The time required to apply for Class C medical device registration with Singapore's Health Sciences Authority (HSA) can vary depending on the complexity of the device, the completeness of the submission, and the quality of the documentation. However, the typical timeline for the registration process is approximately 3 to 6 months.

Here’s a breakdown of the stages in the review process and their estimated timelines:

1. Application Submission (Initial Stage)

• Timeline: 1–2 weeks
• Activities:
  • Account Setup: If you don’t already have one, create an account on the Health Products Portal (HPP), where you’ll submit the application.
  • Document Preparation: Ensure that all required documents are ready for submission, such as the clinical evaluation report, risk management plan, labeling, and other technical documentation.
  • Application Submission: Complete and submit the Class C medical device registration application with all required documentation via the Health Products Portal (HPP).

2. Initial Screening and Validation (First Review by HSA)

• Timeline: 1–2 weeks
• Activities:
  • Completeness Check: HSA will perform an initial check to ensure that all required documents have been submitted and that the application is complete.
  • Preliminary Evaluation: If the application is incomplete or if documentation is missing, HSA will inform the applicant and request the necessary documents.
  • Application Fee Payment: The registration fee is due at this stage if not paid earlier.
  If the application passes this screening, HSA proceeds to the next review stage.

3. Detailed Technical Review and Risk Classification Verification

• Timeline: 4–6 weeks (or longer for complex cases)
• Activities:
  • Technical Evaluation: HSA’s technical team will thoroughly review the application’s submitted documents, including the clinical evaluation, risk management report, and any performance and safety testing data.
  • Risk Classification: For Class C devices, HSA will verify whether the device is correctly classified based on its intended use, risk level, and the supporting evidence. This includes ensuring that the device complies with applicable international standards (e.g., ISO 13485, ISO 14971, ISO 10993).
  • Review of Labeling: HSA will also assess the device’s labeling and instructions for use to ensure they comply with Singapore's labeling requirements.

4. Additional Information or Clarification (if required)

• Timeline: 1–4 weeks (if applicable)
• Activities:
  • If HSA requires additional information or clarification (e.g., new clinical data, performance test results, or manufacturing details), they will send a request to the applicant.
  • Applicants must respond promptly and submit the requested documents. This stage can take additional time depending on the complexity and the applicant’s ability to provide the required information.

5. Final Review and Approval Decision

• Timeline: 1–2 weeks
• Activities:
  • Final Evaluation: After reviewing all the required documents and any additional information, HSA will make a final assessment.
  • Approval or Rejection: If the device meets all requirements, HSA will approve the application and issue a registration certificate for the Class C medical device. If there are concerns or deficiencies, HSA may reject the application or request further revisions.
  • Issuance of Certificate: Upon approval, HSA will issue the registration certificate for the device. This allows the manufacturer to market the device in Singapore.

6. Post-Approval Reporting and Monitoring

• Ongoing: After approval, the manufacturer must continue to comply with post-market surveillance, reporting of adverse events, and periodic updates to ensure continued regulatory compliance.

Estimated Total Timeline:

• The total time for Class C medical device registration with HSA can generally take around 3 to 6 months, depending on factors such as:
  • Completeness of the application
  • Complexity of the device
  • Promptness in responding to HSA’s requests for additional information or clarification
  • The device’s compliance with applicable regulations

Key Factors that Affect Timeline:

• Quality of the Submission: Well-prepared applications with complete and accurate documentation may be processed more quickly.
• Complexity of the Device: Devices that are high-risk or have complex technical specifications may require more detailed review, extending the timeline.
• Requests for Additional Information: Any requests from HSA for additional data or clarification can add time to the process, especially if the applicant takes time to gather and submit the information.

By ensuring that all documentation is thorough, complete, and in line with HSA’s guidelines, you can help speed up the process and avoid delays during the review.

Let me know if you need more information on any specific stage of the process!

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