After applying for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, it is crucial to adhere to several regulations and requirements throughout the application process and after obtaining registration. Here’s a comprehensive overview of what must be followed:

Regulations and Requirements Post-Application

1. Adherence to the Medical Device Ordinance (Cap. 663):

   • Comply with the provisions outlined in the Medical Device Ordinance, which governs the registration, manufacture, and sale of medical devices in Hong Kong.
   • Ensure that your device remains classified correctly throughout its lifecycle.

2. Responding to Queries:

   • Be prepared to address any queries or requests for additional information from the Medical Device Control Office (MDCO) during the review process.
   • Ensure timely and comprehensive responses to avoid delays in the registration process.

3. Documentation and Record Keeping:

   • Maintain accurate records of all documentation submitted with your application, including any communications with the MDCO.
   • Document any changes made to the device or its manufacturing process after application submission.

4. Quality Management System (QMS) Compliance:

   • Continuously maintain and improve your quality management system in line with ISO 13485 or equivalent standards.
   • Conduct regular internal audits and management reviews to ensure compliance and address any non-conformities.

5. Post-Market Surveillance Plan:

   • Implement a post-market surveillance (PMS) plan to monitor the safety and effectiveness of the device after it is on the market.
   • Regularly collect and analyze data related to the device's performance, including user feedback and any reported adverse events.

6. Adverse Event Reporting:

   • Establish and follow procedures for reporting adverse events, serious incidents, or near misses associated with the device.
   • Report any incidents to the MDCO promptly, adhering to the specified timelines for reporting.

7. Labeling and Instructions for Use (IFU) Compliance:

   • Ensure that all labeling, packaging, and IFU materials remain compliant with regulatory requirements.
   • Any changes to labeling or IFU must be assessed for compliance and may require notification to the MDCO.

8. Changes to the Device:

   • Evaluate any changes or modifications to the device (e.g., design changes, manufacturing processes) to determine whether they require re-evaluation or re-registration with the MDCO.
   • Document the rationale for any changes and their impact on device safety and effectiveness.

9. Periodic Regulatory Updates:

   • Stay informed about updates, guidelines, or regulatory changes from the MDCO and other relevant authorities.
   • Adapt your practices as necessary to remain compliant with any new regulations.

10. Training and Education:

    • Provide ongoing training and support to healthcare professionals and users on the safe and effective use of the device.
    • Ensure that all staff involved in the manufacturing and distribution of the device are knowledgeable about regulatory requirements.

11. Monitoring Competence and Compliance:

    • Regularly assess the competence of personnel involved in the manufacturing, quality assurance, and regulatory affairs related to the device.
    • Maintain records of training, qualifications, and compliance with relevant standards.

12. Engagement with Regulatory Authorities:

    • Maintain open lines of communication with the MDCO and engage with them as needed for guidance or clarification on regulatory matters.

Conclusion

By adhering to these regulations and requirements after applying for MDACS registration for Class IV in vitro diagnostic medical devices, manufacturers can ensure ongoing compliance, enhance the safety and effectiveness of their devices, and build trust with regulatory authorities and users.

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