After successfully obtaining Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, there are several key responsibilities and ongoing requirements that manufacturers and distributors must be aware of to maintain compliance with regulatory standards. These obligations ensure the continued safety, performance, and efficacy of the device in the market, as well as the manufacturer’s ongoing compliance with HSA regulations.

1. Post-Market Surveillance (PMS)

• Continuous Monitoring: Manufacturers are required to monitor the safety and performance of the device once it is on the market. This includes tracking adverse events and device-related issues that may arise after commercialization.
• Adverse Event Reporting: If any adverse events occur (such as a device malfunction, injury, or death related to the device), the manufacturer must report these events to HSA within the required timeframe. Typically, serious adverse events must be reported within 10 working days of becoming aware of the incident.
• Corrective Actions and Recalls: If any problems are detected, such as a defect or safety concern, the manufacturer must take corrective actions, which may include device recalls, modifications, or warnings. In cases of product recalls, the manufacturer must inform HSA promptly and follow the necessary procedures to ensure the safety of users.

2. Renewal of Registration

• Validity Period: The registration of a Class B medical device with HSA is valid for 5 years. Manufacturers must ensure that the registration is renewed before it expires to avoid any disruption in the product's market availability.
• Renewal Requirements: To renew the registration, manufacturers must submit updated documentation to HSA, which may include:
  • Confirmation of continued compliance with applicable standards.
  • Post-market surveillance data (e.g., reports of adverse events or safety updates).
  • Any changes to the device’s design, intended use, labeling, or manufacturing processes.
• Timely Renewal: It’s advisable to start the renewal process at least 6 months before the expiration date to ensure adequate time for submission, review, and approval.

3. Changes to the Device

• Notifying HSA of Changes: If there are any significant changes to the device, such as modifications to its design, materials, intended use, or manufacturing process, the manufacturer must notify HSA and may need to submit an updated registration. Such changes may include:
  • Modification of device labeling or instructions for use (IFU).
  • Changes to manufacturing processes or facilities.
  • Addition of new clinical indications or intended uses.
• Supplementary Submission: In some cases, changes might require the submission of new documentation, including updated clinical evaluation reports, risk management assessments, or performance testing data.

4. Distribution and Marketing

• Good Distribution Practice (GDP): Manufacturers and distributors must adhere to Good Distribution Practice (GDP) requirements, which ensure the device is safely stored, handled, and transported to maintain its quality and integrity.
  • GDP Guidelines: This includes appropriate labeling, storage conditions, transport methods, and record-keeping to track devices in the supply chain.
• Authorized Representative: If the manufacturer is located outside Singapore, they are required to appoint an Authorized Representative in Singapore who is responsible for the device’s compliance with local regulations and HSA requirements.

5. Labeling and Instructions for Use (IFU)

• Accurate Labeling: Ensure that the device labeling, including the Instructions for Use (IFU), remains accurate and complies with local and international standards, such as ISO 15223-1 (for symbols) and ISO 13485 (for quality system requirements).
• Updates: If there are changes to the device or its use, the labeling and IFU must be updated accordingly. For example, if new safety information becomes available, warnings or contraindications must be revised.

6. Compliance with Advertising and Promotion Rules

• Advertising Guidelines: HSA has specific guidelines regarding the advertising and promotion of medical devices in Singapore. Manufacturers must ensure that all promotional materials (e.g., brochures, websites, and advertisements) comply with HSA’s requirements.
  • Claims made in advertising must be truthful and substantiated, and should not mislead or misrepresent the device’s effectiveness.
• Pre-approval for Advertising: In some cases, certain promotional materials (especially those that make claims about the medical device’s clinical benefits) may need to be reviewed and approved by HSA before they can be used.

7. Vigilance and Reporting Obligations

• Vigilance System: Manufacturers must establish and maintain a vigilance system to monitor the safety of the device after it has been marketed. This involves:
  • Regularly reviewing customer complaints and adverse event reports.
  • Monitoring scientific literature for any new information about the device’s safety or performance.
  • Reporting any serious incidents or field safety corrective actions (FSCAs) to HSA.
• Periodic Safety Update Reports (PSUR): In some cases, HSA may require manufacturers to submit Periodic Safety Update Reports (PSURs) that summarize the safety and performance of the device based on post-market data.

8. Regulatory Inspections

• HSA Inspections: HSA has the authority to conduct inspections of the manufacturer’s facilities and supply chain to ensure ongoing compliance with regulatory requirements. Inspections may cover manufacturing processes, quality control, post-market surveillance activities, and adherence to safety regulations.
• Corrective Actions: If issues are identified during an inspection, HSA may require corrective actions to resolve any deficiencies. These actions must be implemented promptly to maintain the device’s registration.

9. Fees and Payments

• Annual Fees: While the registration fee for Class B devices is typically a one-time fee, manufacturers should be aware of any ongoing fees associated with maintaining the registration or renewing it.
• Penalties for Non-Compliance: Failing to comply with HSA’s post-market requirements, such as timely reporting of adverse events or failure to renew the registration, could result in penalties or even suspension of the device’s registration.

10. Record Keeping

• Document Retention: Manufacturers must maintain all records related to the device’s design, manufacturing, quality control, and post-market surveillance for a specified period (usually 5 years or more). These records must be readily available for inspection by HSA if requested.
• Traceability: Ensure that devices are traceable through the supply chain from manufacturing to distribution and use. This includes maintaining records of batch numbers, lot numbers, and distribution details.

Summary: Key Post-Registration Responsibilities

1. Post-market surveillance: Monitor device performance, report adverse events, and take corrective actions if needed.
2. Registration renewal: Ensure timely renewal of registration (every 5 years).
3. Changes to the device: Notify HSA and submit updated documentation for any significant device modifications.
4. Distribution and labeling: Ensure compliance with GDP guidelines and keep device labeling up to date.
5. Advertising compliance: Follow HSA’s rules for device advertising and promotional claims.
6. Vigilance system: Maintain a system for monitoring safety and performance post-market and submit necessary reports (e.g., PSURs).
7. Regulatory inspections: Be prepared for HSA inspections and address any non-compliance issues promptly.
8. Record-keeping: Maintain records and documentation as required by HSA.

By adhering to these post-registration requirements, manufacturers can ensure the continued compliance of their Class B medical devices in Singapore and contribute to patient safety and device efficacy in the market.