The time required to obtain SFDA registration for Class B medical devices can vary based on several factors, including the complexity of the device, the completeness of the application, and SFDA’s workload. Typically, the registration process can take several months. Here’s an overview of the stages and timelines involved in the review process:

Stages of the Review Process

1. Pre-Submission Stage:

   • Preparation Time: Time spent gathering and preparing necessary documents and certifications. This varies depending on how quickly you can compile the required information.

2. Submission Stage:

   • Online Application: Submit the application through the SFDA e-Services portal. Ensure all required documents and fees are included. This stage is usually completed once you have submitted the application.

3. Initial Review:

   • Review Duration: SFDA performs an initial review to ensure the application is complete and meets submission requirements. This stage typically takes 1-2 weeks.
   • Request for Additional Information: SFDA may request additional information or documentation if needed, which could extend the review time depending on how quickly you respond.

4. Technical Review:

   • Review Duration: A detailed technical evaluation of the device’s documentation, clinical evidence, and risk management is conducted. This stage usually takes 1-3 months.
   • Complex Devices: More complex devices or those requiring extensive clinical data may take longer for evaluation.

5. Inspection (if required):

   • Inspection Duration: If an inspection of the manufacturing facility or audit of the QMS is required, it may add additional time. Inspections can take several weeks to schedule and complete.

6. Registration Decision:

   • Approval Notification: After the review, SFDA will make a decision on the registration. The time to issue a registration certificate after completing the technical review can range from a few weeks to 1 month, depending on the completeness and accuracy of the submitted information.

Estimated Total Time:

• Typical Duration: On average, the entire process from submission to registration can take between 3 to 6 months. This timeframe can vary based on factors such as the quality of the submission, the need for additional information, and whether an inspection is required.

Factors Affecting Timelines:

• Completeness of Application: Ensuring that the application and supporting documents are complete and accurate can reduce delays.
• Response Time: Promptly responding to SFDA’s requests for additional information or clarification can help expedite the review process.
• Complexity of the Device: More complex devices or those requiring extensive data may require additional time for review.

Contact Us：

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