For A-class medical device registration with the Saudi Food and Drug Authority (SFDA), you will need to provide several technical documents that demonstrate the safety, effectiveness, and quality of the device. Although A-class devices are typically low-risk, SFDA still requires detailed documentation to ensure compliance with their regulations.

Here is a list of key technical document requirements for A-class medical device registration with Saudi SFDA:

1. Device Description

• Detailed Description: A clear and concise description of the medical device, including its intended use, purpose, and functionality.
• Classification: Confirmation that the device is classified as an A-class (low-risk) device according to the SFDA’s classification system.
• Model and Version Information: Details about different models or versions of the device, if applicable.

2. Risk Management Documentation

• Risk Assessment: A risk management document based on ISO 14971 standards. This should include an assessment of potential risks associated with the device and how these risks are mitigated.
• Risk Control Measures: Provide details on how the risks associated with the device are controlled and minimized. For A-class devices, the risk is typically low, but this still needs to be documented.

3. Labeling and Instructions for Use (IFU)

• Device Labeling: Labels must comply with SFDA requirements, which generally include the following information:
  • Device name
  • Intended use
  • Manufacturer’s name and contact details
  • Batch or serial number
  • Storage conditions
  • Date of manufacture
  • Warnings and precautions
  • CE mark or other regulatory symbols if applicable.
• Instructions for Use (IFU): A document that clearly outlines how the device should be used, including the following:
  • Step-by-step instructions on how to use the device.
  • Safety precautions and potential side effects.
  • Language requirements: The labeling and IFU should be in Arabic or English, or both, depending on SFDA’s requirements.

4. Compliance with International Standards

• ISO 13485 Certification: Evidence that the manufacturer has a Quality Management System (QMS) in place, which is in compliance with ISO 13485. This is necessary for demonstrating that the device is manufactured under controlled conditions.
• ISO 14971 Compliance: Risk management practices based on ISO 14971 standards.
• If applicable, include CE marking documentation or FDA approval to demonstrate compliance with international regulations.

5. Clinical Evidence (if applicable)

• Clinical Data: For low-risk devices (A-class), clinical data may not be necessary, but if the device has been subject to clinical trials or testing, SFDA may request such data to confirm its safety and performance.
  • Clinical testing data might be required for devices that make specific claims or are used in certain sensitive medical applications.

6. Good Manufacturing Practice (GMP) Certificate

• GMP Compliance: Provide documentation or a certificate confirming that the manufacturer complies with Good Manufacturing Practices (GMP). This certification ensures that the device is consistently produced and controlled according to quality standards.
• This could be provided in the form of an ISO 13485 certification or another recognized GMP certification relevant to the device.

7. Certificate of Free Sale (CFS)

• For foreign manufacturers, a Certificate of Free Sale (CFS) from the country of origin is typically required. This document certifies that the device is legally sold and freely available in the manufacturer's home country.
• If the device is already marketed and sold in other countries (e.g., EU, USA), a CFS may also be used to demonstrate that the device complies with their regulatory standards.

8. Safety and Performance Testing Reports

• Depending on the type of device, you may need to provide documentation regarding safety and performance testing. These could include:
  • Biocompatibility tests (e.g., for devices in contact with skin or mucous membranes).
  • Electrical safety tests (for electrical devices).
  • Sterility testing (if the device is sterilized).
  • Mechanical performance testing (for devices requiring structural integrity under use).

9. Manufacturing and Supply Chain Information

• Manufacturing Process: A description of the manufacturing process to demonstrate that the device is produced in a controlled, compliant environment.
• Supply Chain Management: Documentation showing that the manufacturer and all involved suppliers adhere to relevant regulatory standards for safety and quality.

10. Authorization for Local Representation (if applicable)

• If the device manufacturer is located outside of Saudi Arabia, you will need to provide proof of an authorized representative in Saudi Arabia who will submit the registration on behalf of the manufacturer.
• Condition: The local authorized representative must be registered with SFDA and authorized to act on behalf of the foreign manufacturer.

Summary of Technical Document Requirements:

1. Device Description: Detailed information about the device, classification, and intended use.
2. Risk Management Documentation: Based on ISO 14971, including risk assessments and control measures.
3. Labeling and IFU: Properly formatted device labels and instructions for use (in Arabic or English).
4. Compliance with International Standards: ISO 13485 (QMS), ISO 14971 (Risk Management), and other international certifications if applicable.
5. Clinical Evidence: Clinical data if necessary (depending on device type).
6. GMP Certification: Documentation proving GMP compliance.
7. Certificate of Free Sale (CFS): For foreign manufacturers.
8. Safety and Performance Testing: Relevant reports for biocompatibility, electrical safety, mechanical performance, etc.
9. Manufacturing and Supply Chain Information: Description of the manufacturing process and supply chain management.
10. Local Representative Authorization: For foreign manufacturers appointing a local representative in Saudi Arabia.

How to Prepare the Application Documents:

1. Gather the Documents: Ensure that all required documents are collected and up-to-date.
2. Translate if Necessary: Ensure that the labeling, instructions, and any relevant documents are translated into Arabic or English, as required by SFDA.
3. Check for Compliance: Review the SFDA’s regulations for A-class devices to ensure that your documentation fully complies with their requirements.
4. Submit Through the MDES Portal: Once all documents are prepared, submit them through the SFDA MDES portal and pay the application fee.

By carefully preparing the necessary technical documents and following the SFDA guidelines, you can streamline the registration process and avoid potential delays. If you need help with any specific document or requirement, feel free to ask!

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