registration System (MDRS) and submit the updated information. Ensure that you follow the platform’s requirements for document formatting, document size, and any other relevant guidelines.

• Change Classification (if applicable): If the update leads to a change in the risk classification of the device (e.g., from A-class to B-class), you may need to resubmit the device for reclassification and approval.

3. Review and Evaluation by SFDA

After submission, the SFDA will review the updated information to assess whether the changes are in compliance with Saudi regulations.

• Evaluation of New Documentation: SFDA will assess the updated technical documents, labeling, manufacturing processes, and any other information provided.
• Additional Information or Clarifications: SFDA may request additional documentation or clarifications regarding the update. It’s important to respond promptly to avoid delays.
• Review of Risk Assessment: If applicable, SFDA will review the updated risk assessment and evaluate whether the changes have any implications on the device's safety and performance.

4. Approval of Update

Once the SFDA evaluates the updated submission and is satisfied with the provided information, the following may occur:

• Approval or Acknowledgment of Changes: SFDA will issue an approval for the changes made to the device registration, and the updated details will be reflected in the official Medical Device Registration Certificate.

  • New Registration Certificate: You may receive a new registration certificate reflecting the changes made.
  • Documentation Update: SFDA will update the registration status of the device on the Saudi Drug and Food Information Center (SDI) portal, which is accessible by the public.

• Revised Labeling and Packaging: If changes have been made to the labeling or packaging, you may need to update the stock and ensure that only the new version of the device is distributed in the Saudi market.

5. Update the Medical Device Establishment License (MDEL)

If the change involves changes to the local authorized representative or the manufacturer’s information, you will need to update the Medical Device Establishment License (MDEL).

• MDEL Update Process: The local authorized representative must notify the SFDA of the changes in the MDEL to maintain an active license for the device distribution.
• MDEL Renewal: Ensure that your MDEL is up-to-date, especially if the changes require renewal of the license or additional documentation.

6. Post-Approval Monitoring and Reporting

Once the update is approved, it is important to continue complying with ongoing regulatory requirements:

• Monitoring of Post-Market Safety: Continue with post-market surveillance activities, including reporting adverse events or device defects, even after the update.
• Periodic Safety Update Reports (PSUR): Submit updated reports if required, based on the nature of the update (e.g., new clinical data or updated risk information).
• Compliance with New Labeling and Packaging: Ensure that the updated labeling and packaging are used in all devices distributed within Saudi Arabia. This includes ensuring that the Arabic labeling is accurate and compliant with SFDA’s standards.

7. Ensure Timely Renewal of Registration

As your A-class device registration is valid for 5 years, it is crucial to ensure that any changes made to the device are reflected during the renewal process. Timely renewal ensures that your device continues to meet SFDA’s requirements and remains in good standing.

• Device Registration Renewal: Initiate the renewal process before the registration expiration date.
• Re-submit Updated Documentation: When renewing, you may need to resubmit the updated technical documentation, labeling, or manufacturing information to reflect any changes made during the device’s lifecycle.

8. Responding to SFDA’s Requests

After the initial application or updates, SFDA may request further clarifications, data, or modifications.

• Respond to SFDA’s Queries: If SFDA issues a query regarding your update, respond promptly with the necessary clarification or additional documentation.
• Monitor SFDA’s Communication: Keep a close eye on notifications from the SFDA portal to ensure you do not miss any important updates or requests.

Summary of the A-Class Medical Device Update Process with SFDA:

1. Identify the Need for Update: Recognize if changes in design, manufacturer, labeling, or regulatory status require an update.
2. Prepare Documentation: Gather updated documents, including technical files, clinical data, labeling, and risk management documents.
3. Submit Update: Submit the updated documentation via the SFDA’s MDRS portal.
4. SFDA Review: SFDA evaluates the changes and may request additional information or clarification.
5. Approval: SFDA approves the update, issues an updated registration certificate, and updates the registration status.
6. MDEL Update: Ensure that any changes to the local representative or distributor are reflected in the MDEL.
7. Post-Approval Monitoring: Continue post-market surveillance and reporting activities as required.
8. Registration Renewal: Ensure the device registration is renewed every 5 years, reflecting any updates made.

By following this process, you can ensure that your A-class medical device registration with SFDA remains valid and compliant with Saudi regulations, ensuring the safety and efficacy of the device in the market. Let me know if you need more details about any part of the process!

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