After obtaining Class C medical device registration with Singapore's Health Sciences Authority (HSA), manufacturers are required to maintain ongoing compliance with regulatory standards. Periodic updates and reporting ensure that the device continues to meet the necessary safety, efficacy, and quality standards throughout its lifecycle. Below are the periodic update standards and procedures you must follow for maintaining your device's registration with HSA:

1. Registration Renewal (Every 5 Years)

• Requirement: Medical device registration with HSA is valid for 5 years. Before the expiration date, you must apply for renewal to continue marketing the device in Singapore.
• Procedure:
  • Submit a Renewal Application: Before the expiration, submit a renewal application through the Health Products Portal (HPP).
  • Review of Documentation: Ensure that all documentation (e.g., clinical data, performance testing, safety information) is up to date, as HSA may request updated data during the renewal process.
  • New Information: If there have been significant changes to the device or manufacturing process, you must submit updated information to HSA for review.
  • Fees: Pay the renewal fee, which is required for the continuation of the registration.

2. Annual Post-Market Surveillance and Vigilance Reporting

• Requirement: Manufacturers must regularly monitor the safety and performance of the device after it is on the market and report any adverse events or safety issues.
• Procedure:
  • Vigilance System: Set up a post-market surveillance system to collect, analyze, and report any incidents involving the device (e.g., adverse reactions, malfunctions, recalls).
  • Adverse Event Reporting: As part of HSA's vigilance requirements, any adverse events (e.g., serious injuries, deaths, device defects) that occur with the device must be reported to HSA within 30 days of becoming aware of the incident.
  • Periodic Safety Updates: Depending on the device type, manufacturers may be required to submit Periodic Safety Update Reports (PSURs) or Periodic Benefit-Risk Evaluation Reports (PBRERs), especially if the device is used over an extended period or if it has been involved in any safety issues.

3. Product Changes and Updates

• Requirement: Any modification or change in the device, its components, labeling, or manufacturing process after the initial registration must be reported to HSA.
• Procedure:
  • Changes to Device: If there are any significant changes to the design, intended use, performance, or manufacturing processes, you must notify HSA and submit the updated documentation. HSA will assess whether these changes require a new registration or an amendment to the existing one.
  • Labeling Updates: If there are any changes to the labeling (e.g., new warnings, instructions for use), submit the updated labeling to HSA for approval.
  • Manufacturing Site Changes: If there are changes to the manufacturing site or processes, HSA may require inspections or additional documentation.
  • Clinical Data Updates: If new clinical data becomes available (e.g., new studies or post-market data), update your clinical evaluation report (CER) and submit it to HSA.

4. Post-Market Clinical Follow-up (PMCF)

• Requirement: Some Class C medical devices, particularly those with long-term usage or high-risk profiles, require ongoing clinical follow-up after market release.
• Procedure:
  • PMCF Plan: Develop and implement a Post-Market Clinical Follow-up plan, if applicable. This plan involves collecting and assessing data on the long-term safety and performance of the device.
  • Periodic Review of Data: Continuously review the collected clinical data to assess whether the benefit-risk profile of the device has changed.
  • Reporting: If any new risks or safety issues are identified during post-market surveillance or follow-up studies, report them to HSA immediately and provide corrective actions if needed.

5. Corrective Actions and Recalls

• Requirement: If your device is found to have defects, safety issues, or quality problems, HSA requires that corrective actions or product recalls be implemented.
• Procedure:
  • Corrective Actions: If a device defect or safety issue is identified, implement corrective actions such as device modification, enhanced labeling, or design changes to ensure safety.
  • Recalls: If necessary, initiate a device recall. Manufacturers must notify HSA immediately about any recalls or safety alerts, particularly if the device poses a significant risk to public health.
  • Root Cause Analysis: Perform an analysis of the root cause of the defect or safety issue, implement necessary changes, and submit a report to HSA.

6. Quality Management System (QMS) Updates

• Requirement: Manufacturers must ensure that their Quality Management System (QMS) remains in compliance with relevant standards throughout the lifecycle of the device.
• Procedure:
  • Regular Audits: Conduct internal audits to ensure the QMS is functioning effectively and is in compliance with HSA regulations and international standards (e.g., ISO 13485).
  • External Audits: Be prepared for HSA inspections or audits to verify ongoing compliance with regulatory requirements.
  • Continuous Improvement: Update and improve your QMS based on audit findings, complaints, and new regulatory changes.

7. Maintain Regulatory Compliance with Standards

• Requirement: Ensure that your device continues to meet the relevant international standards (e.g., ISO 14971, ISO 10993, ISO 13485) throughout its market lifecycle.
• Procedure:
  • Standards Updates: Stay updated on changes to international standards that may impact your device and ensure that your product remains in compliance with the latest version of applicable standards.
  • Certification Updates: If required, provide updated certificates of conformity to show ongoing compliance with international standards.

8. Documentation and Record-Keeping

• Requirement: Keep all records related to the device, including post-market surveillance, complaints, adverse events, and device changes, for at least 10 years.
• Procedure:
  • Data Retention: Ensure that all records are maintained and easily accessible for inspection by HSA or other regulatory authorities.
  • Compliance Audits: Be prepared for audits by HSA or other authorities, and ensure all necessary documentation is available.

Summary of Key Periodic Updates:

1. Renew the registration every 5 years with up-to-date documentation.
2. Submit periodic post-market surveillance reports, including vigilance reports on adverse events.
3. Notify HSA about significant changes to the device (e.g., design, manufacturing, labeling).
4. Implement a Post-Market Clinical Follow-up (PMCF) if required.
5. Corrective actions and product recalls must be immediately reported and addressed.
6. Maintain a Quality Management System (QMS) and conduct regular audits.
7. Ensure ongoing compliance with regulatory standards and updated certifications.
8. Retain all records for at least 10 years for future inspections.

By adhering to these periodic update standards and procedures, you can ensure that your device remains in good standing with HSA and continues to meet safety and efficacy requirements throughout its lifecycle in Singapore.

Let me know if you need further details on any of these steps!