To apply for Class C medical device registration with the Health Sciences Authority (HSA) in Singapore, you must follow a series of steps, which are outlined below:

Step-by-Step Process for Class C Medical Device Registration:

1. Preparation Before Application

Understand the Classification:

• Ensure that your device is correctly classified as Class C. Class C devices are considered medium to high risk, which typically include implantable devices or those that come into direct contact with critical parts of the body.

Appoint a Local Authorized Representative (LAR):

• If the manufacturer is located outside Singapore, you must appoint a Local Authorized Representative (LAR) based in Singapore who will be responsible for communicating with HSA during the application process and ensuring regulatory compliance.

Gather Required Documents:

Prepare all the necessary technical and regulatory documentation for submission. Some common documents required include:

• Clinical Evaluation Report (CER)
• Risk Management Report and Risk Assessment (ISO 14971 compliance)
• Performance Testing Results (such as biocompatibility tests, safety testing)
• Manufacturing Information (including Good Manufacturing Practice (GMP) certificates)
• Labeling (including instructions for use, packaging details)
• Declaration of Conformity (for devices that are CE marked)
• Device Description (indications for use, device design)

Ensure Compliance with International Standards:

• Make sure your device complies with internationally recognized standards such as:
  • ISO 13485 (Quality Management System)
  • ISO 14971 (Risk Management)
  • ISO 10993 (Biocompatibility)
  • Relevant IEC or ISO standards for device safety and performance.

2. Create an Account on the Health Products Portal (HPP)

Register an Account:

• If you do not have an existing account, go to the Health Products Portal (HPP) (https://www.hsa.gov.sg) and create an account.

Log into the HPP Portal:

• Once you have created an account, log in to the portal where you will submit your application and track the progress.

3. Complete the Application Form

Fill in the Application Form:

• Complete the Class C medical device registration application form on the HPP portal.
• Provide details about your device, its intended use, classification, manufacturer, and the appointed Local Authorized Representative (if applicable).

Upload Documentation:

• Upload all the necessary documentation (clinical evaluation, risk management report, device description, performance testing results, etc.) via the Health Products Portal.

Pay Registration Fee:

• Pay the applicable registration fees, which can be done directly through the HPP portal. Ensure the payment is completed to avoid delays.

4. Submission and Initial Screening by HSA

Screening Process:

• HSA will perform an initial check to ensure that the application is complete and that all required documents are uploaded.
• If there are any issues, such as missing or incomplete documents, HSA will contact you to rectify them.

5. Detailed Technical Review

Evaluation by HSA:

• Once the application passes the initial screening, HSA will begin the detailed technical evaluation.
• HSA will review the device’s clinical data, safety and performance testing, risk management, and labeling.

Possible Requests for Additional Information:

• If HSA needs further clarification or additional information, they may request it from you. Be prepared to respond promptly.

6. Final Decision and Registration

Approval:

• If the application meets all requirements and HSA is satisfied with the documentation, the Class C medical device will be approved.

Issuance of Registration Certificate:

• Upon approval, HSA will issue a registration certificate for the device, which allows you to market the device in Singapore.

7. Post-Market Surveillance and Compliance

Ongoing Obligations:

• After obtaining the registration certificate, you must adhere to post-market surveillance requirements, including:
  • Reporting adverse events
  • Device recalls, if necessary
  • Periodic updates on clinical data or performance
  • Renewal of registration (usually every 5 years)

Key Considerations:

• Registration Fees: Ensure that you have budgeted for the application fees, which vary depending on the device and its complexity.
• Timing: The overall registration process typically takes 3-6 months, depending on the completeness of the submission and any requests for additional information.

By following these steps and ensuring that your documentation is thorough, accurate, and compliant with HSA’s requirements, you can apply for and obtain Class C medical device registration in Singapore.

If you need help with specific aspects of the process or have further questions, feel free to ask!

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