The cost and timeline for D-class medical device registration in Singapore with the Health Sciences Authority (HSA) can vary depending on several factors, such as the complexity of the device, the completeness of the application, and whether further clarification is required. However, here is a general outline based on HSA's standard procedures:

Cost of D-Class Medical Device Registration

The fees for registering a D-class medical device with HSA typically include:

1. Application Fee:
   • The application fee is required for the registration process and varies depending on the type of device and its classification.
   • For D-class devices, which are high-risk, the fee is generally higher than for lower-risk devices (A or B-class).
   • As of the latest available information, the application fee for D-class devices is approximately SGD 1,070 for initial registration.
2. Additional Costs:
   • Inspection Fees: If an inspection of the manufacturing facility is required by HSA, additional fees may apply. These fees are generally determined based on the scope of the inspection.
   • Quality Management System (QMS) Certification Costs: If you don’t already have ISO 13485 or another recognized QMS certification, the cost of obtaining one can be significant and should be considered as part of the overall registration cost.
   • Local Authorized Representative Fees: If you are a foreign manufacturer, you will need to appoint a Local Authorized Representative (AR) in Singapore, who may charge additional fees for handling the registration process and communication with HSA.

Timeline for D-Class Medical Device Registration

The timeframe for D-class medical device registration with HSA can vary, but typically it takes several months due to the more stringent review process for high-risk devices. The key stages in the timeline are as follows:

1. Preparation of Documents:

   • The preparation of the required documents, such as clinical data, risk assessments, manufacturing information, QMS certification, and labeling, can take several weeks to months, depending on how quickly you can gather and organize the required materials.

2. Submission:

   • Once all documents are prepared, they are submitted via the Medical Device Information and Communication System (MEDICS) portal.
   • The submission itself takes a relatively short amount of time (typically a few days), but the processing time depends on the completeness of the application and the type of device.

3. HSA Evaluation:

   • The review process for D-class medical devices is more thorough due to the high-risk nature of the device. This typically takes 3 to 6 months.
   • HSA will review the clinical data, manufacturing practices, risk management plans, and other submitted documents.
   • If HSA requires additional information or clarification, this can extend the evaluation period.

4. Approval and Issuance of Certificate of Registration (COR):

   • Once HSA has completed its evaluation, the registration is approved, and a Certificate of Registration (COR) is issued.
   • This step typically takes a few weeks once all requirements are met.

Total Estimated Time and Cost:

• Total Time: The entire process, from document preparation to approval, typically takes around 6 to 9 months for D-class devices, but this can vary depending on the complexity of the device and whether additional information is required.

• Total Cost: The application fee for D-class registration is around SGD 1,070, but additional costs for inspections, QMS certification, and Local AR fees may increase the total cost. The full cost will depend on your specific situation, such as whether you already have ISO certification or need to conduct clinical trials.

Key Considerations:

• Regulatory Review: Given the high-risk nature of D-class devices, HSA may request extensive documentation, particularly for clinical trials or specific technical aspects, which could lengthen the registration process.
• Post-Market Surveillance: Once registered, manufacturers must continue to meet post-market surveillance and reporting obligations, which may incur additional costs and require ongoing compliance efforts.

In summary, while the registration process for D-class medical devices in Singapore may take 6 to 9 months and cost approximately SGD 1,070 for the application fee, the total cost will depend on additional factors such as inspections and Local AR fees. Always ensure you have a clear understanding of the required documentation and timelines to streamline the process.