After obtaining Class III medical device MDACS registration in Hong Kong, there are several ongoing regulatory requirements and responsibilities that must be adhered to in order to maintain compliance and ensure the safety and performance of your medical device in the market. Below are the key regulations and requirements that must be followed:

1. Post-Market Surveillance (PMS)

• Monitor Device Performance: You must establish a post-market surveillance system to continually monitor the safety, effectiveness, and performance of the device once it is in the market.

• Adverse Event Reporting: Any adverse events, incidents, or problems related to the device must be reported to the Hong Kong Department of Health (DoH) promptly, in accordance with the Medical Device Adverse Event Reporting System.

• Periodic Safety Reports: You may be required to submit periodic safety updates or annual reports detailing the performance of the device, including any updates to risk management or clinical data.

2. Maintain Valid Registration

• Renewal of Registration: While Class III devices have a longer registration period than lower-class devices, you must ensure the MDACS registration remains valid. Some registrations may require periodic updates, and you must be aware of the renewal requirements, as they may vary.

• Changes to the Device: Any modifications or changes to the design, composition, labeling, or intended use of the device must be reported to the Department of Health. Significant changes may require a new registration or additional approval.

• Keep Registration Information Updated: Notify the Department of Health about any significant changes related to the manufacturer, authorized representative, device classification, or marketing.

3. Adherence to Labeling and Packaging Requirements

• Bilingual Labeling: Ensure that the device remains compliant with Hong Kong’s labeling requirements, which require both Chinese and English on the labels and instructions for use (IFU).

• Regulatory Information on Labels: Keep your registration number and other regulatory information clearly indicated on the labels, as required by MDACS.

4. Compliance with Quality Management Systems (QMS)

• ISO 13485 Compliance: Maintain compliance with ISO 13485, the international standard for Quality Management Systems (QMS) for medical devices. It is essential to continually meet these requirements and ensure proper documentation for quality control processes.

• Quality Audits: Be prepared for periodic audits by the Hong Kong Department of Health or external bodies to confirm ongoing compliance with quality management standards.

5. Regulatory Inspections

• Inspection by DoH: The Department of Health may conduct inspections of your manufacturing facilities, storage, and distribution practices to ensure compliance with Hong Kong’s medical device regulations.

• Supplier Audits: You may be required to audit your suppliers to ensure that they are providing compliant materials or components, particularly if you import or manufacture the device in Hong Kong.

6. Reporting of Field Safety Corrective Actions (FSCA)

• Corrective Actions: If there are safety issues or non-conformities related to your medical device, you must initiate Field Safety Corrective Actions (FSCA). This may include actions like recalls, device modifications, or changes to labeling and instructions.

• Notification to DoH: Any recall or corrective action must be reported to the Hong Kong Department of Health within a specified period. Additionally, you must notify affected parties, including healthcare professionals and distributors.

7. Vigilance System

• Reporting of Adverse Events: You must ensure that all serious adverse events or incidents related to the device are reported to the Department of Health in line with Vigilance Requirements.

• Continuous Monitoring: Continue to monitor the device for any safety signals or reports of failures in the field that may indicate the need for further investigation or action.

8. Distribution and Importation Compliance

• Distributor Responsibilities: If you are importing or distributing the device through third-party distributors, you must ensure that they are properly registered and authorized under Hong Kong regulations.

• Importation Requirements: Any imports of medical devices into Hong Kong should be done in compliance with Hong Kong’s customs regulations for medical devices.

9. Advertising and Promotional Materials

• Truthful Representation: Ensure that all advertising and promotional materials for the device are truthful and comply with regulations, avoiding any misleading claims about the device’s capabilities or performance.

• DoH Approval: Some promotional materials may require prior approval by the Department of Health, especially if they make claims related to the device’s medical benefits.

10. Safety and Performance Updates

• Clinical Updates: If there are new clinical data or studies that impact the safety or performance of the device, you must update your clinical evaluation report and submit this updated data to the Department of Health if required.

• Risk Management Updates: Continuous monitoring of any new risks associated with the device is required. If new risks are identified, update the risk management file accordingly.

11. Importer and Authorized Representative Responsibilities

• If you are an importer or have appointed a local Authorized Representative (AR), they are also responsible for ensuring ongoing regulatory compliance within Hong Kong.

• AR Responsibilities include maintaining the registration file, assisting with adverse event reporting, and coordinating the registration renewal process, as well as reporting any changes related to the device.

Key Considerations

• Documentation: Keep all regulatory documents, including registration certificates, testing reports, and post-market surveillance reports, up to date and readily available for review by authorities.

• Regulatory Changes: Stay informed about any changes in local regulations, as Hong Kong’s medical device regulatory framework may evolve over time, and adjustments to your practices may be necessary.

• Recalls and Safety Alerts: In case of any safety alerts or product recalls, be prepared to take swift action and coordinate with local authorities.

Summary of Post-Registration Obligations

1. Post-Market Surveillance: Continuously monitor device performance and report adverse events.

2. Maintain Valid Registration: Ensure registration is renewed, and changes to the device are reported.

3. Labeling Compliance: Adhere to bilingual labeling and regulatory requirements on the device.

4. Quality Management: Maintain ongoing compliance with ISO 13485 and QMS standards.

5. Regulatory Inspections: Be prepared for inspections and audits by DoH.

6. Corrective Actions: Implement field safety corrective actions and notify DoH of any recalls.

7. Adverse Event Reporting: Report serious adverse events to the DoH.

8. Distributor Compliance: Ensure distributors meet registration requirements.

By following these post-registration requirements and staying in compliance with Hong Kong's regulations, you will maintain a successful and regulatory-compliant product lifecycle for your Class III medical device.

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