The cost and time for obtaining SFDA registration for Class B medical devices in Saudi Arabia can vary. Here’s a general overview:

1. Cost:

   • Application Fee: The registration fee typically ranges from SAR 5,000 to SAR 10,000. However, exact fees can vary based on the device type and any additional services required.
   • Additional Costs: Be aware of potential extra costs for document translation, facility inspections, and consultant fees if applicable.

2. Timeline:

   • Preparation: Gathering and preparing all necessary documentation may take several weeks to months, depending on the complexity of the device.
   • Application Review: Once submitted, the SFDA’s review process generally takes around 2 to 6 months. This timeline can be affected by the completeness of the submission and any additional information requests or inspections.
   • Inspection: If an inspection of the manufacturing facility is required, this could add additional time to the overall process.

Overall, you should anticipate around 6 to 12 months from the start of the preparation phase to receiving the registration certificate. If you need precise details or current rates, checking directly with SFDA or a regulatory consultant would be advisable.

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