After applying for D-class medical device registration with the Health Sciences Authority (HSA) in Singapore, you must adhere to various regulations and requirements to ensure compliance with both pre-market and post-market responsibilities. These obligations continue throughout the device's lifecycle, from approval to market surveillance.

1. Compliance with the Health Products Act (HPA) and Medical Device Regulations

• The primary regulations governing medical devices in Singapore are the Health Products Act (HPA) and the Medical Device Regulations (under the HPA).
• Once your device is registered, it must comply with the provisions set out in these regulations, including:
  • Ongoing adherence to safety and performance standards.
  • Ensuring the device continues to meet the risk classification and requirements for post-market surveillance.

2. Post-Market Surveillance (PMS) Requirements

• Continuous Monitoring: You must monitor the safety and performance of your medical device after it has been approved and placed on the market.
• Post-Market Surveillance Plan: A robust PMS plan should be in place, which should include mechanisms for:
  • Collecting user feedback.
  • Tracking adverse events.
  • Monitoring product failures or safety issues.
• Periodic Reporting: Regular reports on the safety and performance of the device may be required by HSA, especially if new risks or issues arise.

3. Adverse Event Reporting and Vigilance

• Reporting of Adverse Events: You must have a system in place to capture and report any adverse events or device defects. The Vigilance System for medical devices requires:
  • Serious Adverse Events (SAEs) to be reported to HSA within 10 days of being identified.
  • Non-serious adverse events should be reported according to the required timelines.
• Corrective Actions: If an issue is identified, corrective actions, such as device recalls, modifications, or changes to the Instructions for Use (IFU), should be implemented and reported to HSA.

4. Device Recall Procedures

• If safety or performance concerns arise, or if defects are discovered, a device recall may be necessary. You should:
  • Follow the prescribed recall procedures and notify HSA immediately.
  • Communicate with users and distributors about the recall process and any necessary actions.
  • Submit a final report detailing the corrective actions taken during the recall.

5. Annual Renewal of Registration

• The medical device registration is typically valid for 5 years from the date of approval.
• Before the registration expires, you must apply for renewal to maintain the validity of the device’s registration in Singapore.
• Recertification may be required as part of the renewal process to ensure continued compliance with regulatory standards.

6. Manufacturing and Quality Control Compliance

• The manufacturer must maintain compliance with Good Manufacturing Practice (GMP) and relevant quality standards (e.g., ISO 13485) to ensure consistent product quality.
• Routine Inspections: HSA may perform inspections to verify that manufacturing practices align with GMP standards. Keep all manufacturing and quality control records up-to-date and ready for inspection.
• Audit and Surveillance: You must be prepared for audits from HSA or third-party auditors to ensure that the product continues to meet the regulatory requirements.

7. Labeling and Instructions for Use (IFU) Compliance

• If any changes are made to the device or its intended use, labeling and Instructions for Use (IFU) must be updated accordingly.
• HSA must approve any changes to labeling that involve significant modifications to the device’s risk profile, intended use, or other critical aspects.

8. Maintain Accurate and Up-to-Date Documentation

• Keep a complete technical file and clinical data available to demonstrate that the device continues to meet regulatory standards.
• Ensure that any changes made to the device (e.g., modifications or upgrades) are documented, and updated versions of risk management documents, clinical data, and product specifications are kept.

9. Post-Market Clinical Follow-Up (PMCF) (If Applicable)

• For high-risk devices, the HSA may require you to conduct Post-Market Clinical Follow-Up (PMCF) studies to gather ongoing clinical evidence of the device’s long-term safety and performance.
• Clinical Trials: If necessary, you must perform additional clinical trials or studies to support the ongoing safe use of the device in the market.

10. Compliance with Advertising and Promotional Regulations

• Any advertising or promotion of the medical device must comply with HSA’s guidelines and cannot make unsubstantiated claims.
• Ensure that marketing materials are truthful and not misleading, and do not promise outcomes that the device cannot achieve.

11. Compliance with International Standards (if applicable)

• If the device is also marketed internationally, ensure that it continues to meet the international regulatory standards (such as CE marking, FDA approval, etc.).
• Any changes to international standards or new regulatory requirements in other markets may impact your device's registration status in Singapore.

12. Reporting of Device Defects and Safety Risks

• If any device defects or safety risks emerge during the post-market phase, you must:
  • Notify HSA promptly.
  • Provide necessary updates or modifications to the device or its labeling to mitigate any risks.
  • Take corrective actions as needed, including device recalls if required.

Summary of Regulations and Requirements to Follow After D-Class Medical Device Registration in Singapore:

1. Health Products Act (HPA) Compliance: Continue compliance with HPA and Medical Device Regulations.
2. Post-Market Surveillance (PMS): Monitor device safety and performance and report to HSA.
3. Adverse Event Reporting: Report adverse events promptly and take corrective actions.
4. Device Recall Procedures: Implement recalls if necessary and notify HSA.
5. Annual Renewal: Apply for device registration renewal before expiration.
6. GMP and Quality Control: Maintain compliance with GMP and ensure consistent product quality.
7. Labeling and IFU Compliance: Update labeling and IFUs in case of changes and obtain approval from HSA.
8. Maintain Documentation: Keep all technical and clinical documentation up-to-date.
9. Post-Market Clinical Follow-Up (PMCF): Conduct PMCF studies if required.
10. Advertising Regulations: Ensure all promotional materials comply with HSA’s guidelines.
11. International Compliance: Maintain compliance with international standards if marketing outside Singapore.
12. Defect and Safety Risk Reporting: Report any device defects or safety risks and take necessary corrective actions.

By adhering to these regulations and requirements, you ensure that your D-class medical device remains compliant with HSA’s regulatory framework and continues to be safe and effective for users in Singapore.

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