To apply for B-class medical device registration with the Saudi Food and Drug Authority (SFDA), follow these step-by-step instructions:

Step 1: Pre-Registration Preparations

1.1. Determine Device Classification

• Ensure that your device falls under Class B according to SFDA regulations. B-class devices are considered moderate risk and have specific requirements for registration.

1.2. Appoint a Local Authorized Representative (LAR)

• If you are a foreign manufacturer, you must appoint a Local Authorized Representative (LAR) in Saudi Arabia. The LAR will act as your liaison with SFDA, handle regulatory submissions, and manage ongoing communications.
• The LAR must be registered with SFDA and be authorized to submit the registration on your behalf.

1.3. Ensure Compliance with Quality Management System (QMS) Standards

• Ensure your manufacturing process complies with ISO 13485 (Medical Devices - Quality Management Systems) or equivalent.
• If your device is manufactured abroad, SFDA may require Good Manufacturing Practice (GMP) certification and may inspect the manufacturing facility.

Step 2: Create an SFDA Account

2.1. Register on the SFDA Portal

• To submit your registration application, create an account on the SFDA Medical Devices Affairs (MDA) portal or SDAIA platform (SFDA’s online registration system).
• You will need to provide basic information about your company, authorized representative, and the device.

2.2. Login to the Portal

• Once registered, log in to the portal and select the Medical Device Registration option.
• Start the B-class device registration process by following the portal's prompts.

Step 3: Submit Registration Application

3.1. Device Information

• Provide detailed information about the device, such as:
  • Device Name and Description: Specify the device’s intended use, purpose, and features.
  • Manufacturer Information: Include details about the manufacturer, including company name, address, and contact information.
  • Classification: Justify why the device is classified as Class B.

3.2. Required Documentation

Prepare the following required documents and upload them through the portal:

• Device Labeling: Submit the labels for the device in both Arabic and English, including the intended use, warnings, and instructions.
• Instructions for Use (IFU): Submit the IFU in Arabic and English.
• ISO 13485 Certification: Submit proof of ISO 13485 certification for the manufacturer’s Quality Management System.
• Clinical Data: Provide any relevant clinical data or safety and performance data supporting the device’s safety and efficacy.
• Risk Management Documentation: Include a risk management file following ISO 14971 guidelines to demonstrate that risks associated with the device have been identified and mitigated.
• Product Testing Data (if applicable): If your device requires safety testing (e.g., electrical safety, biocompatibility), provide test reports from accredited labs.
• Certificate of Free Sale (CFS): If applicable, provide a certificate of free sale from the country of origin to show that the device is legally sold in that market.

Step 4: Review Process by SFDA

4.1. Application Review

• SFDA will begin by reviewing your application for completeness and compliance. They will verify that the device complies with their regulatory requirements and that the device classification is accurate.
• SFDA may request additional information or clarification during this process.

4.2. Testing and Inspection (if applicable)

• If necessary, SFDA may request product testing or an inspection of the manufacturing facility (if the manufacturer is based outside Saudi Arabia) to ensure compliance with GMP and international standards.

4.3. Clinical Data and Risk Assessment Review

• SFDA will review any clinical data provided to assess the safety and effectiveness of the device.
• They will also examine your risk management documentation to ensure risks associated with the device are adequately addressed.

Step 5: Approval and Registration

5.1. Registration Decision

• If your application meets all regulatory requirements, SFDA will issue a Certificate of Registration for your B-class device.
  • This certificate is required for the sale and distribution of the device in Saudi Arabia.
  • SFDA will also assign a registration number to the device, which must be included on the product packaging and labeling.

5.2. Registration Fees

• Pay the applicable registration fees. The fee amount will depend on the type of device and its classification. Make sure to pay promptly to avoid delays in processing.

Step 6: Post-Market Surveillance and Ongoing Compliance

6.1. Post-Market Surveillance (PMS)

• Once your device is on the market, you are required to monitor its safety and effectiveness. This includes reporting any adverse events or product defects to SFDA, conducting field safety corrective actions (FSCA), and submitting Periodic Safety Update Reports (PSUR).

6.2. Annual Renewal

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

Step 7: Distribution and Market Launch

• Once you have received SFDA approval and registration, you can begin distributing and marketing your device in Saudi Arabia.
• Ensure that your device is always compliant with SFDA regulations, including labeling and post-market surveillance requirements.