The costs and time involved in obtaining SFDA registration for a Class A medical device in Saudi Arabia can vary depending on several factors. Here’s a general overview:

Costs

1. Application Fees:

   • The cost for registering a Class A medical device with the SFDA is typically lower than for higher-risk classes. The exact fee can vary, so it's best to consult the SFDA’s fee schedule or contact their support for the most current rates.

2. Additional Costs:

   • Local Representation: If your company is based outside Saudi Arabia, you may need to pay for local representation or distribution services.
   • Documentation Preparation: Costs may include expenses for preparing and translating documents, technical reports, and compliance certificates.
   • Quality Management System: While not mandatory for Class A devices, if you choose to implement or update a quality management system, this could incur additional costs.

Time Involved

1. Preparation Time:

   • Preparing the necessary documentation and ensuring that all requirements are met can take several weeks to a few months, depending on the complexity of the device and the readiness of your documentation.

2. Submission and Review:

   • Once submitted through the SFDA Unified Electronic Platform (UAE), the review process for Class A devices is generally faster compared to higher-risk devices. The SFDA typically processes Class A device registrations within a few weeks to a couple of months.

3. Approval and Certification:

   • After review, if there are no issues or additional requests for information, you can expect to receive the registration certificate within a few weeks from the end of the review period.

Overall Timeline

Typical Duration:

• Preparation: 4 to 8 weeks (depends on the complexity and availability of documentation).
• SFDA Review and Approval: 4 to 8 weeks.

Total Time Estimate:

• Overall, the process from preparation to receiving the registration certificate can take approximately 2 to 4 months.