The process for applying for Class C medical device registration with the Health Sciences Authority (HSA) in Singapore involves several key steps to ensure that the device complies with HSA's regulatory requirements. Here's an overview of the process:

1. Preparation of Application

Before submitting an application for Class C medical device registration, ensure that you are fully prepared:

Key Preparation Steps:

• Determine the Class of the Device: Ensure that your device is correctly classified as a Class C medical device, which is intended for medium to high-risk use. Devices in this category often require a more rigorous review process compared to Class A or B.

• Appoint a Local Authorized Representative (LAR) (if applicable):

  • If the manufacturer is located outside Singapore, they must appoint a Local Authorized Representative (LAR) in Singapore to communicate with HSA and ensure regulatory compliance.

• Ensure Compliance with International Standards:

  • Your device must comply with applicable international standards, such as:
    • ISO 13485 (Quality Management Systems)
    • ISO 14971 (Risk Management)
    • ISO 10993 (Biocompatibility)
    • Relevant IEC or ISO standards for performance and safety.

• Compile Required Documentation: The key documents required for Class C device registration include:

  • Clinical Evaluation Report (CER) that assesses the clinical evidence supporting the device’s safety and performance.
  • Risk Management Report and Risk Assessment.
  • Manufacturing Information (including GMP certificates, if applicable).
  • Device Testing Data (performance, safety, biocompatibility tests).
  • Labeling (including instructions for use and labeling details).
  • Declaration of Conformity for CE-marked devices (if applicable).
  • Device Description (including indications for use and design).

2. Submission of Application

Once you have the required documents, submit the application for Class C medical device registration via the Health Products Portal (HPP):

Submission Steps:

• Create an HPP Account: If you don’t already have an account, create one on the Health Products Portal (HPP) at HPP Portal.

• Complete the Online Application Form:

  • Provide information about the manufacturer, the device, its intended use, and the classification.

• Upload Required Documents: Submit the necessary technical documents as mentioned earlier. Ensure that all documents are complete and comply with HSA’s submission guidelines.

• Payment of Registration Fee: Pay the applicable registration fee via the Health Products Portal.

3. Initial Review by HSA

HSA will perform an initial screening to verify that all required documents have been submitted and meet regulatory requirements. The review includes:

Initial Screening Steps:

• Completeness Check: HSA will check that all documents are complete and the application is correctly filled out.
• Verification of Manufacturer’s Details: If the manufacturer is based outside of Singapore, the Local Authorized Representative (LAR) will be responsible for the submission and communication with HSA.

If HSA determines that the application is incomplete or documents are missing, they will notify the applicant for corrections or additional information.

4. Detailed Evaluation and Review

Once the initial review is complete, HSA will proceed with the technical evaluation of the application:

Evaluation Steps:

• Clinical Evaluation Review: HSA will assess the clinical data to verify that the device is safe and effective for its intended use.
• Risk Management and Safety Review: HSA will evaluate the device’s risk management processes, including compliance with ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility) for safety.
• Device Performance and Testing: HSA will review the performance testing, such as electrical safety (for electrical devices), mechanical safety, and any other relevant testing data.
• Manufacturing Compliance: Ensure that the device is manufactured according to Good Manufacturing Practices (GMP), and that manufacturing sites are compliant with HSA's requirements.

If necessary, HSA may request additional information or clarification during this review stage.

5. Decision and Registration Approval

If HSA is satisfied with the submission and all technical documents, the device will be approved for registration.

Approval Steps:

• Issuance of Registration Certificate: Upon approval, HSA will issue a registration certificate for the device, which allows it to be legally marketed in Singapore.
• Payment of Fees: Ensure that the registration fees are paid in full before receiving the certificate.

6. Post-Market Surveillance and Compliance

Once the Class C medical device is registered, you are responsible for ongoing monitoring and reporting:

Post-Approval Obligations:

• Adverse Event Reporting: Report any adverse events or device-related safety concerns to HSA.
• Post-Market Clinical Follow-up: Submit any post-market clinical data or follow-up reports if required.
• Annual Renewal: Medical device registration with HSA is valid for 5 years. Before expiration, a renewal application must be submitted.

Key Timelines:

• Initial Review: Typically takes 1-2 weeks.
• Detailed Evaluation: Generally takes around 4-6 weeks, but may take longer depending on the complexity of the device.
• Approval and Registration: After a successful review, the device is registered within 3-6 months.

Summary of the Process for Applying for Class C Medical Device Registration:

1. Prepare the Application: Gather all the necessary documentation, including clinical data, performance testing, and labeling.
2. Submit the Application: Complete the application and submit it via the Health Products Portal.
3. Initial Screening: HSA checks the completeness of your application.
4. Detailed Review: HSA evaluates the technical data, clinical evaluation, risk management, and safety.
5. Approval: If everything meets the requirements, HSA issues the registration certificate.
6. Post-Market Requirements: After approval, maintain post-market surveillance and ensure compliance with HSA regulations.

By carefully following these steps, you can ensure a smooth and successful registration process for your Class C medical device in Singapore.

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