To register and apply for Class C medical device registration with the Saudi Food and Drug Authority (SFDA), you need to follow a structured process that involves online application, submission of required documents, and compliance with SFDA guidelines. Here’s a step-by-step guide to help you navigate the registration process:

Steps to Register for Class C Medical Device with SFDA

Step 1: Pre-Registration Preparations

1. Appoint an Authorized Representative (if applicable):

   • Foreign Manufacturers must appoint a local authorized representative in Saudi Arabia to handle the registration and regulatory communication with the SFDA.
   • The authorized representative must be a legal entity in Saudi Arabia with access to SFDA's eServices portal.

2. Ensure Compliance with SFDA Guidelines:

   • The medical device must comply with international standards such as ISO 13485 (Quality Management Systems), ISO 14971 (Risk Management), ISO 10993 (Biocompatibility testing), and IEC 60601 (Electrical safety, if applicable).

3. Gather Required Documentation: Prepare the following documents for submission:

   • Device Description and Classification: Detailed description of the device, including intended use, model, and classification (Class C).
   • Risk Management Plan: Based on ISO 14971, outlining the risk assessment and mitigation strategies.
   • Clinical Data: If applicable, provide clinical trial data or scientific evidence showing safety and efficacy.
   • Manufacturing Site Certification: A Good Manufacturing Practice (GMP) certificate issued by a recognized authority (FDA, EMA, etc.).
   • Product Labeling and Instructions for Use (IFU): Labeling in both Arabic and English as per SFDA regulations.
   • Biocompatibility Testing Results: If the device is in direct contact with the human body, provide evidence of testing as per ISO 10993.
   • Other Regulatory Approvals: Include certificates like CE Marking or FDA approval if applicable.

4. Prepare for SFDA Inspection (if required):

   • SFDA may inspect the manufacturing facility, especially if it is located outside Saudi Arabia. Ensure that the facility meets Good Manufacturing Practice (GMP) standards.

Step 2: Create an Account on SFDA eServices Portal

1. Register on the SFDA eServices Portal:

   • Go to the SFDA eServices portal: SFDA eServices Portal
   • Create an account if you do not already have one. The authorized representative (if applicable) must create an account and manage the registration submission process.

2. Link the Device Profile:

   • Link the medical device and manufacturer’s profile on the portal, ensuring that permissions are granted to the authorized representative.

Step 3: Complete the Online Application Form

1. Fill Out the Application Form:

   • Log in to the SFDA portal and select the Medical Device Registration option.
   • Complete the online application form by providing detailed information about the device, including:
     • Device name, model, and classification (ensure it is classified as Class C).
     • Manufacturer and authorized representative details.
     • Device intended use, risk classification, and regulatory status.

2. Upload Required Documents:

   • Upload all supporting documents, including:
     • Risk Management Plan (ISO 14971).
     • Clinical Data (if applicable).
     • Manufacturing Site GMP Certification.
     • Biocompatibility Test Results (if applicable).
     • Product Labeling and Instructions for Use (IFU).
     • Regulatory Certifications (CE Mark, FDA approval, etc.).

3. Payment of Fees:

   • Pay the required registration fee through the SFDA eServices portal. The fee will vary depending on the device type and complexity.

Step 4: SFDA Review Process

1. Document Review:

   • The SFDA will review the submitted documents to ensure they comply with regulatory requirements. This may take several weeks depending on the complexity of the device.

2. Additional Information Request:

   • If the SFDA finds any discrepancies or requires additional information, they will request clarification or further documentation. Prompt responses to these requests are essential to avoid delays.

3. Manufacturing Facility Inspection (if applicable):

   • If the device is manufactured outside Saudi Arabia, SFDA may conduct an inspection of the manufacturing facility to verify Good Manufacturing Practice (GMP) compliance.
   • If the manufacturing facility already holds certification from a recognized authority (e.g., FDA, EMA), this may expedite the process.

Step 5: Approval or Rejection

1. Approval:

   • If the application meets all SFDA requirements, the device will be approved and the registration certificate will be issued. The device will be authorized for sale in Saudi Arabia.
   • The registration certificate is typically valid for five years.

2. Rejection:

   • If the application is not in compliance with SFDA requirements, the registration may be rejected. The SFDA will provide feedback on the reasons for rejection, and the applicant can address the issues and resubmit the application.

Step 6: Post-Approval Requirements

1. Post-Market Surveillance:

   • After the device is approved, the authorized representative or manufacturer must conduct post-market surveillance to monitor the device’s safety and effectiveness in the market.
   • Adverse event reporting: Report any serious incidents or adverse events to SFDA within 15 days of occurrence.

2. Periodic Safety Update Reports (PSUR):

   • If applicable, submit Periodic Safety Update Reports (PSUR) to SFDA to keep them informed about the device’s safety profile.

3. Renewal of Registration:

   • The registration certificate is valid for five years. The manufacturer or authorized representative must apply for renewal before the certificate expires. Renewal may involve submitting updated documentation and paying a renewal fee.

Summary of Steps to Register a Class C Medical Device with the SFDA

1. Pre-Application Preparations:

   • Appoint an authorized representative (if applicable), ensure ISO 13485 compliance, and gather required documentation (risk management, clinical data, GMP certificate, etc.).

2. Create Account on SFDA Portal:

   • Register on SFDA eServices portal and link the device profile to the manufacturer’s account.

3. Complete the Online Application:

   • Fill out the application form, upload required documents (clinical data, GMP certificate, etc.), and pay the registration fee.

4. SFDA Review Process:

   • SFDA reviews the application and documents, may conduct a facility inspection (if applicable), and evaluates the technical data.

5. Approval or Rejection:

   • Await SFDA’s decision. If approved, receive the registration certificate.

6. Post-Approval Compliance:

   • Implement post-market surveillance, report adverse events, and submit Periodic Safety Update Reports (PSUR) if required.

7. Renew Registration:

   • Apply for renewal before the registration certificate expires (typically after five years).

By following these steps and ensuring all required documents are accurately prepared and submitted, you can successfully apply for and register a Class C medical device with the Saudi Food and Drug Authority (SFDA).