After applying for Class B medical device registration with the Health Sciences Authority (HSA) in Singapore, you are required to comply with several regulations and requirements throughout the process and once the registration is granted. These regulations are designed to ensure the continued safety, efficacy, and quality of the medical device once it is on the market, as well as to protect public health. Here’s an overview of the key regulations and requirements you must follow:

1. Regulatory Compliance During Application Process

While your application is under review, the following requirements must be met:

a. Accurate and Complete Documentation

• Ensure all the information submitted in the application is accurate, complete, and up-to-date. This includes the technical documentation, quality management system, clinical data (if applicable), risk management reports, labeling and Instructions for Use (IFU).
• If HSA requests additional information or documentation, respond promptly to avoid delays in the review process.

b. Submission of Supporting Documents

• Along with the application form, submit all supporting documents (e.g., ISO 13485 certificate, test reports, clinical evaluation reports, risk management documents). Ensure that these documents are in compliance with the required international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 14971 for risk management, etc.).

c. Fee Payment

• Ensure that the application fee is paid correctly and promptly via the Health Products Regulation System (HPRS). Failure to pay fees or improper payment may delay the registration process.

2. Post-Registration Compliance Requirements

Once your Class B medical device is successfully registered with HSA, several ongoing regulatory obligations apply:

a. Quality Management System (QMS) Compliance

• Maintain ISO 13485 Certification: Your QMS should continue to meet ISO 13485 requirements, ensuring that your manufacturing processes, post-market activities, and product quality are consistently monitored and controlled.
• Regular Audits: HSA may require you to undergo periodic audits or inspections to ensure ongoing QMS compliance. Be prepared for unannounced inspections or to provide access to records as requested.

b. Post-Market Surveillance (PMS)

• Monitor Device Performance: After market entry, you are responsible for tracking the safety, performance, and effectiveness of the medical device. This includes maintaining vigilance over the device’s usage in real-world settings and addressing any issues promptly.
• Adverse Event Reporting: If any adverse events (e.g., device malfunction, injury, or death) related to the device occur, you must report these incidents to HSA.
  • Serious adverse events should be reported within 10 working days of becoming aware.
  • Non-serious adverse events can typically be reported on a quarterly basis, depending on HSA's requirements.
• Field Safety Corrective Actions (FSCAs): If necessary, take corrective actions, including issuing recalls or updates to the device. If you initiate a recall or a field safety action, you must inform HSA immediately and follow the required procedures.

c. Device Traceability and Records

• Maintain Traceability: Ensure that you can trace the device through the supply chain from manufacturing to distribution. This is critical for recall management and post-market surveillance.
• Document Retention: Retain records related to manufacturing, distribution, testing, and adverse events for a minimum of 5 years (or longer if required by HSA). These records should be readily available for HSA inspection.

d. Periodic Safety Update Reports (PSUR)

• In some cases, HSA may require Periodic Safety Update Reports (PSURs). These reports summarize the safety and performance of the device, using data from post-market surveillance activities and clinical use.
  • Frequency of PSUR: The frequency and specific contents of PSURs will depend on the risk classification and nature of the device.

e. Labeling and Packaging Compliance

• Ensure Continued Labeling Compliance: The device labeling and Instructions for Use (IFU) should remain consistent with HSA’s labeling requirements. Any changes to the labeling (e.g., warnings, usage instructions) should be reviewed and approved by HSA if required.
• Adherence to HSA Guidelines: Ensure that the labels meet the ISO 15223-1 standard for symbols and the HSA Medical Device Guidelines for appropriate information. This includes language, storage conditions, expiry dates, warnings, contraindications, and device-specific requirements.

f. Adherence to Advertising and Promotion Rules

• Advertising Compliance: All advertisements, promotional materials, and marketing claims must comply with HSA regulations. Claims should be truthful, substantiated by evidence, and not misleading.
• Pre-Approval for Claims: HSA may require you to obtain approval for certain types of promotional claims before they can be used.

3. Ongoing Monitoring and Reporting

• Vigilance System: Implement and maintain a vigilance system that helps monitor device safety and ensures that any adverse events or product issues are promptly addressed. This system should track any feedback or complaints received from users and ensure that any action taken is documented and compliant with regulatory standards.
• Reporting Changes: If there are any significant changes to the device, such as design modifications, new indications, or changes in manufacturing processes, these changes must be reported to HSA.
  • Types of Changes: This includes changes in the device’s intended use, production process, materials, or labeling.
  • Approval for Changes: In some cases, HSA approval may be required before these changes can be implemented.

4. Regulatory Inspections

• Prepare for Inspections: HSA has the authority to conduct inspections of your manufacturing facilities and distribution channels. These inspections are conducted to ensure that your manufacturing processes, labeling, quality control, and post-market activities comply with regulatory standards.
  • Inspection Scope: Inspections may involve reviewing your QMS, production facilities, records, and post-market surveillance activities.
  • Corrective Actions: If non-compliance or discrepancies are found, HSA may require corrective actions. This could involve updating processes, procedures, or documentation.
• Non-Compliance Penalties: If you fail to meet HSA requirements after registration, you may face penalties such as fines, suspension, or even revocation of the device’s registration.

5. Renewal of Registration

• Timely Renewal: Registration for Class B medical devices is valid for 5 years. You must apply for renewal before the expiration of the registration. It’s recommended to start the renewal process at least 6 months before the expiration date to ensure sufficient time for HSA’s review and approval.
  • Renewal Process: Submit updated documentation, including Post-Market Surveillance data, adverse event reports, and any changes to the device (if applicable). The renewal application will be reviewed by HSA, and you may be required to provide additional information.

6. Importation and Distribution Compliance

• Good Distribution Practice (GDP): Ensure that all distribution activities are compliant with Good Distribution Practice (GDP), which includes storage, handling, and transportation requirements to ensure product quality is maintained.
• Authorized Representative: If the device is manufactured outside of Singapore, you must continue to work with your Authorized Representative (AR) who will act as the liaison between your company and HSA.

7. Maintain Record of Fees and Payments

• Track Fees: Ensure that you maintain accurate records of all fees paid to HSA, such as registration, renewal, and inspection fees, as these are part of the regulatory compliance process.

Summary of Ongoing Regulatory Requirements After Registration

1. Maintain compliance with ISO 13485 and your Quality Management System.
2. Conduct post-market surveillance and monitor adverse events.
3. Report serious adverse events to HSA within 10 working days and submit field safety corrective actions (FSCAs) when necessary.
4. Ensure labeling and packaging compliance and address any changes.
5. Adhere to advertising and promotion rules set by HSA.
6. Prepare for HSA inspections and follow up on corrective actions if necessary.
7. Submit Periodic Safety Update Reports (PSUR), if required.
8. Renew registration every 5 years and provide updated documentation.
9. Maintain good distribution practices and ensure traceability through the supply chain.
10. Document and track fees related to registration and inspections.

By adhering to these regulatory requirements, you can ensure the continued compliance of your Class B medical device in Singapore, safeguard public health, and maintain smooth operations within the Singaporean market.

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