The registration process for B-class medical devices with the Saudi Food and Drug Authority (SFDA) involves several key steps, from preparing the necessary documentation to submitting your application and obtaining approval. Below is a detailed overview of the process:

1. Pre-Registration Preparations

1.1. Classify the Device as B-Class

• Before proceeding, ensure that your medical device is classified as Class B (moderate risk) according to SFDA's classification system. B-class devices are considered moderate risk and must comply with specific regulatory requirements.

1.2. Appoint a Local Authorized Representative (LAR)

• If your company is based outside Saudi Arabia, you are required to appoint a Local Authorized Representative (LAR) in Saudi Arabia. The LAR will handle the registration process on your behalf, including communication with SFDA.
• The LAR must be SFDA-registered and authorized to submit the application and communicate with SFDA.

1.3. Ensure Compliance with Quality Management System (QMS)

• Ensure your manufacturing facility complies with ISO 13485 (Medical Devices - Quality Management Systems). For foreign manufacturers, the SFDA may require a Good Manufacturing Practice (GMP) certification or an inspection of the manufacturing facility.

2. Account Registration on SFDA Portal

2.1. Create an Account

• Register on the SFDA MDA (Medical Device Affairs) Portal or SDAIA platform. This portal is used for submitting your registration application and tracking the progress of your device’s approval.

2.2. Log in to the Portal

• Once registered, log in to the portal and select “Medical Device Registration” to start the process.

3. Submit the Registration Application

3.1. Fill in Device Information

• Provide detailed information about your medical device, including:
  • Device Name and Description
  • Device Classification (Class B)
  • Intended Use: Describe the purpose and clinical use of the device.
  • Manufacturer Information: Include the name, address, and contact details of the manufacturer.
  • Regulatory Status: If the device is approved in other markets (e.g., EU, USA), provide the corresponding regulatory approvals.

3.2. Submit Required Documentation

The following documents must be prepared and uploaded as part of the application:

• Product Labeling: Submit the device labels in Arabic and English, including the device name, intended use, warnings, and instructions.
• Instructions for Use (IFU): Provide a copy of the IFU in both Arabic and English.
• ISO 13485 Certificate: Provide evidence that the manufacturer’s quality management system complies with ISO 13485.
• Clinical Data: Provide any clinical data that supports the device’s safety and effectiveness (if applicable).
• Risk Management Documentation: Include a risk management file following ISO 14971 guidelines.
• Test Reports: Provide any product testing reports (e.g., electrical safety, biocompatibility, sterility) from recognized laboratories.
• Certificate of Free Sale (CFS): If the device is already marketed in another country, provide a CFS showing the device’s legal sale in that market.

4. SFDA Review Process

4.1. Initial Review

• SFDA will begin by reviewing the submitted documents for completeness and compliance. This includes checking the classification of the device, the quality of documentation, and adherence to SFDA’s regulatory standards.
• If any documents are missing or incomplete, SFDA will request additional information.

4.2. Detailed Evaluation

• The SFDA will perform a detailed evaluation of the following:
  • Device Safety and Effectiveness: Based on the clinical data, performance tests, and risk management documentation.
  • Manufacturer’s Compliance: SFDA may verify that the manufacturer complies with ISO 13485 and GMP.
  • Risk Management: SFDA reviews the device’s risk management approach to ensure all potential risks are identified and mitigated.
  • Labeling and Instructions for Use: The labeling and IFU will be checked for compliance with SFDA’s requirements (including language and content).

4.3. Testing and Inspection (if applicable)

• If necessary, SFDA may request additional product testing (e.g., electrical, mechanical, or biocompatibility testing) or may require an inspection of the manufacturing facility if the device is manufactured outside Saudi Arabia.

5. Registration Decision

5.1. Approval

• If your device meets all SFDA requirements, SFDA will issue a Registration Certificate, and your device will be officially authorized for marketing and distribution in Saudi Arabia.
  • The certificate will include a registration number that must be displayed on the device packaging and labeling.

5.2. Request for Additional Information

• If there are any issues or missing information, SFDA may request additional documents or clarifications. You must submit the required materials promptly to avoid delays.

5.3. Rejection

• If your device does not meet the required regulatory standards, SFDA may reject the application. In such cases, you will need to resolve the issues and resubmit the application.

6. Registration Fees

• Registration Fees: You must pay the applicable registration fees, which vary based on the device type and classification.
• Payment: Once the application is complete, you can pay the registration fee through the SFDA portal.

7. Post-Approval Monitoring and Compliance

7.1. Post-Market Surveillance (PMS)

• Once your device is approved, you must continue to monitor its performance in the market.
  • Submit Periodic Safety Update Reports (PSUR).
  • Report any adverse events or product defects to SFDA.
  • If necessary, take corrective actions, such as issuing field safety corrective actions (FSCA).

7.2. Annual Renewal

• Device registration is valid for one year. You must submit updated documentation and pay renewal fees for annual renewal of the registration.

8. Distribution and Market Launch

• Once you have received approval and the Certificate of Registration, you can begin distributing and marketing the device in Saudi Arabia.

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