After Class II medical device MDACS registration is approved in Hong Kong, it is essential to comply with ongoing regulatory and post-market requirements to maintain the device’s compliance and ensure its continued safety and effectiveness. Below are key points to pay attention to after approval:

1. Post-Market Surveillance (PMS)

• Monitor device performance in the market through a structured post-market surveillance system.

• Track adverse events, complaints, or product defects reported by users or healthcare professionals.

• Document and report any adverse events that occur, as required by the Medical Device Control Office (MDCO), and take corrective actions when necessary.

• Ensure that any risks identified during post-market surveillance are addressed and that appropriate measures (e.g., product recalls, modifications) are taken.

2. Vigilance and Adverse Event Reporting

• As part of the post-market vigilance system, report any serious adverse events (SAEs) or unanticipated risks to the MDCO in accordance with Hong Kong's regulations.

• For Class II devices, you must report any serious injury or death related to the device, as well as any device defects that could lead to such events.

3. Periodic Renewals

• MDACS registration is typically valid for 5 years, after which the registration must be renewed to continue marketing the device in Hong Kong.

• Submit a renewal application to the MDCO before the expiry of the registration period, including any updated information about the device (e.g., changes in manufacturing, new clinical data).

• Ensure that your Quality Management System (QMS) is still compliant with ISO 13485 and other applicable standards at the time of renewal.

4. Maintain Compliance with Labeling Requirements

• Ensure that the device labeling remains compliant with the requirements outlined in the registration.

• Labels must continue to be in Chinese or English (or both) and must include all required information, such as the intended use, warnings, precautions, and manufacturer information.

• If there are any changes to the labeling (e.g., updated indications for use), this must be submitted to the MDCO for review and approval.

5. Quality Management System (QMS) Maintenance

• Ensure that your QMS continues to meet the requirements of ISO 13485 and other relevant standards.

• Regularly perform internal audits, document corrective actions, and ensure that all processes are functioning according to the established procedures.

• Keep up to date with regulatory changes that might impact your device, and make necessary adjustments to your QMS to maintain compliance.

6. Distribution and Importation Compliance

• If the device is imported, ensure compliance with Hong Kong's import regulations.

• Devices must be imported by a local distributor or the manufacturer’s authorized representative in Hong Kong, who is also responsible for maintaining regulatory compliance in the country.

• Ensure that proper importer documentation is kept up to date and available for inspections.

7. Recall Management

• Be prepared to recall your device from the market if safety issues are discovered, especially if a defect presents an imminent risk to public health.

• Have a structured process in place for handling recalls, including identifying the affected units, notifying customers, and retrieving the devices.

• Ensure that a root cause analysis is performed and corrective actions are taken to prevent further issues.

8. Reporting Changes to the MDCO

• Report any changes to the device or its manufacturing process to the MDCO. This includes:

  • Changes to device design.

  • Changes in manufacturing site or quality control procedures.

  • Modifications to labeling or intended use.

  • Introduction of new materials or components used in the device.

• Any changes may require additional review or amendments to the registration.

9. Maintain Records of Clinical Data

• Maintain accurate records of clinical trials, clinical evaluations, and any post-market clinical follow-up if applicable.

• If the device is used in clinical settings, ensure that updated clinical data is submitted to the MDCO if any new findings or reports arise.

10. Training and Support for Users

• Provide ongoing training and technical support to healthcare professionals and end users of the device.

• Ensure that the training addresses any updates or changes to the device and highlights potential safety concerns or best practices for use.

11. Exporting the Device

• If your device is exported to other markets, ensure compliance with the relevant regulatory requirements in those countries (e.g., CE marking for Europe, FDA clearance for the U.S., etc.).

• Document all international approvals and ensure that they remain valid.

By paying attention to these key aspects after Class II MDACS registration is approved, you can ensure continued compliance, monitor the safety and effectiveness of the device in the market, and address any emerging issues promptly.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn