Costs and Time Involved in Applying for D-Class Medical Device Registration with the Saudi SFDA

The registration process for D-class medical devices with the Saudi Food and Drug Authority (SFDA) is generally faster and less costly compared to higher-risk medical devices. However, the exact costs and timeline can vary depending on several factors such as the complexity of the device, the required documentation, and the services provided by the local authorized representative (LAR).

Here's a breakdown of the typical costs and time involved:

1. Registration Costs

A. SFDA Registration Fees

The SFDA registration fees for D-class medical devices are typically lower compared to higher-risk devices. However, the exact cost can vary depending on the device and the nature of the registration process. Here are the general cost components:

• Initial Registration Fees: The cost for registering a D-class medical device can range from SAR 2,000 to SAR 5,000 ($530 to $1,300 USD) for a single product.

  • This fee includes the basic application and review process by the SFDA.
  • The fee is typically non-refundable, regardless of whether the application is approved or rejected.

• Local Authorized Representative (LAR) Fees: If you are a foreign manufacturer, you will need to appoint a local representative in Saudi Arabia, and this will incur additional costs.

  • The cost for engaging an LAR can vary based on the services they provide but typically ranges from SAR 5,000 to SAR 15,000 ($1,300 to $4,000 USD) per year. This fee is for services including submitting the registration, dealing with SFDA communication, and ensuring compliance with Saudi regulations.
  • The LAR may also charge for additional services such as post-market surveillance, renewal of registration, and managing any required updates.

• Additional Costs:

  • Translation Fees: Documents (such as labeling, instructions for use, etc.) must be provided in both Arabic and English. If your documentation is not already in these languages, you may incur translation costs. These fees can vary but generally range from SAR 1,000 to SAR 3,000 ($260 to $800 USD) for comprehensive translations.
  • Testing and Certification Fees: If your device requires additional testing or certification (such as safety, performance, or biocompatibility tests), these can add extra costs. Testing fees will depend on the type of tests required and the testing laboratories you use, but they generally range from SAR 3,000 to SAR 10,000 ($800 to $2,700 USD).

2. Time Involved in the Registration Process

The time required to complete the D-class medical device registration process with the SFDA is relatively quick compared to higher-risk devices, given that these devices are low-risk and generally require less documentation. The entire process typically involves the following stages:

A. Pre-Submission Phase

• Device Classification and Documentation Preparation: This involves determining whether your device falls under the D-class category, preparing the necessary documentation, and engaging with an LAR if you are a foreign manufacturer.
• Time: This phase can take anywhere from 2 to 4 weeks, depending on how quickly you can gather the required documentation and select a local representative.

B. Submission and Review Process

• Once the application is submitted to the SFDA’s Medical Device Electronic Services (MDES) portal, the review process for D-class medical devices is typically shorter and simpler than for higher-risk devices.
• Time: The review by the SFDA usually takes 2 to 6 weeks, assuming that all documents are in order. If additional documentation or clarifications are required, this may extend the timeline.

C. Approval and Registration

• If the SFDA is satisfied with the documentation and no additional information is needed, they will issue the registration certificate.
• Time: Once approved, the registration certificate is typically issued within 1 to 2 weeks.

Estimated Total Time for Registration

• Total Estimated Time: The entire process from the initial preparation to receiving the SFDA registration certificate typically takes 6 to 8 weeks, assuming all documentation is complete and there are no significant issues with the application.
• Factors Affecting Time: Delays can occur if:
  • Additional information or corrections are required by the SFDA.
  • There are issues with documentation (e.g., incomplete or incorrectly filled forms).
  • If translations or testing are required, these additional steps may add more time to the process.

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