Once MDACS (Medical Device Administrative Control System) registration for a Class IV in vitro diagnostic (IVD) medical device is approved in Hong Kong, there are several important considerations and ongoing responsibilities that manufacturers and stakeholders should be aware of. Here are key points to note after registration:

Post-Registration Considerations

1. Compliance with Regulatory Requirements:

   • Ensure continuous compliance with the Medical Device Ordinance (Cap. 663) and any specific conditions outlined in the registration approval.
   • Stay updated on any changes in regulations that may affect your device.

2. Post-Market Surveillance:

   • Implement a robust post-market surveillance (PMS) plan to monitor the device's performance and safety after it has been marketed. This includes:
     • Collecting and analyzing feedback from users.
     • Reporting any adverse events or incidents as per the MDCO guidelines.
     • Conducting periodic reviews of the device’s performance.

3. Adverse Event Reporting:

   • Establish procedures for reporting adverse events or serious incidents involving the device to the MDCO promptly.
   • Maintain records of all reported incidents and follow up with appropriate corrective actions if necessary.

4. Quality Management System (QMS) Maintenance:

   • Continue to maintain and improve your quality management system (QMS) in line with ISO 13485 or equivalent standards.
   • Conduct regular internal audits and management reviews to ensure ongoing compliance with QMS requirements.

5. Device Modifications:

   • If there are any changes or modifications to the device (e.g., design changes, manufacturing process changes), evaluate whether these changes require re-evaluation or re-registration with the MDCO.
   • Document any changes and their impact on the device's safety and effectiveness.

6. Labeling and Marketing Compliance:

   • Ensure that all marketing materials, labeling, and instructions for use (IFU) are accurate and reflect the device’s registered claims and intended use.
   • Make sure that any promotional claims are supported by evidence and comply with local advertising regulations.

7. Training and Education:

   • Provide training and support to healthcare professionals and users on the proper use of the device.
   • Ensure that users are aware of the device’s limitations and any safety precautions.

8. Record Keeping:

   • Maintain comprehensive records related to the device, including manufacturing records, quality control records, clinical data, and post-market surveillance data.
   • These records may be required for audits and inspections by regulatory authorities.

9. Periodic Regulatory Updates:

   • Stay informed about periodic updates and communications from the MDCO, as well as any new guidelines or standards that may apply to your device.

10. Periodic Reviews and Renewals:

    • Depending on the device and regulatory requirements, be aware of any periodic reviews or renewals of your MDACS registration that may be necessary.

Conclusion

By staying vigilant and proactive in managing post-registration responsibilities, manufacturers can ensure the ongoing safety and effectiveness of their Class IV in vitro diagnostic medical devices. This will not only help maintain compliance with regulatory requirements but also enhance the reputation and trustworthiness of the product in the market.

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