The time it takes to obtain A-class medical device registration with the Saudi Food and Drug Authority (SFDA) generally ranges from 4 to 12 weeks. However, the exact duration depends on various factors, including the completeness of your application and the SFDA's review process.

Breakdown of the Process:

1. Document Preparation (Timeframe: 1-2 weeks)

   • Preparing the necessary documentation for submission, such as device descriptions, safety data, certificates, and labeling, can take some time depending on how quickly you can gather and organize all the required materials.

2. Submission and Acknowledgment (Timeframe: a few days)

   • Once the application is submitted through the SFDA’s e-portal (MDRS), you will receive an acknowledgment from the SFDA confirming the receipt of your application. This typically takes a few days.

3. SFDA Review (Timeframe: 4-8 weeks)

   • After submission, the SFDA will review the documents. For A-class devices, which are considered low risk, the review process is typically faster than higher-risk devices. The SFDA will check for compliance with regulations, safety standards, and proper labeling. This process usually takes 4 to 8 weeks, although it may vary depending on the SFDA's workload.

4. Approval and Registration Certificate (Timeframe: 1-2 weeks)

   • If the application is approved, the SFDA will issue the Medical Device Registration Certificate, allowing the product to be marketed in Saudi Arabia. This final step typically takes 1 to 2 weeks.

Total Estimated Timeframe:

• Total processing time: 4 to 12 weeks (depending on factors such as document completeness, SFDA review time, and any requests for additional information).

Factors That Can Affect Processing Time:

1. Completeness and Accuracy of Documentation:

   • If your application is complete and all documents are accurate and compliant with SFDA guidelines, the review process will proceed smoothly.
   • If any documentation is missing or unclear, the SFDA may ask for additional information, which can delay the process.

2. SFDA Workload:

   • If the SFDA is processing a high volume of applications at the time, this may extend the review time. However, A-class devices typically have a faster review process due to their lower risk classification.

3. Response Time to Queries:

   • If the SFDA requests additional information or clarifications, quick and efficient responses from your side can help prevent delays in processing.

In Summary:

On average, it takes 4 to 12 weeks to obtain A-class medical device registration with Saudi SFDA. This timeline can be shorter or longer depending on the specifics of your application and how quickly you can respond to any additional requests or clarifications from the SFDA.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn