The process to obtain Class C medical device registration with the Saudi Food and Drug Authority (SFDA) typically takes between 3 to 6 months. However, the exact duration can vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether the SFDA requires additional documentation or inspections.

Here’s a breakdown of the key stages involved in the registration process and an estimated time frame for each:

1. Preparation and Submission of Application (2–4 weeks)

• Document Collection and Preparation: This stage involves gathering and preparing the required documents, including the technical file, clinical data, risk management reports, GMP certifications, and quality management system documentation.
• If the manufacturer is located outside of Saudi Arabia, it also includes appointing a local authorized representative.
• The time taken to prepare and submit a complete application depends on how quickly these documents can be gathered and verified. The more complex the device, the more time this stage may take.

2. SFDA Review and Evaluation (6–8 weeks)

• Once the application is submitted, the SFDA will begin reviewing the technical documentation, including the safety and performance data, clinical trial reports (if applicable), and risk management strategies.
• If the device requires clinical data or additional safety and performance evidence, this review can take longer.
• The SFDA may request clarifications or additional documents, which can add time to the overall process.

3. Manufacturing Site Inspection (if required) (2–4 weeks)

• If the device is manufactured outside Saudi Arabia, the SFDA may conduct an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP). This inspection may add several weeks to months to the overall processing time, depending on the location of the manufacturing site and the availability of the inspection team.

4. Decision and Issuance of Registration Certificate (2–4 weeks)

• After reviewing the documentation and possibly conducting an inspection, the SFDA will make a decision on the application. If the device is approved, the SFDA will issue a registration certificate, which is typically valid for five years.
• If additional information is required, the process may be delayed.

Factors That Can Affect the Duration:

• Completeness of Application: Submitting a complete and accurate application can significantly reduce the processing time. If the SFDA needs to request additional documentation or clarification, this will add time to the process.
• Device Complexity: Class C devices are considered moderate-to-high risk, and therefore, the SFDA may require a thorough review. Devices with complex technology or clinical data requirements may take longer to review.
• Manufacturing Site Location: If the manufacturing site is outside of Saudi Arabia, the inspection process can add time. If the SFDA is located far from the site, scheduling and conducting the inspection may take additional weeks.
• Regulatory Queries: If the SFDA requests further information, such as clarification on the risk management process, the timeline may extend based on how quickly the manufacturer responds.

Summary:

• Typical duration for Class C medical device registration with the Saudi SFDA is around 3 to 6 months.
• Application preparation and document collection can take 2–4 weeks.
• SFDA review and evaluation typically takes 6–8 weeks, but could be longer for complex devices.
• If an inspection of the manufacturing site is needed, it could add 2–4 weeks or more.
• The entire process may take longer if additional documents or clarifications are requested by the SFDA.

Manufacturers should plan accordingly, ensuring that all required documents are submitted on time and respond promptly to any queries from the SFDA to help streamline the registration process.

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