To apply for B-class medical device registration with the Saudi Food and Drug Authority (SFDA), you must go through the Medical Device Electronic System (MDES), which is the official platform for registering medical devices in Saudi Arabia. Below is a step-by-step guide on how to apply for B-class medical device registration, where to apply, and the general process:

Where to Apply

You must submit your application through the Medical Device Electronic System (MDES), which is available on the official SFDA portal. The MDES portal allows you to apply for medical device registration, track the status of your application, and receive approval notifications.

• Website: MDES Portal - SFDA

If you are an international manufacturer, you will need a local authorized representative in Saudi Arabia to submit the application on your behalf.

Steps to Apply for B-Class Medical Device Registration with Saudi SFDA

1. Create an Account on the MDES Portal

• Step: First, you need to create an account on the MDES portal. If you do not have an account yet, you must register with the platform.
  • Website: MDES Portal - SFDA
  • This portal allows you to access all the tools needed to apply for medical device registration and manage your application.
  • Ensure that you provide accurate details during the account registration process.

2. Appoint a Local Authorized Representative (for Non-Saudi Manufacturers)

• If your company is based outside Saudi Arabia, you must appoint a local authorized representative (LAR) in Saudi Arabia.
  • The LAR will act as your liaison with the SFDA and be responsible for submitting the registration on your behalf.
  • Ensure the representative is registered with the SFDA and authorized to submit and manage applications.

3. Classify Your Device

• Ensure that your device is correctly classified as a B-class medical device.
  • B-class devices are typically considered moderate risk devices.
  • You may need to provide supporting documentation to justify the classification of your device.
  • SFDA follows its own classification rules based on device risk levels and intended use, so ensure your device matches the appropriate class.

4. Submit Application via MDES Portal

• Step: Once logged in to the MDES portal, navigate to the Medical Device Registration section.
  • Select B-class as the classification for your device.
  • Fill in the required details about your medical device, including its name, model, intended use, and manufacturer.
  • You will be asked to submit various documents, including the device description, risk management documentation, quality management system certifications (e.g., ISO 13485), clinical data (if applicable), labeling, and instructions for use (IFU).

5. Prepare and Upload Required Documents

You need to upload the following documents as part of your application:

1. Device Description and Classification: Detailed description of the device, its intended use, and clinical indications.
2. Risk Management Documentation: A risk analysis report following ISO 14971 (if applicable).
3. Conformity Assessment: ISO 13485 certification (or equivalent) to demonstrate that your manufacturing process adheres to quality standards.
4. Clinical Data (if applicable): Any clinical data or clinical evaluation reports that demonstrate the safety and effectiveness of the device.
5. Labeling: Include labeling in both Arabic and English, covering essential information such as warnings, instructions, and intended use.
6. Instructions for Use (IFU): Submit the IFU in both Arabic and English.
7. Manufacturing Site Information: Include details of the manufacturing facility and compliance with Good Manufacturing Practices (GMP).
8. Certificate of Free Sale (DFS): If applicable, provide a DFS from the country of origin, confirming that the device is legally sold there.

6. Pay the Registration Fees

• Once the application is submitted and all documents are uploaded, you will be prompted to pay the registration fees.
  • The fees are typically paid through the MDES portal using available online payment options (e.g., credit card or bank transfer).
  • Make sure you pay the correct fees based on the device classification and type of submission.

7. Track the Application Status

• After submission, you can track the status of your application in the MDES portal.
  • SFDA may request additional information or clarification. Ensure that you respond promptly to any SFDA inquiries to avoid delays.
  • If SFDA finds no issues with the submitted documents, they will proceed with the review.

8. SFDA Review and Approval

• SFDA will review your application and may request a technical review or a site inspection (if needed).
  • Once the review is completed and the device meets all regulatory requirements, SFDA will issue a registration certificate.
  • After obtaining registration approval, you can legally market and distribute the B-class medical device in Saudi Arabia.

Important Notes to Consider

• Local Authorized Representative (LAR): If your company is outside Saudi Arabia, appointing an LAR is mandatory. The LAR will manage the entire registration process on your behalf and liaise with SFDA.

• Document Language: Ensure that labeling, IFU, and other key documents are in both Arabic and English. While some documents can be in English, SFDA generally requires these key documents to be in Arabic for local compliance.

• Compliance with Standards: SFDA places a strong emphasis on quality and safety. Make sure that your device complies with international standards such as ISO 13485 for quality management and ISO 14971 for risk management.

• Post-Market Surveillance: After your device is registered, you will be required to comply with post-market surveillance requirements, including reporting adverse events, recalls, and any changes to the device or its manufacturing process.