Costs and Timeframes for Class B Medical Device Registration with HSA in Singapore

The costs and timeframes for applying for Class B medical device registration with the Health Sciences Authority (HSA) in Singapore depend on several factors, including the type of device and the specific regulatory requirements. Below are the general costs and timeframes involved in the registration process:

1. Registration Costs

The fees for Class B medical device registration with HSA are typically lower than those for Class C or D devices, but they can still vary depending on specific circumstances, such as the nature of the device and the application type.

Registration Fees

• Class B Medical Device registration fees are generally moderate, and can range from SGD 1,000 to SGD 2,000 per device, depending on the specifics of the device and whether it's a new device or a modification of an existing one.
• For Local Manufacturers: The fees for local manufacturers are typically lower than for foreign manufacturers, as the latter may need to account for additional verification and documentation costs.
• For Foreign Manufacturers: If a foreign manufacturer is applying, you may also incur additional costs for the appointment of a Local Authorized Representative (LAR), who will manage the registration process. The LAR typically charges a service fee, which can vary depending on the complexity of the device and the service provider.

Other Potential Costs

• Testing Fees: If your device requires additional testing (e.g., performance or biocompatibility testing), you may incur costs associated with third-party testing laboratories.
• Quality Management System (QMS) Certification: If you need to obtain or update a QMS certificate (e.g., ISO 13485), there will be associated costs for certification, audits, and maintenance.
• Consulting Fees: If you hire regulatory consultants to assist with the application process, this will also incur additional costs.

Fee Structure Summary:

• Class B registration fee: SGD 1,000 to 2,000 (approximately)
• Authorized Representative (LAR) fees: Varies, typically SGD 1,000 to 3,000 annually (if applicable)
• Other costs: Testing, consulting, certification fees may add up depending on device complexity.

For the most accurate cost estimate, you should check HSA’s official website or consult with an Authorized Representative or a regulatory consultant familiar with HSA’s fee structure.

2. Timeframes for Registration

The timeline for Class B medical device registration with HSA generally depends on the completeness of your application, the complexity of the device, and whether additional information is requested.

Typical Timeframe:

• Initial Review and Evaluation: Once the application is submitted, the HSA typically takes 1 to 3 months to evaluate the submission.
  • 1 Month: For straightforward applications with well-prepared documentation.
  • 3 Months: For more complex devices or when additional information is required.

If there are any issues with the submitted documentation (e.g., missing information, questions about risk management or clinical data), it could extend the evaluation time.

Factors Affecting Timeframe:

• Completeness of Documentation: If all required documents are submitted correctly, the review process will proceed more quickly. Incomplete or unclear submissions may result in delays as HSA may request further clarification or additional documents.
• Regulatory Complexity: Devices with higher complexity, such as those involving advanced technologies, clinical data, or unusual materials, may require more time for HSA to assess.
• Consultation with Experts: If necessary, HSA may consult with technical or clinical experts, which could extend the review time.

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