To apply for A-class medical device registration with the Saudi Food and Drug Authority (SFDA), certain conditions must be met to ensure that the device complies with SFDA’s regulations and standards for safety, quality, and effectiveness. A-class medical devices are classified as low-risk devices, and the registration process is relatively straightforward compared to higher-risk devices, but there are still essential conditions that must be fulfilled.

Here’s a detailed breakdown of the key conditions that need to be met:

1. Classification of the Device

• A-class medical devices are classified as low-risk devices. These are typically non-invasive devices that do not present significant risk to the patient or user.
• Common examples include devices like thermometers, bandages, and low-risk diagnostic equipment.
• Condition: You must confirm that your device fits the A-class classification according to the SFDA Medical Device Classification system. If you are unsure, it is advisable to consult the SFDA’s guidelines or a regulatory expert to verify the classification.

2. Registration of Manufacturer

• The manufacturer of the medical device must be properly registered.
• Condition: The manufacturer must be:
  • Registered with the Saudi SFDA, or
  • If the manufacturer is outside of Saudi Arabia, the device can be registered by a local authorized representative who is registered with the SFDA.

For foreign manufacturers, you must appoint a local authorized representative in Saudi Arabia. This representative will be the official point of contact for SFDA and will submit the application on your behalf.

3. Compliance with International Standards

• The A-class medical device must comply with relevant international quality and safety standards.
• Condition: The following standards may be required to ensure the device meets international safety and quality standards:
  • ISO 13485: Certification for Quality Management Systems (QMS) for medical devices.
  • ISO 14971: Risk management for medical devices.
  • If applicable, CE marking (for European compliance), or other international certifications demonstrating that the device is legally marketed in another jurisdiction.

SFDA may require proof of compliance with these standards.

4. Device Labeling and Instructions for Use (IFU)

• The device must be labeled according to SFDA’s requirements, and the Instructions for Use (IFU) must be clear and provide relevant information to the end user.
• Condition:
  • The labeling should include the device name, intended use, and any warnings or contraindications.
  • The IFU must be written in Arabic or English, or both, depending on SFDA’s preference.
  • If the device is to be used in specific clinical or hospital settings, those conditions should be stated.

5. Safety and Risk Assessment

• For A-class devices, low risk is expected, but SFDA still requires a risk management approach to ensure the device is safe to use.
• Condition:
  • You must provide a risk management report in accordance with ISO 14971 outlining the potential risks and how they are mitigated.
  • Safety data such as biocompatibility reports or electrical safety reports might be required depending on the nature of the device.
  • For devices that do not present significant risks, clinical data may not be necessary, but for more complex devices, clinical or performance data might be requested.

6. Certificate of Free Sale (CFS)

• For foreign manufacturers, a Certificate of Free Sale (CFS) from the country of origin is usually required. This certifies that the device is legally marketed and sold in the manufacturer's home country.
• Condition:
  • If the device is already sold in the manufacturer’s country of origin (or another country), provide a valid CFS issued by the regulatory authority of the country of origin.
  • If the device has a CE mark (European Union), this can be used as proof of compliance with European regulations.

7. Good Manufacturing Practice (GMP) Compliance

• Medical devices must be manufactured according to Good Manufacturing Practices (GMP), ensuring that the devices are consistently produced and controlled to meet quality standards.
• Condition:
  • The manufacturer must be able to demonstrate GMP compliance, either through internal records or third-party certification.
  • If applicable, provide evidence of GMP certification or a relevant audit report confirming compliance with international standards.

8. Performance and Safety Testing

• While A-class devices are low risk, some devices may still require proof of performance and safety testing to confirm they meet safety and efficacy standards.
• Condition:
  • Provide test reports related to the performance, electrical safety, or biocompatibility of the device (if applicable).
  • The type of tests needed will depend on the nature of the device (e.g., electrical testing for electrical devices, biocompatibility testing for devices in contact with the body).

9. Payment of Registration Fees

• The application for A-class medical device registration requires a registration fee to be paid at the time of submission.
• Condition:
  • You must be prepared to pay the registration fees online via the MDES portal.
  • The fee for A-class devices typically ranges between SAR 5,000 to SAR 10,000 (around USD 1,300 to USD 2,600), depending on the type of device.

10. Post-Market Surveillance

• After the device is registered, the manufacturer or authorized representative must comply with post-market surveillance requirements.
• Condition:
  • Be prepared to comply with SFDA’s requirements for post-market surveillance, including reporting any adverse events, recalls, or issues related to the device once it is in the market.
  • You may need to maintain records of adverse event reports or quality complaints related to the device.

11. Local Authorized Representative (for Foreign Manufacturers)

• For foreign manufacturers, the local authorized representative must be appointed to submit the registration and interact with SFDA on your behalf.
• Condition:
  • The representative must be a legal entity based in Saudi Arabia, registered with SFDA.
  • They will handle the registration process and any communications with SFDA regarding the device.

Summary of Conditions:

1. Classification: Ensure the device qualifies as an A-class (low-risk) medical device.
2. Registration of Manufacturer: The manufacturer must be registered, or a local representative must be appointed for foreign manufacturers.
3. Compliance with International Standards: Ensure compliance with ISO 13485, ISO 14971, and other relevant standards.
4. Device Labeling and IFU: Prepare labels and IFU in Arabic or English.
5. Risk Management and Safety: Provide a risk assessment and safety testing data.
6. Certificate of Free Sale: Provide a valid CFS for foreign manufacturers.
7. GMP Compliance: Ensure the manufacturer complies with Good Manufacturing Practices.
8. Testing and Performance Reports: Provide any relevant performance and safety testing reports.
9. Registration Fees: Be prepared to pay the application fees.
10. Post-Market Surveillance: Comply with SFDA’s post-market surveillance obligations.
11. Local Representative: For foreign manufacturers, appoint a local authorized representative.

By meeting these conditions, you can successfully apply for A-class medical device registration with the Saudi SFDA. Would you like more specific information or assistance with any of the conditions?

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