Cost and Timeframe for A-Class Medical Device Registration with Saudi SFDA

1. Cost of Registration

The cost for registering an A-class medical device with the Saudi Food and Drug Authority (SFDA) is generally lower compared to higher-risk device classifications (Class B, C, and D). However, the specific fees can vary depending on factors such as the type of device, the complexity of the registration process, and whether the manufacturer is a foreign entity.

• Registration Fees: The fees for A-class devices can typically range from SAR 5,000 to SAR 10,000 (approximately USD 1,300 to USD 2,600). These fees cover the cost of reviewing and processing the registration application.

• Additional Fees:

  • Late fees: If re-registration or a modification is required, there may be additional fees.
  • Authorized Representative Fees: If you're a foreign manufacturer, you will need a local authorized representative in Saudi Arabia. Their fees vary based on the services they provide and are typically a separate cost.

You will be required to pay the registration fee during the application submission process via the MDES portal (Saudi SFDA's online registration platform).

Note: The SFDA's fees are subject to change, so it’s advisable to confirm the exact amount by visiting the SFDA website or through your local authorized representative.

2. Timeframe for Registration

The timeframe for A-class medical device registration with the Saudi SFDA is generally faster than for higher-class devices due to their lower-risk nature and simpler regulatory requirements. However, the time taken can vary depending on several factors such as:

• Completeness of your Application: If all required documentation is provided correctly, the process will be faster. Incomplete or incorrect applications may lead to delays.
• SFDA Workload: The registration process may take longer if SFDA is experiencing a high volume of applications.

Typical Timeframe:

• Average Time: The registration of an A-class device typically takes between 4 to 6 weeks from the date of submission, assuming the application is complete and there are no issues with the documentation.
• Complex Cases: If additional information or clarification is required by SFDA, the process can take longer, potentially extending the timeline to 8 weeks or more.

Factors That Could Impact the Timeframe:

• Additional Documentation Requests: SFDA may request supplementary information or clarification on certain aspects of the device. This can add time to the process.
• Involvement of Authorized Representative: If you are using a foreign manufacturer, the local authorized representative in Saudi Arabia plays a key role in ensuring the registration goes smoothly. Their responsiveness and efficiency can also impact the overall timeline.
• Device-Specific Requirements: Certain devices might require additional testing, clinical data, or compliance checks, which could extend the registration time.

Summary of Cost and Timeframe for A-Class Registration:

• Registration Fees: SAR 5,000 - SAR 10,000 (approx. USD 1,300 - USD 2,600).
• Timeframe: Typically 4 to 6 weeks (can extend up to 8 weeks if additional information is needed).

Would you like to know more about any specific aspect of the registration process or how to prepare your documents for SFDA submission?

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