A-Class Medical Device Registration with Saudi SFDA

In Saudi Arabia, medical devices are regulated by the Saudi Food and Drug Authority (SFDA). The devices are classified into different categories based on their level of risk. A-class medical devices are considered low-risk devices. These devices generally have minimal or no potential to cause harm to patients when used as intended.

A-class devices include simple, non-invasive items such as bandages, thermometers, surgical instruments that do not penetrate the body, and some low-risk diagnostic tools. They are typically considered safe and are subject to less stringent regulatory controls compared to higher-class devices.

Steps to Apply for A-Class Medical Device Registration with SFDA

1. Device Classification

Before applying, you must confirm that your product qualifies as an A-class medical device. The SFDA classifies devices into four classes:

• Class A: Low-risk (e.g., bandages, non-invasive diagnostic devices).
• Class B: Medium-risk.
• Class C: High-risk.
• Class D: Very high-risk.

You can verify the classification based on your device’s intended use and its risk profile as outlined by SFDA's classification guidelines.

2. Ensure Compliance with SFDA Requirements

A-class devices must meet the following criteria:

• Conformance to Standards: The device must comply with recognized international standards such as ISO 13485 for quality management systems, and other relevant ISO standards.
• Safety and Efficacy Documentation: You must provide evidence that the device is safe for its intended use, and this is usually demonstrated through testing and quality control processes.
• Labeling: Clear and comprehensive labeling is required. The instructions for use, contraindications, and warnings should be in Arabic or English.

3. Prepare Necessary Documentation

SFDA requires a set of documents when submitting an application. These include:

• Device Description: A detailed description of the device, its intended use, and its features.
• Risk Assessment: An analysis of any risks associated with the device and how those risks are mitigated.
• Manufacturing Information: This should include details about the device's manufacturing process, quality management system (such as ISO 13485), and compliance with Good Manufacturing Practices (GMP).
• Certifications: You must submit a Certificate of Free Sale (CFS) if the device is sold in the country of origin. It shows that the device is legally available in the market.
• Authorized Representative: If you are not based in Saudi Arabia, you will need to appoint a local authorized representative who will manage the registration process and liaise with SFDA on your behalf.

4. Submit the Registration Application

• Online Submission: You must submit your application through the SFDA’s Medical Devices Electronic Registration System (MDES). The system is an online platform that handles all aspects of the registration process.
• Authorized Representative Requirement: If you are a foreign manufacturer, you will need to provide the details of your local authorized representative in Saudi Arabia, who must be registered with SFDA.

5. SFDA Evaluation

Once the application is submitted, SFDA will evaluate the device’s documentation. They will assess whether the device complies with the regulatory standards and whether the risk of the device is accurately classified.

• SFDA may request additional information or clarification during the evaluation process.
• For A-class devices, this process is generally faster than for higher-risk classes, as the regulatory burden is lighter.

6. Approval and Registration

If SFDA is satisfied with the application and the device meets all the necessary requirements, they will issue a registration certificate. This certificate allows you to legally market the medical device in Saudi Arabia.

7. Post-Market Surveillance

After registration, manufacturers are required to conduct post-market surveillance to monitor the safety and performance of the device in the market. Any adverse events or issues with the device must be reported to SFDA.

Key Considerations for A-Class Medical Device Registration

• Authorized Representative: If you're a foreign manufacturer, appointing a local authorized representative in Saudi Arabia is mandatory for A-class devices.
• Language Requirement: All documents submitted to SFDA must be in Arabic or English. This includes product labeling and instructions for use.
• Compliance with Standards: SFDA requires compliance with international standards. Make sure your device meets ISO 13485 and other relevant standards.
• Fees: There are fees for registration, and the amount depends on the type and classification of the device.

Helpful Resources

• SFDA Website: www.sfda.gov.sa
• MDES Portal: The portal for electronic submission and registration.

Would you like more details on any of the steps or specific requirements?

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