To apply for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), you'll need to follow a structured process. The registration process involves a number of steps, including preparing and submitting relevant documentation, ensuring compliance with SFDA regulations, and going through the review process. Here is a step-by-step guide to apply for D-class medical device registration with the Saudi SFDA:

Step-by-Step Process for Applying for D-Class Medical Device Registration with the SFDA

1. Determine Device Classification

• Check Device Classification: Ensure that your device qualifies as a D-class (low-risk) medical device. D-class devices typically include those that are non-invasive and present minimal risk to patients or users. You can refer to the SFDA's Medical Device Classification Guidelines to verify the classification of your device.
• Documentation: Make sure that the device classification is clearly mentioned in the device description.

2. Appoint a Saudi Local Authorized Representative (LAR)

• LAR Requirement: If the device manufacturer is located outside Saudi Arabia, they must appoint a Local Authorized Representative (LAR) who is based in Saudi Arabia. The LAR will be responsible for submitting the registration application on behalf of the manufacturer and maintaining communication with the SFDA.
• LAR Responsibilities:
  • Submit the registration application and manage the documentation.
  • Communicate with the SFDA during the review process.
  • Handle any post-market regulatory issues, such as adverse event reporting and device recalls.

3. Gather Required Documentation

The following documents are required for D-class medical device registration with the SFDA:

• Device Description: A clear description of the device, including its intended use, classification, and indications for use.
• Manufacturer Information: Company name, address, and contact details of the manufacturer. If the device is imported, the LAR must provide their details.
• Quality Management System (QMS) Certification: A copy of the ISO 13485 certification or an equivalent certification indicating compliance with Good Manufacturing Practices (GMP).
• Risk Management Documentation: A risk management file in line with ISO 14971, demonstrating the device's safety and effectiveness.
• Labeling and Packaging: Copies of the device labeling, including the Instructions for Use (IFU), packaging labels, and any safety or cautionary statements. These must be in both Arabic and English.
• Clinical Data (if applicable): For some devices, clinical data might be required to demonstrate safety and performance, though D-class devices usually require less clinical data than higher-risk devices.
• Free Sale Certificate (if applicable): A certificate from the manufacturer stating that the device is legally sold and marketed in the manufacturer's country.
• Declaration of Conformity (if applicable): A declaration confirming that the device meets the applicable regulatory standards.

Ensure that all documentation is complete, accurate, and in the required format, as incomplete or inaccurate submissions can delay the approval process.

4. Submit the Application via SDRS (Saudi Drug Registration System)

• Create an Account: The application must be submitted through the Saudi Drug Registration System (SDRS). If you do not already have an account, create one on the SFDA's e-Services portal.
• Login and Application: After logging into the SDRS system, select the medical device registration option. Follow the instructions to fill out the application and upload the required documents.
• Payment of Fees: The application process includes the payment of registration fees, which are dependent on the device type and classification. Ensure you have the payment ready and submit the fee as part of the registration process.
• Submit Application: Once all fields are filled and the necessary documentation is uploaded, submit the application. You will receive a submission confirmation from the SFDA.

5. SFDA Review Process

• Initial Acknowledgment: Once the application is submitted, the SFDA will acknowledge the submission and check the completeness of the documentation. If any documents are missing or unclear, the SFDA will request additional information.
• Technical Review: The SFDA will review the application in detail, focusing on aspects like device safety, efficacy, labeling, and compliance with local regulations.
• Request for Additional Information (if necessary): If the SFDA finds any gaps in the application or requires more details, they will request further documentation or clarification from the applicant.

6. SFDA Decision

• After completing the review process, the SFDA will make a decision regarding the registration:
  • Approval: If the application meets all regulatory requirements, the SFDA will approve the device and issue a registration certificate. This allows the device to be marketed and sold in Saudi Arabia.
  • Request for Further Clarification: If the SFDA needs more information or modifications, they will inform the applicant and provide a timeline for submission.
  • Rejection: If the device fails to meet the SFDA’s requirements, the application may be rejected. The applicant can then address the issues and reapply.

7. Issuance of Registration Certificate

• Certificate Issuance: If the registration is approved, the SFDA will issue a registration certificate for the device. This certificate will include the registration number and expiration date, confirming the device’s legal status in Saudi Arabia.
• Product Listing: The device will also be listed in the SFDA’s database, and the registration status will be publicly available.

8. Post-Market Surveillance and Compliance

• Post-Market Surveillance (PMS): After the device is registered, the manufacturer and the Local Authorized Representative (LAR) must comply with the SFDA’s post-market surveillance requirements. This includes reporting any adverse events, device malfunctions, or other safety concerns to the SFDA.
• Annual Renewal: D-class medical devices are subject to annual renewal of their registration. The manufacturer or LAR must submit updated documents and pay the required renewal fees.

9. Annual Registration Renewal

• Renewal Process: The device registration is valid for a year, and manufacturers must submit a renewal application each year to maintain their device’s legal status in Saudi Arabia.
• Updated Documentation: During the renewal process, manufacturers may need to provide updated information regarding the device’s performance, changes to labeling, or any new safety data.

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