The procedure for applying for Class C medical device registration with the Health Sciences Authority (HSA) in Singapore involves several steps to ensure that the device meets the necessary safety, performance, and quality standards. Below is a detailed step-by-step guide for applying for Class C medical device registration with HSA:

Step 1: Preparation for Application

Before submitting your application, you need to gather all necessary information and ensure that your device complies with HSA’s regulatory requirements. This includes:

• Ensure Compliance with Regulatory Standards: Your device must comply with the applicable international standards such as ISO 13485 (Quality Management), ISO 14971 (Risk Management), ISO 10993 (Biocompatibility), and any other relevant standards.

• Prepare Device Documentation: You will need to prepare comprehensive documentation, including:

  • Device Description and intended use
  • Clinical Evaluation Report (CER)
  • Risk Management Plan and Risk Assessment
  • Manufacturing Information
  • Device Testing Data (performance, safety, etc.)
  • Labeling and Instructions for Use (IFU)
  • Evidence of Compliance with Standards

• Establish a Local Authorized Representative (LAR): If the manufacturer is located outside Singapore, they must appoint a Local Authorized Representative (LAR) in Singapore who is responsible for communicating with HSA and ensuring regulatory compliance.

Step 2: Submit the Application

Once the necessary documentation is in place, submit your registration application through the Health Products Portal (HPP), the official online platform for medical device registration with HSA.

• Account Setup on Health Products Portal: You must create an account on the HPP if you don’t have one already. This is where the application, submission of documents, and payment will occur.
• Complete the Application Form: The online application form will request details about the device, the manufacturer, and its intended use. Make sure all the required fields are completed accurately.
• Submit Required Documents: Upload the necessary technical documentation, including the clinical evaluation report, risk management report, and any supporting documentation required by HSA.

Step 3: Application Review by HSA

After submission, HSA will begin its review process. The review typically includes:

• Initial Screening: HSA will first verify that the application is complete and meets the basic requirements. If there are missing or incomplete documents, they will request the applicant to submit the missing information.
• Technical Evaluation: HSA’s technical team will assess the device against regulatory standards, including the clinical data, safety, performance, and risk management information. This step is to ensure that the device is safe and effective for its intended use.
• Risk Classification Verification: HSA will verify that the device is correctly classified as a Class C medical device, based on its intended use and risk profile. Class C devices have moderate to high risks, so HSA ensures compliance with the applicable standards.
• Review of Labeling: HSA will review the device’s labeling to ensure it complies with Singapore’s labeling requirements (e.g., proper warnings, usage instructions, and language requirements).

Step 4: Further Requests (If Needed)

During the review process, HSA may request additional information or clarification regarding the device or application. This could include:

• Further Testing or Clinical Data: If the device is complex or high-risk, HSA may request additional clinical studies or testing data to support the application.
• Manufacturing Site Inspection: HSA may inspect the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP).
• Revisions to Documentation: If HSA identifies any issues with the submitted documentation (e.g., labeling, clinical evidence), they may request revisions before proceeding with approval.

Step 5: Approval and Registration

Once HSA is satisfied with the application and the supporting documentation:

• Issuance of Registration Certificate: If the device is approved, HSA will issue a registration certificate for the Class C medical device. This certificate allows the device to be marketed in Singapore.
• Payment of Fees: At this stage, the registration fee will be collected. The fee is due upon approval, and it must be paid before the registration certificate is issued.

Step 6: Post-Approval Obligations

After your device is registered with HSA, there are ongoing responsibilities and obligations:

• Periodic Reporting: You must comply with post-market surveillance and vigilance requirements. This includes submitting adverse event reports, post-market clinical follow-up data, and ensuring that the device continues to meet safety and performance standards.
• Renewal Application: Medical device registrations in Singapore are valid for 5 years. Before the registration expires, you must submit a renewal application to keep your device registered.

Step 7: Market Surveillance and Compliance

Once your Class C device is on the market, you must continue monitoring its performance and safety. This includes:

• Adverse Event Reporting: Notify HSA of any serious adverse events, product recalls, or safety issues related to the device.
• Compliance with Changes: If there are any changes to the device, manufacturing process, or labeling, you must notify HSA for approval.

Summary of Steps for Class C Medical Device Registration:

1. Preparation: Ensure compliance with relevant standards, prepare device documentation, and appoint a local authorized representative (if applicable).
2. Submit the Application: Register and submit the application and required documents via the Health Products Portal (HPP).
3. Application Review: HSA will review the submission for completeness, technical standards, and risk classification.
4. Further Requests: Address any requests for additional data or clarification from HSA.
5. Approval and Registration: Upon approval, receive the registration certificate and pay the applicable fees.
6. Post-Approval Obligations: Submit periodic safety and performance reports, and renew the registration every 5 years.
7. Market Surveillance: Monitor and report any safety issues, adverse events, or product recalls.

Following these steps ensures that the device meets all regulatory requirements for the safe and effective use of Class C medical devices in Singapore. Be mindful of HSA’s guidelines and timelines throughout the process.