After applying for B-class medical device registration under the Medical Device Administrative Control System (MDACS) in Hong Kong, several regulations and requirements must be followed to ensure ongoing compliance with local laws and maintain the device's safety and effectiveness. Below are the key regulations and post-registration requirements:

1. Adherence to Post-Market Surveillance (PMS) Regulations

Once the device is registered, a manufacturer or the authorized representative is required to establish a Post-Market Surveillance (PMS) system to continuously monitor the safety and performance of the device in real-world use.

Key PMS Requirements:

• Monitoring Safety and Performance: Regularly collect and assess information regarding the device’s performance and any risks associated with its use in the field.
• Trend Analysis: Continuously analyze data to identify patterns that may indicate device malfunctions, safety concerns, or potential adverse events.
• Complaint Handling: Set up a formal system for receiving, investigating, and responding to complaints from users or healthcare providers about the device.

2. Reporting Adverse Events (Vigilance Reporting)

As part of the MDACS vigilance system, it is mandatory to report certain adverse events that occur after the device has been marketed.

Key Vigilance Reporting Requirements:

• Serious Adverse Event Reporting: Report incidents where the device has contributed to serious injury, death, or poses a significant public health risk. These reports should be submitted to the Medical Device Control Office (MDCO).
  • Timelines for Reporting: Serious events must be reported within 10 to 30 days, depending on the severity of the issue. Serious incidents typically must be reported within 10 days, while less critical incidents may have up to 30 days for reporting.
• Field Safety Corrective Actions (FSCA): If the device is found to pose an unacceptable risk, the manufacturer must take corrective actions such as recalling the product or updating user instructions. The MDCO must be notified of these actions immediately.

3. Maintain Compliance with Quality Management Systems (QMS)

Compliance with ISO 13485 for Quality Management Systems (QMS) is crucial both before and after MDACS registration. You must continuously maintain and update your QMS to reflect the latest regulatory requirements and ensure that your device meets safety and performance standards throughout its lifecycle.

Key QMS Requirements:

• Internal Audits: Conduct regular internal audits to ensure that all processes related to the design, manufacturing, and distribution of the device are compliant with ISO 13485.
• Document Control: Keep records of all technical documentation, complaints, non-conformities, and post-market surveillance activities. These records must be accessible for review in case of inspections or audits by the MDCO.
• Continuous Improvement: Implement corrective and preventive actions (CAPA) based on the data gathered through post-market surveillance and complaint handling.

4. Device Modifications and Change Notifications

If any significant changes are made to the B-class medical device post-registration, these must be reported to the MDCO, especially if the changes impact the device's safety, performance, or intended use.

Key Requirements for Device Changes:

• Report Significant Modifications: Submit a Change Notification if there are substantial changes to the device’s design, materials, intended use, manufacturing process, or labeling that could affect its safety or performance.
  • Examples of Significant Changes: Changes to critical components, introduction of new materials, or updates to sterilization methods would require MDCO notification.
• New Submission for Major Changes: If the change is deemed significant enough to affect the classification or regulatory status of the device, a new registration submission may be required.

5. Labeling and Instructions for Use (IFU) Updates

Labeling and Instructions for Use (IFU) must be maintained to reflect any new information regarding the safe use of the device, as well as any post-market findings that may arise. The labeling must comply with both ISO 15223 and MDACS guidelines.

Key Labeling Requirements:

• Updated Warnings and Precautions: If post-market surveillance or adverse events reveal new risks, the labeling and IFU should be updated to include additional warnings, contraindications, or precautions.
• Language Requirements: Ensure that all labeling and IFU materials are available in English and, where necessary, Chinese, as per Hong Kong’s regulatory requirements.

6. Product Recalls and Corrective Actions

In case a safety issue arises after the device is on the market, it may be necessary to initiate a product recall or other corrective actions. The MDCO must be informed of any corrective actions or recalls related to the device.

Key Recall Requirements:

• Voluntary Recalls: If safety concerns are identified, the manufacturer should take swift action to recall the device from the market and inform the MDCO and all relevant stakeholders.
• Field Safety Notices: Send out Field Safety Notices (FSNs) to healthcare providers and end users to inform them of the issues and any necessary actions they should take.
• Recall Coordination: Coordinate the recall with distributors and healthcare institutions to ensure that all affected units are accounted for and replaced or modified as needed.

7. Distribution and Traceability Records

Maintaining accurate records of the device’s distribution and traceability is essential for post-market surveillance and recall purposes. This is also important for ensuring compliance with MDACS regulations.

Key Record-Keeping Requirements:

• Device Traceability: Keep detailed records of the device’s batch numbers, manufacturing dates, and distribution networks to ensure traceability in case of product recalls or adverse event investigations.
• Distributor Records: Maintain updated records of all distributors, healthcare facilities, and other stakeholders involved in the supply chain.

8. Periodic Review of Clinical Data

For some devices, it may be necessary to perform ongoing clinical evaluations after the device is marketed to assess its long-term safety and performance. This is especially relevant for devices with limited clinical data at the time of approval.

Key Clinical Data Requirements:

• Post-Market Clinical Follow-Up (PMCF): For devices with limited pre-market clinical data or if new risks emerge, conduct post-market clinical follow-up studies to gather more real-world data on the device’s performance.
• Clinical Evaluation Updates: Update the Clinical Evaluation Report (CER) periodically with any new clinical evidence or data gathered from the post-market studies.

9. Keep Informed of Regulatory Changes

The MDACS system, along with other medical device regulations in Hong Kong, can be subject to updates. It's important to stay informed of any regulatory changes that may affect your device’s compliance status.

Key Actions:

• Monitor MDCO Announcements: Regularly check for updates from the MDCO on changes to regulatory requirements, guidance documents, or standards that could impact your device.
• Compliance with New Standards: If new standards or regulations are introduced, ensure that your device and its technical documentation are updated to reflect the latest requirements.

10. Registration Renewal and Maintenance

MDACS registration must be renewed periodically to maintain the device’s status on the market. Manufacturers or their authorized representatives are responsible for submitting renewal applications before the expiration of the device’s registration.

Key Renewal Requirements:

• Renewal Application: Submit the renewal application with any updated documentation, including post-market surveillance data, any changes made to the device, and a declaration that the device continues to meet the applicable regulatory requirements.
• Post-Market Surveillance Data: Provide a summary of the device’s performance, adverse events, and any recalls or corrective actions taken during the registration period.

Summary of Post-Application Regulations and Requirements

1. Post-Market Surveillance (PMS): Implement and maintain a system to monitor the device’s real-world performance and safety.
2. Adverse Event Reporting: Report serious adverse events and conduct corrective actions or recalls as necessary.
3. Maintain QMS Compliance: Continue adhering to ISO 13485 and keep your Quality Management System (QMS) up to date.
4. Device Modifications: Notify the MDCO of any significant changes to the device that could impact safety or performance.
5. Labeling and IFU Updates: Ensure that labels and instructions are regularly updated based on new information or risks.
6. Product Recalls: Be prepared to conduct recalls if safety issues arise, and keep the MDCO informed.
7. Distribution Records: Maintain accurate records of the device’s distribution to ensure traceability.
8. Clinical Data Reviews: Perform post-market clinical evaluations and update the Clinical Evaluation Report (CER) as needed.
9. Stay Current with Regulatory Changes: Regularly check for updates to MDACS regulations and ensure ongoing compliance.
10. Registration Renewal: Renew MDACS registration on time and provide updated documentation to maintain market approval.

By following these requirements, manufacturers can ensure continued regulatory compliance and device safety after registering a B-class medical device under the MDACS system in Hong Kong.

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