The Class C medical device registration process with the Health Sciences Authority (HSA) in Singapore typically takes 3 to 6 months from submission to approval. The timeline can vary depending on several factors, such as the complexity of the device, the completeness of the application, and the need for additional information or clarification during the review process.

Review Process Stages and Timelines:

1. Initial Screening (1-2 weeks):

   • Once the application is submitted, HSA will perform an initial review to verify that all required documents are provided and the application is complete. If there are any issues (e.g., missing documents or information), HSA will notify you, which can delay the process.

2. Detailed Technical Evaluation (4-6 weeks or more):

   • After the initial screening, HSA will begin the detailed technical evaluation. This is where HSA assesses the device’s safety, performance, clinical data, risk management, and labeling.
   • If the application is straightforward and there are no additional questions or requests for information, this phase typically takes about 4-6 weeks.
   • If there are complex issues, such as the need for additional clinical evidence or clarification, this phase may take longer.

3. Approval and Issuance of Registration Certificate:

   • Once HSA is satisfied with the application, and all regulatory requirements are met, HSA will issue the registration certificate. This can take a few additional weeks after the technical evaluation is completed.

Factors that May Affect the Timeline:

• Completeness of Application: The more complete and accurate the documentation submitted, the quicker the processing time.
• Complexity of the Device: Devices that require more detailed clinical data, additional safety testing, or a more complex risk management strategy may take longer to review.
• Requests for Additional Information: If HSA requires further information or clarification during the review process, this may extend the timeline.

Renewal and Post-Market Monitoring:

• Class C device registration is valid for 5 years. After this period, you will need to submit a renewal application. Be mindful of post-market monitoring requirements, including reporting adverse events, device recalls, or significant changes in the device.

In Summary:

• The typical registration timeline for Class C medical devices with HSA is around 3 to 6 months, but this can vary depending on the specifics of the application and any additional requests from HSA.

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