After the approval of Class I medical device MDACS registration in Hong Kong, there are several important considerations and ongoing obligations that manufacturers and distributors must be aware of to ensure continued compliance with local regulations.

Key Points to Note After MDACS Registration Approval

1. Post-Market Surveillance

• Ongoing Monitoring: Once your device is approved and registered, you are required to implement a post-market surveillance (PMS) system to monitor the performance and safety of the device once it is in the market.

• Incident Reporting: If any adverse events or safety incidents occur, they must be reported to the Department of Health (DH) as part of your obligations under post-market surveillance.

• Corrective Actions: If issues are detected, corrective and preventive actions (CAPA) may need to be taken to address any safety concerns or quality issues.

2. Updating Device Information

• Device Changes: Any significant changes to the device (e.g., design, materials, intended use, manufacturing process, labeling) after registration must be reported to the Department of Health. You may need to submit an amendment to your original registration.

• Labeling Updates: If there are updates to the labeling or instructions for use (IFU), they must be in compliance with the regulatory standards, and you need to ensure the updated labeling is registered with the DH.

3. Renewal of Registration (If Applicable)

• Validity Period: While Class I devices typically do not require frequent re-registration, it’s essential to check the validity of your registration status with the Department of Health. If there are changes to regulations or standards, it may require revalidation of your device's compliance.

• Re-registration Process: Although Class I devices usually have a simple renewal process, be aware of any updates to regulatory requirements that may affect the re-registration.

4. Importation and Distribution Requirements

• Local Responsible Person (LRP): If the manufacturer is based outside Hong Kong, they must have a Local Responsible Person (LRP) registered in Hong Kong. The LRP will act as the point of contact for the Department of Health and may need to handle any regulatory matters or communication with DH.

• Importation Compliance: Ensure that your importation of the medical device continues to comply with Hong Kong's regulations. If there are any changes in the supply chain, distribution processes, or parties involved, ensure that the Department of Health is informed as needed.

5. Corrective and Preventive Actions (CAPA)

• In the case of any safety concerns, device malfunctions, or customer complaints, you must implement corrective actions to address the root causes of the issue. You should also take preventive actions to minimize the likelihood of recurrence.

• Keep detailed records of the actions taken and report them to the Department of Health if necessary.

6. Adverse Event Reporting

• Incident Reporting: Any adverse events related to your device should be reported to the Department of Health according to the required timelines and processes. These could include:

  • Serious incidents (e.g., death or severe injury) related to the device.

  • Device defects or problems that compromise safety.

• Ensure that your adverse event reporting system is in place and functioning effectively to handle any reports from users or healthcare providers.

7. Continuous Compliance with Standards

• Adhere to Relevant Standards: Even after approval, your device must continue to comply with ISO 13485, ISO 14971, and other relevant international standards.

• Quality Assurance: Regular internal audits and inspections of your quality management system (QMS) should be conducted to ensure ongoing compliance with regulatory requirements.

8. Regulatory Updates and Notifications

• Stay Updated on Regulatory Changes: Medical device regulations in Hong Kong may evolve, and it is important to keep up to date with any changes to the Medical Device Ordinance (Cap. 599), MDACS, or other local regulations that could affect your device’s registration status.

• Notifications: Be aware of any requests from the Department of Health for information, audits, or inspections as part of ongoing regulatory oversight.

9. Export and Marketing

• Exporting Devices: If you plan to export your device to other countries, ensure that the device complies with the regulatory requirements of those markets, including CE marking for the EU, FDA clearance for the US, or other certifications for specific regions.

• Promotional Materials: Ensure that any marketing or promotional materials for the device are compliant with local advertising regulations. Avoid making unsupported medical claims about the device.

Summary Checklist After MDACS Registration Approval

1. Post-market surveillance and reporting (including adverse events).

2. Device updates: Notify DH of any significant changes.

3. Re-registration or renewal (if required).

4. Maintain LRP (if applicable) for overseas manufacturers.

5. Corrective and preventive actions as needed.

6. Incident and adverse event reporting.

7. Ongoing compliance with relevant standards (ISO 13485, ISO 14971, etc.).

8. Stay updated on regulatory changes.

9. Ensure proper distribution and export practices.

By meeting these ongoing obligations and ensuring continued compliance with Hong Kong’s medical device regulations, you can maintain the safety and effectiveness of your Class I device in the market.

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