The process for MDACS registration of Class III in vitro diagnostic (IVD) medical devices in Hong Kong involves several critical steps. Below is a detailed outline of the registration process:

1. Pre-Application Preparation

• Understand Regulatory Requirements: Familiarize yourself with the MDACS registration guidelines and requirements specific to Class III IVD devices, as outlined by the Medical Device Control Office (MDCO).
• Determine Device Classification: Confirm that your device qualifies as Class III based on its intended use and associated risks.
• Develop Quality Management System (QMS): Establish a compliant QMS based on ISO 13485, ensuring all processes related to design, manufacturing, and post-market surveillance are documented and implemented.

2. Gather Technical Documentation

• Compile a Technical File: Prepare comprehensive technical documentation that includes:
  • Device description and intended use.
  • Design and manufacturing processes.
  • Risk management documentation in compliance with ISO 14971.
  • Clinical evidence demonstrating safety and efficacy.
  • Labeling and packaging information.

3. Application Submission

• Complete the MDACS Application Form: Obtain the application form from the MDCO website and fill it out thoroughly, providing all required information accurately.
• Prepare Application Package: Organize the application form and all supporting documents systematically, ensuring completeness and compliance with submission requirements.

4. Submit Application to MDCO

• Submit the Application Package: Submit the completed application package to the MDCO. This can typically be done through their designated submission portal or in person, depending on the guidelines.
• Pay Applicable Fees: Ensure that all necessary fees associated with the registration process are paid at the time of submission.

5. Review Process by MDCO

• Initial Screening: The MDCO will conduct an initial review of the application to ensure that all necessary information and documents are included.
• Detailed Assessment: The MDCO will perform a detailed evaluation of the technical documentation, including the assessment of clinical data, risk management files, and compliance with quality standards.
• Additional Information Requests: If required, the MDCO may request additional information or clarification from the applicant during the review process.

6. Approval or Rejection

• Notification of Outcome: Once the review is complete, the MDCO will notify the applicant of the outcome. If the application is approved, the device will be registered under the MDACS framework.
• Handling Rejections: If the application is rejected, the applicant will receive feedback regarding the reasons for rejection and may have the opportunity to address these issues and resubmit.

7. Post-Registration Obligations

• Implement Post-Market Surveillance: After approval, establish a post-market surveillance plan to monitor the device’s performance and safety once it is on the market.
• Adverse Event Reporting: Set up a system for reporting adverse events and incidents involving the device to the MDCO.
• Maintain Compliance with QMS: Continue to adhere to the established QMS, conducting regular audits and reviews to ensure ongoing compliance.

8. Periodic Updates and Renewals

• Periodic Review: Be prepared to conduct periodic reviews and updates of the technical documentation, QMS, and risk management files.
• Communicate Changes: Notify the MDCO of any significant changes to the device or its manufacturing process that may impact safety or efficacy.

Conclusion

The MDACS registration process for Class III in vitro diagnostic medical devices requires careful preparation and adherence to regulatory requirements. By following these steps and maintaining compliance throughout the application and post-registration phases, manufacturers can successfully navigate the registration process and ensure the safety and effectiveness of their devices in the market.

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