The cost and time for applying for Class C medical device registration with Singapore's Health Sciences Authority (HSA) can vary based on factors like the complexity of the device and whether all required documentation is in order. Here is an overview of the expected cost and timeline for the application process:

Cost for Class C Medical Device Registration

The registration fee for Class C medical devices depends on the type and nature of the device. While the exact fee structure may be subject to updates, here are the typical components:

1. Application Fee:

   • For Class C devices, the application fee is typically higher than for Class A or B devices due to the more rigorous evaluation required for medium- to high-risk products.
   • Estimated Fee: The registration fee for a Class C medical device usually ranges from SGD 3,000 to SGD 5,000. This is a general range and could vary depending on the specific requirements for the device and its category.

2. Other Costs:

   • Additional Fees: If HSA requires an inspection of the manufacturing facility, there could be additional costs associated with this.
   • Consultant Fees: If you choose to work with a regulatory consultant to assist with the application, this could incur extra costs depending on the consultant's rates.
   • Post-Market Surveillance Fees: There may be fees for ongoing reporting, renewal applications (after 5 years), and other post-market activities.

Timeline for Class C Medical Device Registration

The timeline for registering a Class C medical device with HSA can vary, but the process generally takes several months due to the thorough evaluation required. Here's a typical breakdown of the timeline:

1. Preparation of Documents:

   • This step can take a few weeks to a few months depending on how prepared you are with the necessary documentation (clinical data, technical specifications, labeling, etc.).

2. Submission of Application:

   • Once the documentation is ready, the submission itself is relatively quick and can be completed within 1–2 weeks through the HSA's online portal.

3. HSA Review and Evaluation:

   • The review process for Class C devices is more detailed, as it involves clinical data and possibly manufacturing site inspections. This step usually takes between 3 to 6 months.
   • If HSA requests additional information or clarification, the timeline could extend further, depending on how quickly you can provide the requested data.

4. Approval and Registration:

   • Once HSA completes its evaluation, it typically issues a decision within 2 to 4 weeks. If approved, the device is registered for a period of 5 years.

5. Overall Timeline:

   • From the start of the application process to approval, the typical timeline for Class C medical device registration with HSA is 4 to 8 months.

Summary of Cost and Timeline

• Cost:
  • Application fee: SGD 3,000 to SGD 5,000 (approximately)
  • Other potential fees (consultant, inspection, post-market surveillance, etc.)
• Timeline:
  • Total time for registration: 4 to 8 months
  • Application submission: 1–2 weeks
  • HSA review and approval: 3 to 6 months (depending on complexity)

Additional Considerations:

• Regulatory Complexity: If the device requires a more detailed review or clinical data, the process may take longer.
• Documentation Readiness: Delays may occur if any required documentation is missing or needs to be revised.

If you have any other specific questions or need further clarification on any part of the process, feel free to ask!

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