The typical time to obtain Class C medical device registration with the Health Sciences Authority (HSA) in Singapore is approximately 3 to 6 months. However, the exact duration may vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether additional information or clarifications are required during the review process.

Breakdown of the Timeframe:

1. Initial Screening (1-2 weeks):

   • After submission, HSA will conduct an initial review to verify that all required documents and information are provided. If there are any missing or incomplete items, HSA will notify you, which can delay the process.

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

   • This phase involves HSA's detailed assessment of the device's safety, effectiveness, clinical data, and risk management. Typically, this takes about 4-6 weeks, but can be longer if additional clinical data or clarifications are requested.

3. Issuance of Registration Certificate (2-4 weeks):

   • After the technical evaluation is complete and the device meets all regulatory requirements, HSA will issue the registration certificate. This can take another 2-4 weeks after the successful evaluation.

Factors that Can Affect the Timeline:

• Completeness of the Application: If the application is thorough and all required documents are submitted correctly, the process may be faster.
• Complexity of the Device: Devices that require more detailed clinical data or a comprehensive risk management process may require additional time for review.
• Requests for Additional Information: If HSA requires additional information or clarification, the timeline can be extended.
• Device Classification Changes: If HSA reassesses the device classification or requires further testing or validation, this could lead to additional delays.

In Summary:

On average, it takes about 3 to 6 months to complete the Class C medical device registration process with HSA, but the exact timeline can vary depending on the factors mentioned.

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