After applying for A-class medical device registration with the Health Sciences Authority (HSA) in Singapore, there are several key rules and requirements that must be followed to ensure compliance with the regulatory framework. These rules cover a range of areas from post-application monitoring to device launch and ongoing regulatory obligations. Here are the key aspects you should keep in mind:

1. Notification of Any Changes to the Application

• Updates to the Device Information: If there are any significant changes to the device after submission but before approval (e.g., modifications to the device design, intended use, or manufacturing processes), you must notify HSA promptly.
• Update Application: In case of changes in the manufacturer’s details, authorized representative, or other important aspects of the application, you must submit updated documentation and seek approval if required.
• Withdrawal of Application: If you decide to withdraw your application during the review process, you must formally notify the HSA.

2. Response to Queries or Requests from HSA

• Addressing Additional Information Requests: During the review process, HSA may request additional documentation or clarification of certain aspects of your application. It's important to provide this information in a timely and accurate manner.
• Communication with HSA: Maintain good communication with the HSA throughout the application process. If needed, request clarification on any aspects of the application process or requirements.

3. Post-Approval Obligations

After receiving approval for the A-class medical device, you must comply with the following ongoing obligations:

4. Registration Maintenance

• Annual Registration Fees: You may be required to pay annual fees for maintaining the registration of the device. Ensure that fees are paid promptly to avoid suspension or withdrawal of registration.
• Device Listing: The device will be listed in the Singapore Medical Device Register (SMDR). You must ensure that the device remains in compliance with HSA regulations throughout its lifecycle.

5. Labeling and Packaging

• Compliance with Labeling Regulations: Ensure that your product labels and packaging continue to meet HSA’s labeling requirements. This includes:
  • Accurate device name, description, and intended use.
  • Manufacturer’s name and address.
  • Required symbols and warnings.
  • Batch or serial number (for traceability).
• Changes in Labeling: If any changes are made to the labeling or packaging (e.g., new claims, changes to instructions for use), these must be reported to HSA and updated accordingly. Some minor changes may not require prior approval, but major changes might require submission for review.

6. Adverse Event Reporting and Post-Market Surveillance

• Adverse Event Monitoring: Even for A-class devices, you must establish and maintain a post-market surveillance system. This includes monitoring the safety and performance of the device once it is in the market.
• Report Adverse Events: If any adverse events, complaints, or device failures occur, you must report them to HSA. Serious adverse events should be reported within 15 calendar days.
  • Incident reporting should be done through HSA’s Vigilance System.
  • Implement corrective actions when necessary, such as recalls or modifications to the device.

7. Corrective and Preventive Actions (CAPA)

• Field Safety Corrective Actions (FSCA): If post-market surveillance identifies safety or performance issues, you may need to implement corrective actions, such as:
  • Device recalls.
  • Safety warnings or public notices.
  • Product redesigns or modifications.
• These actions should be documented and communicated to HSA.

8. Inspection and Audits

• Manufacturing Facility Inspections: Although A-class devices are lower risk, HSA may still perform routine inspections of your manufacturing facility to ensure compliance with Good Manufacturing Practices (GMP) and ISO 13485 standards.
• Regulatory Inspections: If issues arise during the post-market phase (such as adverse events or complaints), HSA may conduct an audit or inspection of your facilities or records.
• Audit Preparation: Be prepared to provide access to relevant records, including design documentation, manufacturing processes, and any corrective actions taken.

9. Risk Management and Monitoring

• Ongoing Risk Assessment: Continually assess the risks associated with your device even after market approval. Regularly update the risk management file (per ISO 14971), including any new risk data gathered during post-market surveillance.
• Periodic Risk Analysis: Conduct periodic risk assessments and incorporate any findings into the ongoing safety and performance monitoring of the device.

10. Authorized Representative Responsibilities

• If the manufacturer is located outside Singapore, the authorized representative in Singapore must ensure that all regulatory requirements are met. This includes:
  • Compliance with post-market surveillance and adverse event reporting.
  • Communication with HSA on behalf of the manufacturer.
  • Maintaining records of the device and its regulatory status.

11. Changes to Manufacturing or Distribution

• Notify HSA of Changes: If there are any significant changes in the manufacturing process, device design, or intended use, HSA must be notified. Changes that may impact the safety or performance of the device may require re-submission or re-evaluation.
• New Manufacturing Sites: If the manufacturing site changes, or if the device is transferred to another site, HSA must be informed, and the new site may be subject to an inspection or assessment.
• Importation and Distribution: Ensure that your authorized distributor in Singapore is properly registered with HSA and complies with the relevant regulations for importing and distributing medical devices.

12. Compliance with International Standards

• Maintain Compliance with Standards: Ensure ongoing adherence to relevant international standards such as ISO 13485 and ISO 14971. HSA may request proof of compliance with these standards during audits or inspections.
• Document Changes to Compliance: If there are any changes to the international standards your device complies with (e.g., new updates to ISO standards), update your technical documentation and inform HSA if necessary.

13. Handling Device Recalls

• Recall Procedures: If a recall is initiated (due to safety concerns or non-compliance), you must:
  • Notify HSA immediately.
  • Implement a field safety corrective action (FSCA) plan.
  • Ensure the device is removed from the market or users' hands and that customers are informed.
• Documentation: Record and report all actions taken during a recall, including details of the affected units, reasons for recall, and actions taken to rectify the situation.

14. Device Exportation

• If you plan to export the A-class medical device to other countries, ensure that you comply with the regulatory requirements of the destination countries. In some cases, the device may need to be re-registered in those countries or require additional certifications (e.g., CE marking for the European Union).

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