The processing time to obtain D-class medical device registration in Singapore through the Health Sciences Authority (HSA) typically takes 1 to 3 months. This time frame can vary depending on several factors, such as:

Factors Affecting Processing Time:

1. Completeness of the Application: If all required documents are submitted correctly and completely, the process will generally be quicker. Incomplete or incorrect applications may require additional time to address the issues.
2. Device Complexity: Although D-class devices are low-risk, more complex devices may take longer for HSA to evaluate.
3. Workload at HSA: The time can also be affected by the volume of applications HSA is handling at any given time.
4. Additional Information Requests: If HSA requires additional information or clarifications during the review process, this can extend the processing time.

Typical Stages of the Review Process:

• Initial Review: HSA checks the completeness of the submitted application and documentation.
• Evaluation: HSA assesses the safety, performance, and regulatory compliance of the device based on the submitted documents.
• Approval/Issuance: If the device meets the regulatory requirements, HSA will issue a Certificate of Registration, allowing the device to be marketed in Singapore.

Conclusion:

On average, the process will take 1 to 3 months, but it is important to be prepared for potential delays if additional information or clarification is requested by HSA.

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