To successfully register a B-class medical device with the Saudi Food and Drug Authority (SFDA), you need to submit a comprehensive application with various required materials. Below, I’ve outlined the key documents and materials required for registration, as well as guidance on how to prepare the application documents to meet SFDA’s requirements.

Required Materials for B-Class Medical Device Registration with SFDA

1. Device Description and Classification

   • Description of the Device: Provide detailed information about your device, including:
     • Name, model, and product code.
     • Intended use (i.e., what the device is used for).
     • Target patient population and clinical indications (if applicable).
     • Device components and their functionality.
   • Device Classification: Confirm that the device is classified as B-class according to SFDA’s classification system, which is based on the device’s risk level and intended use. Provide justification or evidence for the classification.

2. Risk Management Documentation

   • Risk Analysis Report: This document should include a risk assessment for the device, based on the ISO 14971 standard (Risk Management for Medical Devices). This should cover:
     • Potential hazards associated with the device.
     • Risk mitigation measures implemented.
     • Any testing or validation to ensure safety.
   • If your device falls under a higher risk classification, provide more detailed information.

3. Conformity Assessment and Quality Management System (QMS)

   • ISO 13485 Certification (or equivalent): Provide proof of compliance with a recognized Quality Management System (QMS), such as ISO 13485. This certification demonstrates that your manufacturing processes are compliant with international standards for medical devices.
     • If applicable, provide copies of QMS audits or certificates issued by accredited bodies.
   • Conformity Declaration: If your device is CE-marked, FDA-approved, or certified by other competent authorities, include relevant conformity assessment documentation to demonstrate that the device meets international regulatory standards.

4. Clinical Data or Clinical Evaluation Report (if applicable)

   • For new or high-risk devices, you may need to provide clinical data or a clinical evaluation report that demonstrates the device’s safety and performance.
     • The clinical data should support the claims made by the device and show that it has been tested in accordance with appropriate standards.
     • If the device is substantially similar to a device already approved in Saudi Arabia or another region, you can reference existing clinical data (e.g., from CE-marking or FDA approval).

5. Labeling and Instructions for Use (IFU)

   • Device Labeling: Provide the labeling information in Arabic and English. This should include:
     • Product name, model, and manufacturer details.
     • Intended use, indications for use, contraindications, and warnings.
     • Instructions for safe use and precautions.
     • Manufacturer’s name and address, and authorized representative’s details (if applicable).
     • Lot or serial number and expiration date (if applicable).
   • Instructions for Use (IFU): Submit the IFU that provides step-by-step instructions on how to use the device, including precautions and troubleshooting. Ensure it is clear and easy to understand.
     • The IFU should be written in Arabic and English (or both languages depending on SFDA's requirements).

6. Manufacturing Site Information

   • Manufacturing Facility Information: Provide details of the manufacturing site where the device is produced, including:
     • Name and address of the manufacturing facility.
     • Compliance with Good Manufacturing Practices (GMP).
     • If applicable, submit the GMP certificate issued by a recognized authority.
   • Certificate of Free Sale (DFS): If the device is legally sold in the country of origin (e.g., CE-marked, FDA-approved), provide a Certificate of Free Sale that indicates the device is allowed to be marketed and sold in that country.

7. Testing and Safety Data

   • Preclinical Testing: Provide any preclinical testing data that supports the device’s safety and efficacy (e.g., bench testing, electrical safety testing, biocompatibility testing).
     • This data is required for devices that come in contact with patients or perform critical functions.
   • Performance Data: If the device performs specific functions, include performance testing results to demonstrate that the device works as intended under normal use conditions.

8. Additional Documents (if applicable)

   • Toxicology Report: For devices that involve materials that may impact human health (e.g., chemicals, coatings), provide a toxicology report.
   • Environmental Impact Assessment: If applicable, provide a report evaluating the environmental impact of the device.
   • Sterility Assurance (if applicable): If your device is sterile, provide sterility assurance documentation, such as sterilization validation reports.

How to Prepare the Application Documents for SFDA Registration

1. Organize Documents According to SFDA Guidelines

   • SFDA has specific guidelines for document submission, which are available on the MDES portal and should be followed strictly.
   • Group your documents into sections based on the application requirements, such as:
     • Device Description
     • Risk Management
     • Clinical Data
     • Conformity Assessment
     • Labeling
     • Testing and Safety Data

2. Ensure Correct Format and Language

   • All documents submitted to SFDA must be in Arabic or English (or both if specified).
   • Ensure that your IFU, labeling, and other important documents are available in both languages to facilitate the review process.

3. Verification of Accuracy and Completeness

   • Double-check all documents to ensure that they are accurate and complete.
   • Ensure that all required sections are addressed and that no relevant information is omitted.
   • Pay special attention to device classification, risk management documentation, and performance data as SFDA will scrutinize these areas closely.

4. Translations and Certification

   • If any documents are in a language other than Arabic or English, they must be translated by an accredited translation service and certified for authenticity.
   • SFDA will not accept untranslated or uncertified documents.

5. Online Submission Through MDES Portal

   • Once all documents are prepared, log in to the MDES portal and begin the online submission process.
   • Upload the documents in the required format (usually PDF or Word format).
   • Fill out the registration form with accurate information and complete the required fields.

6. Pay Registration Fees

   • Pay the required registration fees via the MDES portal. Keep a record of the payment receipt for your records.
   • Ensure that the payment corresponds to the correct classification and submission type.

7. Follow Up

   • After submission, monitor the status of your application through the MDES portal. SFDA may request additional information or clarification, so be prepared to respond promptly.
   • Ensure that your local authorized representative (if applicable) stays in contact with SFDA to facilitate the review process.

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