For Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, periodic updates, adherence to standards, and established processes must be followed throughout the lifecycle of the device. These ensure ongoing compliance with regulatory requirements and the continued safety, efficacy, and performance of the device in the market. Below is a breakdown of the periodic updates, standards, and processes relevant to Class B devices:

1. Periodic Updates and Reporting Requirements

a. Periodic Safety Update Reports (PSUR)

• Purpose: The Periodic Safety Update Report (PSUR) provides a summary of the device's safety and performance over time. It is a key tool to evaluate if the device continues to meet safety and regulatory standards.
• When Required: Depending on the risk profile of the device and the duration since market entry, HSA may request PSURs. Class B devices, being moderate-risk devices, may require periodic updates to assess post-market safety data.
• Content of PSUR: A PSUR typically includes:
  • A summary of all adverse events, complaints, and device failures.
  • Data analysis on device performance and effectiveness in the real-world setting.
  • Any corrective or preventive actions (CAPA) taken.
  • Recommendations for future monitoring or adjustments to labeling.
• Frequency: The frequency of PSUR submission may vary. For Class B devices, it’s typically submitted annually or at intervals specified by HSA.

b. Post-Market Surveillance (PMS) Data Submission

• Requirement: Ongoing post-market surveillance (PMS) is essential to monitor the device's safety and effectiveness once it is available to end-users. This includes tracking adverse events, complaints, and device performance over time.
• Periodic Review: Regular reviews of PMS data must be conducted, and you may be required to submit updated PMS data to HSA. If significant issues or adverse events arise, you must report them to HSA promptly (as per adverse event reporting guidelines).
• HSA Monitoring: HSA will track the adverse events and review your post-market data to ensure continued safety. The authority may request additional investigations, updates, or corrective actions based on the information provided in your PMS reports.

c. Changes to the Device or Manufacturing Process

• Notifying HSA: If you make any changes to the device, its design, manufacturing process, labeling, intended use, or the Quality Management System (QMS), you must inform HSA and, in some cases, submit the changes for approval.
  • Significant changes that may impact the safety or effectiveness of the device require prior approval from HSA.
  • For minor changes, you may only need to submit a notification.
• Examples of Changes Requiring Notification or Approval:
  • Changes in device composition or materials (e.g., different biocompatible materials).
  • Modification of intended use or indications.
  • Update of Labeling and Instructions for Use (IFU) (e.g., safety warnings, new indications).
  • Introduction of new manufacturing sites or significant alterations to production facilities.

d. Annual Declaration of Conformity

• Annual Updates: Each year, you may be required to submit an Annual Declaration of Conformity to confirm that the medical device continues to comply with the relevant regulatory requirements.
• Content of Declaration: The declaration affirms that:
  • The device is still in compliance with HSA guidelines and relevant international standards (e.g., ISO 13485, ISO 14971).
  • The device has been subject to ongoing post-market surveillance and no new safety concerns have arisen.

2. Standards for Class B Medical Devices in Singapore

a. ISO 13485:2016 - Quality Management System (QMS)

• ISO 13485 provides the standard for quality management systems (QMS) specific to medical devices. Class B device manufacturers must establish and maintain a QMS that aligns with this standard.
• Ongoing Compliance: Ensure that your device production and post-market activities continue to meet ISO 13485 requirements. This includes regular internal audits, management reviews, and continuous improvement processes.

b. ISO 14971 - Risk Management

• ISO 14971 provides guidelines for risk management of medical devices. It covers the identification, evaluation, control, and monitoring of risks associated with the device.
• Ongoing Risk Management: You must maintain up-to-date risk management files that reflect any new risks identified during post-market surveillance or adverse event analysis. Regularly review and update the risk management process to ensure that all potential risks are mitigated appropriately.

c. ISO 10993 - Biocompatibility

• Devices that come into direct contact with the body must comply with ISO 10993, which outlines the requirements for biocompatibility testing. For Class B devices, biocompatibility is critical, and ongoing monitoring of materials may be required to ensure they are still safe for use.
• Update Biocompatibility Data: If there are changes in the materials used in your device, you may need to update your biocompatibility assessment and perform additional testing.

d. IEC 60601-1 - Safety and Performance of Medical Electrical Equipment

• If your Class B device is electrical, it must comply with IEC 60601-1, which defines safety and performance requirements for electrical medical devices.
• Ongoing Compliance: Ensure that the device meets electrical safety standards, and any updates or modifications to the device (e.g., electrical components) should be assessed against these standards.

e. Other Relevant International Standards

• Depending on the nature of your Class B device, other international standards may apply, such as:
  • IEC 62366 (usability engineering),
  • ISO 15223-1 (labeling requirements),
  • ISO 14155 (clinical investigations of medical devices), etc.
• Regularly review the latest editions of these standards to ensure that your device remains compliant.

3. Processes for Ongoing Regulatory Compliance

a. Post-Market Surveillance (PMS) Process

• Routine Monitoring: Establish a robust post-market surveillance process that includes:
  • Collecting user feedback, complaints, and adverse event reports.
  • Monitoring device performance in real-world conditions.
  • Analyzing trends in device malfunctions or adverse events.
• Corrective and Preventive Actions (CAPA): Based on post-market surveillance data, implement corrective and preventive actions when necessary. This may include revising the design, updating the labeling, or issuing recalls.

b. Adverse Event Reporting Process

• Timely Reporting: Report serious adverse events (SAEs) to HSA within 10 working days and non-serious events on a quarterly basis.
• Reporting Forms: Use the appropriate forms and systems provided by HSA to report adverse events, complaints, or device malfunctions.

c. Recall Process

• If a safety issue arises with the device, implement a recall and inform HSA promptly. The recall process involves:
  • Identifying affected devices.
  • Notifying distributors, healthcare providers, and patients.
  • Collecting and managing recalled products.
  • Correcting the root cause and preventing further issues.
• HSA will require you to submit a recall strategy, detailing how the recall will be handled.

d. Inspection and Audits

• Routine Inspections: HSA may conduct routine inspections of your manufacturing facilities, storage, and distribution channels to verify that your operations are in compliance with the standards.
• Self-Inspections: Conduct regular internal audits to evaluate your compliance with regulatory requirements and standards, ensuring that you identify any issues early.

e. Updates to Quality Management System (QMS)

• As part of ongoing compliance, ensure your QMS remains up-to-date with any changes to your device or processes. This includes regular reviews, updating documentation, and conducting internal audits.

f. Renewal of Registration

• 5-Year Renewal Cycle: Medical device registrations in Singapore are valid for 5 years. Before the registration expires, you must apply for renewal by submitting updated information about the device, including post-market surveillance data, any changes to the device, and compliance documentation.

Summary of Periodic Updates, Standards, and Processes

1. Periodic Safety Update Reports (PSUR): Annual or as specified by HSA.
2. Post-Market Surveillance (PMS): Ongoing monitoring and reporting of adverse events and device performance.
3. Compliance with Standards:
   • ISO 13485 (Quality Management),
   • ISO 14971 (Risk Management),
   • ISO 10993 (Biocompatibility),
   • IEC 60601-1 (Safety of Electrical Equipment).
4. Notifying HSA of Changes: Report any significant changes to device design, manufacturing, or labeling.
5. Adverse Event Reporting: Timely reporting of adverse events within 10 working days for serious events.
6. Recall Process: Promptly report and manage device recalls as required.
7. Periodic Inspections and Audits: Routine inspections and audits to ensure ongoing compliance. 

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