Documents Required for D-Class Medical Device Registration with the Saudi SFDA

When applying for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), you need to submit several key documents that demonstrate the safety, efficacy, and compliance of the device with SFDA standards. Below is a comprehensive list of required documents, along with tips on how to prepare them:

1. Manufacturer Information

• Business Registration Certificate:
  • What it is: A certificate showing the legal status of the manufacturer in their home country (e.g., a certificate of incorporation or business license).
  • How to prepare: Ensure the document is officially signed, stamped, and up-to-date. Provide a certified copy if required by SFDA.
• Manufacturing Facility Information:
  • What it is: Information about the manufacturing site, including Good Manufacturing Practices (GMP) or ISO certification for quality management.
  • How to prepare: Ensure this includes the name, address, and contact information of the manufacturing facility. If applicable, provide ISO 13485 certification or an equivalent standard certification.

2. Local Authorized Representative (LAR) Information

• LAR Registration with SFDA:
  • What it is: Proof that the Local Authorized Representative (LAR) is registered with the SFDA to handle medical device registrations on behalf of a foreign manufacturer.
  • How to prepare: Ensure that the LAR is properly registered on the SFDA's MDES portal. You may need to submit the LAR’s registration certificate with the SFDA.

3. Device Information

• Device Name, Model, and Description:

  • What it is: A detailed description of the device, including its name, model number, intended use, and the type of device (e.g., diagnostic, therapeutic, or non-invasive).
  • How to prepare: Clearly define the intended purpose of the device and its risk level. Provide technical specifications and other relevant product details (e.g., materials used, electrical components, if applicable).

• Device Labeling:

  • What it is: The labels and packaging that will be used in Saudi Arabia, including the product name, intended use, manufacturer details, and usage instructions in both Arabic and English.
  • How to prepare: Ensure that the labels are legible and that the Arabic translation is accurate. This includes ensuring that all warnings, instructions, and safety information are translated.

• User Manual:

  • What it is: A user manual or instruction for use (IFU) that explains how to operate the device safely.
  • How to prepare: Provide a clear, concise manual in Arabic and English. Include all necessary information such as device functions, safety precautions, warnings, and troubleshooting. Ensure that the manual is easy to understand for users and healthcare professionals.

4. Quality Management System (QMS) Information

• ISO 13485 Certificate:
  • What it is: A certificate indicating that the manufacturer complies with international ISO 13485 standards for quality management in the design and manufacturing of medical devices.
  • How to prepare: Obtain a valid and up-to-date copy of the ISO 13485 certificate from the certification body. If your manufacturing process is ISO-certified, this document is typically straightforward to obtain.
  • If applicable: If the device does not require ISO 13485 certification, other comparable certifications or quality audits may be accepted.

5. Device Safety and Performance Information

• Certificate of Free Sale (CFS):

  • What it is: A certificate issued by the regulatory authority of the country of origin, confirming that the device is legally sold in that country and meets local regulatory standards.
  • How to prepare: Obtain a CFS from the appropriate regulatory authority in the device’s home country. Ensure it is signed and stamped by the issuing authority.

• Declaration of Conformity:

  • What it is: A document in which the manufacturer declares that the device conforms to applicable regulations and standards.
  • How to prepare: The Declaration of Conformity should be signed by the manufacturer or a designated representative and indicate compliance with Saudi SFDA regulations as well as any relevant international standards (e.g., ISO 13485, IEC 60601 for electrical safety, etc.).

6. Testing and Certification Reports (if applicable)

• Test Reports (e.g., Safety, Performance, or Biocompatibility Testing):
  • What it is: Test reports to demonstrate that the device meets relevant safety, performance, and biocompatibility standards.
  • How to prepare: If required, obtain reports from accredited laboratories that demonstrate the device meets relevant standards. For example, electrical devices may need to meet IEC 60601 (for electrical safety), and biological devices may need biocompatibility testing reports.

7. Payment of Registration Fees

• Payment Receipt:
  • What it is: Proof of payment for the SFDA registration fee.
  • How to prepare: Ensure that the payment is made electronically through the MDES portal and provide the payment receipt to confirm the transaction.

How to Prepare the Application Files

When submitting your application through the SFDA MDES portal, it’s essential to prepare your documents according to the platform’s requirements. Here are steps on how to prepare the application files:

1. Organize Your Documents:

   • Ensure all required documents are clearly labeled and organized in a logical order. Create separate folders for different categories (e.g., device information, quality certifications, test reports, etc.).

2. Check Document Formats:

   • Most documents should be submitted in PDF or Word format, but always check the SFDA guidelines for specific requirements.
   • Images (such as labeling) should be in high-quality formats (e.g., JPEG or PNG) to ensure legibility.

3. Translation:

   • Ensure that all labels, manuals, and instructions for use are translated into Arabic and English.
   • Use a professional translation service to ensure that the translation is accurate and meets SFDA standards. Mistakes or errors in translation may delay the registration process.

4. File Naming:

   • When preparing the application files, name the files according to their contents (e.g., "Device_Labeling_Arabic_English.pdf", "ISO_Certification.pdf", "CFS_Manufacturer.pdf").
   • Ensure the file names are short, clear, and descriptive to make it easier for the SFDA to process your application.

5. Size and Quality:

   • Ensure that the file sizes are not too large. SFDA systems may have file size limits, so compress files (e.g., images or PDFs) without compromising their quality to fit the limits.

6. Submit via MDES Portal:

   • Once all documents are prepared and organized, log in to the MDES portal and complete the application by uploading each file under the correct section.

Final Checklist Before Submission

• Manufacturer’s business registration certificate.
• LAR registration with SFDA (if applicable).
• Complete device description, including intended use.
• Device labels in both Arabic and English.
• User manual in Arabic and English.
• ISO 13485 certificate or equivalent (if applicable).
• Certificate of Free Sale (CFS).
• Declaration of Conformity.
• Test reports (if applicable).
• Payment receipt for registration fee.

Conclusion

By ensuring that all required documents are complete, accurate, and formatted according to the SFDA’s specifications, you can facilitate a smooth registration process for your D-class medical device in Saudi Arabia. Make sure to pay special attention to the translation of documents and quality of the files before submitting them via the MDES portal.

Let me know if you need further assistance with any specific part of the application process!