When registering a B-class medical device with the Saudi Food and Drug Authority (SFDA), you must provide a set of technical documents that demonstrate the safety, efficacy, and quality of the device. These documents will help SFDA evaluate your device and ensure that it meets Saudi regulatory requirements. Below is a comprehensive list of the technical document requirements for registering a B-class medical device with SFDA:

Technical Document Requirements for B-Class Medical Device Registration

1. Device Description and Classification

• Description of the Device: Provide a detailed description of the device, including:
  • The intended use and clinical indications.
  • The design, functionality, and operation of the device.
  • Its mode of action (how the device works).
• Device Classification: Demonstrate that the device is classified as B-class according to the SFDA's medical device classification criteria.
  • The classification should be based on factors such as intended use, risk level, and invasiveness.

2. Risk Management Documentation

• Risk Analysis and Management Report: You must provide a risk management document that demonstrates how risks associated with the device have been identified, assessed, and mitigated.
  • The report should be in accordance with ISO 14971, which is the standard for the application of risk management to medical devices.
  • The risk analysis should identify potential hazards (e.g., electrical, biological, mechanical) and provide the risk control measures implemented.

3. Quality Management System (QMS) Certification

• ISO 13485: Provide proof of a Quality Management System (QMS) for manufacturing the medical device.
  • The manufacturer must comply with ISO 13485, which is the international standard for QMS in the medical device industry.
  • If the device is already approved in another regulatory jurisdiction (e.g., EU, USA), providing ISO 13485 certification may suffice as proof of quality compliance.

4. Clinical Evaluation

• Clinical Data (if applicable): For some B-class devices, you may need to submit clinical data or a clinical evaluation report.
  • This data should support the safety and efficacy of the device for its intended use.
  • If the device has been approved in other regulatory jurisdictions (e.g., FDA, CE Mark), you may be able to reference existing clinical data or studies.

5. Labeling and Instructions for Use (IFU)

• Labeling: Submit a copy of the device labeling in both Arabic and English. The labeling should include the following information:
  • Device name and model number.
  • Manufacturer information (name, address, contact details).
  • Intended use, clinical indications, and any contraindications.
  • Warnings, precautions, and safety instructions.
  • Storage conditions and shelf life (if applicable).
• Instructions for Use (IFU): Provide the IFU for the device in both Arabic and English. The IFU must contain:
  • Clear instructions for operating the device.
  • Warnings, contraindications, and limitations.
  • Information on maintenance, cleaning, and sterilization (if applicable).

6. Conformity Assessment and Regulatory Approvals

• Conformity Declaration: Submit a Conformity Declaration indicating that the device meets the applicable regulatory requirements for safety, efficacy, and quality.
• Regulatory Approvals: If the device has been approved in other markets (e.g., FDA, CE Mark, Health Canada), you can submit proof of these approvals to support your application. This may help expedite the process.

7. Safety and Performance Data

• Preclinical Testing Data: Submit any available preclinical testing data that demonstrates the safety and performance of the device.
  • This may include data from mechanical, electrical, or biological testing.
• Biocompatibility Testing (if applicable): For devices that come into contact with the human body (e.g., implants, contact lenses), provide biocompatibility testing data in compliance with ISO 10993.

8. Sterility and Manufacturing Information (if applicable)

• Sterility Assurance: If the device is sterile or sterile packaging is involved, provide documentation on sterility assurance, including the sterilization method used (e.g., autoclaving, gamma radiation).
• Manufacturing Site Compliance: Provide details of the manufacturing site and its compliance with Good Manufacturing Practices (GMP).
  • If the device is manufactured outside Saudi Arabia, provide GMP certification from a recognized authority.
  • SFDA may also request an inspection of the manufacturing facility.

9. Certificate of Free Sale (DFS)

• If applicable, submit a Certificate of Free Sale (DFS) from the country of origin or from a recognized regulatory authority.
  • The DFS certifies that the device is legally marketed and sold in the country of origin.

10. Post-Market Surveillance Plan

• Post-Market Surveillance (PMS): Provide a plan for post-market surveillance, which outlines how the device will be monitored for safety and performance once it is in the market.
  • The plan should include how adverse events and complaints will be handled, how recalls (if necessary) will be conducted, and how changes to the device will be managed.