The processing time for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore can vary based on several factors, such as the complexity of the device, the completeness of the application, and whether additional information is required. However, as a general guideline:

Processing Time for D-Class Medical Device Registration:

• Typically, the processing time is around 90 calendar days (approximately 3 months) from the date of complete submission of the registration application.

Factors Affecting Processing Time:

1. Completeness of Application:

   • If the application is complete and meets all HSA requirements, the processing time may be closer to the 90-day target. However, if any required documents are missing or incomplete, this could delay the review process.

2. HSA's Request for Additional Information:

   • If HSA requires additional information, such as clarifications or further clinical data, this can extend the review time. You will be asked to respond to HSA's queries within a specified period.

3. Complexity of the Device:

   • For more complex D-class devices, which are typically high-risk devices like implantables or life-supporting devices, HSA may need more time to conduct a thorough review, especially if clinical trials or more detailed technical documentation are involved.

4. Inspection Requirements:

   • If an inspection of the manufacturing facility is required (for example, to verify compliance with Good Manufacturing Practices), this could add extra time to the overall process.

5. Backlog or Volume of Applications:

   • The volume of applications HSA is processing at any given time could also affect how quickly they are able to review and approve your application.

General Timeline:

• Complete application submission: ~90 calendar days for processing.
• Additional information requests or inspections: May extend the timeline by several weeks or months, depending on the nature of the request.

It is recommended to ensure that all required documentation is complete and submitted on time to avoid delays and facilitate a smooth registration process.

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