To apply for D-class medical device registration with the Saudi Food and Drug Authority (SFDA), certain conditions must be met to ensure that the device is compliant with the regulations in Saudi Arabia. D-class medical devices are generally considered low-risk and non-invasive, but there are still specific requirements to follow. Below are the key conditions that must be met to apply for D-class medical device registration:

1. Classification of the Device

• D-class devices are categorized as low-risk devices that do not involve invasive procedures, and are typically non-critical or non-invasive (e.g., bandages, non-invasive diagnostic devices, etc.).
• Ensure the device is correctly classified: Before applying for registration, verify that your device is correctly classified as D-class according to the SFDA classification criteria. If the device has a higher level of risk or involves invasive procedures, it may fall under a higher classification (A, B, or C) and require additional documentation and testing.

2. Appointment of a Local Authorized Representative (LAR)

• For foreign manufacturers, you are required to appoint a Local Authorized Representative (LAR) who is registered with the SFDA. The LAR will submit the registration application and act as the point of contact for the SFDA in Saudi Arabia.
• For local manufacturers (based in Saudi Arabia), the LAR requirement is not applicable, and the manufacturer can apply directly.

3. Device Compliance with SFDA Guidelines

• Compliance with applicable regulations: The device must comply with SFDA's medical device regulatory guidelines, including quality management systems (e.g., ISO 13485) and labeling requirements.
• Device risk assessment: Even for D-class devices, the manufacturer must perform a risk assessment to ensure the device does not pose any undue risks to health and safety.
• Conformance to safety and performance standards: The device should meet essential safety and performance criteria, either through self-declaration of conformity or certification to international standards.

4. Quality Management System (QMS)

• Manufacturers must have an established Quality Management System (QMS), typically compliant with ISO 13485 or an equivalent standard, ensuring that the device is consistently manufactured to meet regulatory requirements.
• QMS Certification: If the manufacturer is ISO 13485 certified, a copy of this certification should be provided as part of the registration application.

5. Device Documentation Requirements

• The following documents must be prepared and submitted as part of the registration application:
  1. Business Registration Certificate: Proof that the manufacturer is legally registered and authorized to manufacture the device.
  2. Certificate of Free Sale (CFS): The device must be sold legally in the manufacturer's home country. This certificate is typically issued by the national health authority of the manufacturer’s country.
  3. Declaration of Conformity: A statement from the manufacturer confirming that the device conforms to the relevant international and local regulatory standards (e.g., ISO standards, SFDA guidelines).
  4. Device Labeling and User Manual: Labels and user manuals must be provided in Arabic and English, meeting SFDA's labeling standards for medical devices.
  5. Test Reports: If applicable, any safety and performance test reports required by the SFDA (e.g., electrical safety, biological safety) must be submitted.
  6. ISO 13485 Certification: If applicable, a copy of the ISO 13485 certificate or equivalent QMS certification should be submitted to demonstrate compliance with international quality standards.

6. Compliance with SFDA's Arabic Labeling Requirements

• Labels, packaging, and user manuals must be provided in Arabic and English, following SFDA's requirements.
• Ensure that the Arabic translation is accurate and reflects the information provided in the English version. All necessary information such as product name, intended use, warnings, and safety instructions must be translated into Arabic.

7. Medical Device Risk Assessment

• The manufacturer must conduct a risk assessment to evaluate the potential risks associated with the device's use. Even for D-class devices, this ensures that the device does not present any undue risks to users or patients.
• The risk management process should follow international standards like ISO 14971 for risk management, which is commonly used in medical devices.

8. Device Market Status

• The device must be commercially available in the manufacturer’s home country or other markets. This is often confirmed by the Certificate of Free Sale (CFS), which certifies that the device is sold in the manufacturer's country of origin under the relevant regulatory framework.
• Market Authorization: If the device is already authorized in another country (e.g., the EU, USA, Canada), it may help streamline the SFDA registration process.

9. SFDA Registration Portal Account

• You (or the appointed LAR) must have a registered account on the SFDA's Medical Device Electronic Services (MDES) portal.
• Registration via the MDES portal is required for all submissions, including uploading application forms, required documents, and paying fees.
• The application process is electronic, so having access to the platform and understanding how to navigate it is crucial for a successful registration.

10. Compliance with Post-Market Surveillance Requirements

• Once the device is registered, the manufacturer and LAR are responsible for ensuring the device’s safety and performance post-market. This includes reporting any adverse events or device issues that arise after the device is marketed in Saudi Arabia.
• The manufacturer must have systems in place to monitor the device's performance and recall it if needed.

Additional Conditions

• Proprietary/Patent Information: If the device is patented or proprietary, you may need to provide documentation proving the manufacturer’s ownership or licensing rights over the device’s design or technology.

• Technical Documentation: Depending on the nature of the device, SFDA may request additional technical documentation, such as detailed design and manufacturing process information, material specifications, or biocompatibility studies for medical devices that interact with the human body.