D-Class Medical Device SFDA Registration Process and Steps in Saudi Arabia

Registering a D-class medical device with the Saudi Food and Drug Authority (SFDA) involves a detailed process because D-class devices are considered high-risk devices. These devices require rigorous evaluation to ensure patient safety. Below is the step-by-step process for registering a D-class medical device in Saudi Arabia.

1. Preliminary Classification Review

• Device Classification: The first step is to confirm that your medical device qualifies as a D-class device. SFDA categorizes medical devices into four classes: A (low risk), B (low-medium risk), C (medium-high risk), and D (high risk). D-class devices typically include implantable devices, life-sustaining devices, or those that pose significant risks to patient health.
• Criteria for D-Class: D-class devices are those with significant potential risk, such as:
  • Implantable devices (e.g., pacemakers).
  • Devices that sustain or support life (e.g., ventilators, dialysis machines).
  • Devices that require close monitoring due to their complexity or risk profile.

2. Appoint a Local Authorized Representative (If Applicable)

• Local Representative Requirement: If the manufacturer is not based in Saudi Arabia, it is mandatory to appoint a local authorized representative (usually a local distributor or regulatory affairs consultant).
• Role of Local Representative: This representative acts as the point of contact with the SFDA and is responsible for ensuring that all regulatory requirements are met and the registration process is carried out efficiently.

3. Prepare the Required Documentation

Preparing and compiling the appropriate documentation is a critical step in the registration process. The following documents are required for D-class medical devices:

• Device Description: A detailed description of the device, its intended use, function, and specifications.
• Risk Management File: A document outlining the risks associated with the device, how they are assessed, and strategies for mitigating them (in accordance with ISO 14971).
• Clinical Evidence: Comprehensive clinical data demonstrating the safety and performance of the device. This is especially crucial for D-class devices and may involve clinical trial data, clinical evaluations, or post-market surveillance data.
• Conformity Assessment: Proof of conformity to international standards (e.g., CE marking, FDA approval). This is important for high-risk devices, as SFDA often accepts evidence from other regulatory authorities.
• ISO 13485 Certification: A valid certificate proving that the manufacturing process adheres to the international standard for medical device quality management systems.
• Technical File/Design Dossier: A detailed technical dossier that includes all design, performance, and safety testing information.
• Manufacturing Site Information: Documentation about the manufacturing process and facilities, which should comply with Good Manufacturing Practice (GMP) standards.

4. Register on the SFDA e-Submission Platform (Mysfda)

• Create an Account: To initiate the registration process, you or your local representative must create an account on the Mysfda platform (SFDA's official portal for device registration).
• Submit the Application: After logging into the platform, complete the medical device registration application form and upload all the required documents.
• Fee Payment: Payment of registration fees is required. Fees vary based on the device's classification and other factors.

5. SFDA Evaluation Process

• Technical Review: Once the application is submitted, SFDA will conduct a detailed review of all documents. This includes the device's risk profile, clinical data, conformity assessments, and any other relevant evidence.
• Inspection and Audit: For high-risk D-class devices, the SFDA may require an on-site inspection of the manufacturing site to verify compliance with Good Manufacturing Practices (GMP) and other relevant regulations.
  • Audit Process: SFDA may audit the production processes, quality control systems, and risk management strategies.
• Additional Information Requests: If necessary, SFDA may request additional data, clarifications, or documentation to support the evaluation.

6. SFDA Decision and Registration Approval

• Approval Notification: If the SFDA is satisfied with the submission, they will grant registration approval. This approval is usually communicated via the Mysfda portal.
• Registration Certificate: Once approved, you will receive an official SFDA registration certificate, which allows you to market and distribute the device in Saudi Arabia.
• Listing of the Device: The device will be listed in the SFDA’s database, and the registration certificate will serve as proof of compliance with Saudi regulatory standards.

7. Post-Market Surveillance and Compliance

• Post-Market Requirements: After the device is registered and marketed in Saudi Arabia, the manufacturer or authorized representative must adhere to SFDA’s post-market surveillance regulations.
  • Adverse Event Reporting: Any adverse events or product complaints must be reported to SFDA in a timely manner.
  • Product Recalls: In case of any safety concerns or defective products, the manufacturer must carry out recalls in accordance with SFDA guidelines.
• Annual Registration Renewal: Medical device registrations in Saudi Arabia must be renewed annually. To renew, you will need to submit updated information and pay renewal fees. SFDA may also require periodic updates or new data, especially if there have been significant changes to the device or its intended use.

8. Registration Renewal

• Annual Renewal: SFDA requires annual renewal of medical device registration. This renewal involves submitting updated information, paying the applicable fees, and ensuring ongoing compliance with Saudi regulations.
• Updated Documentation: If there are any changes to the device (e.g., manufacturing processes, labeling), these must be updated in the SFDA system during renewal.

Key Considerations for D-Class Medical Device Registration:

• Clinical Data is Crucial: D-class devices require extensive clinical data, including pre-market clinical trials or post-market surveillance data, to prove their safety and effectiveness.
• Local Representation is Required: Non-Saudi manufacturers must appoint a local authorized representative to interact with the SFDA.
• Compliance with International Standards: While SFDA may accept international certifications (like CE or FDA approvals), all devices must meet the specific requirements of Saudi regulations.
• Inspection and Audits: High-risk devices may be subject to GMP inspections and audits by the SFDA to ensure compliance.
• Regular Updates and Renewals: Ensure compliance with SFDA regulations by regularly updating documentation and renewing the registration on time.

Summary of Steps:

1. Preliminary Classification Review: Confirm the device's classification as a D-class (high-risk) device.
2. Appoint Local Representative: If the manufacturer is not based in Saudi Arabia, appoint a local authorized representative.
3. Prepare Documentation: Gather and prepare all required documents, including clinical data, risk management files, ISO certifications, and technical dossiers.
4. Register on Mysfda: Create an account on the SFDA’s e-submission platform and submit the application with all necessary documents.
5. SFDA Evaluation: SFDA conducts a technical review and may request additional information. On-site inspections may be required.
6. Registration Approval: Once the SFDA is satisfied with the submission, approval is granted, and the device is registered.
7. Post-Market Surveillance: After approval, comply with SFDA’s post-market requirements, including adverse event reporting and product recalls.
8. Annual Renewal: Renew the registration every year with updated information and fees.

By following these steps, you can successfully navigate the SFDA registration process for a D-class medical device in Saudi Arabia.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn