The application process for MDACS (Medical Device Administrative Control System) registration of Class III in vitro diagnostic (IVD) medical devices in Hong Kong involves several structured steps. Here’s a detailed outline of the processes involved:

1. Pre-Application Preparation

• Research Regulations: Familiarize yourself with the MDACS guidelines specific to Class III IVD devices as set out by the Medical Device Control Office (MDCO).
• Device Classification Confirmation: Verify that your device qualifies as Class III based on its intended use and associated risks.
• Quality Management System (QMS): Establish a compliant QMS based on ISO 13485, including documentation of processes related to design, production, and post-market activities.

2. Gather Required Documentation

• Compile Technical Documentation: Prepare a comprehensive technical file that includes:
  • Device description and intended use.
  • Design and manufacturing specifications.
  • Clinical evidence demonstrating safety and efficacy.
  • Risk management documentation per ISO 14971.
  • Labeling, instructions for use (IFU), and packaging information.
• Clinical Evaluation Report (CER): If applicable, prepare a clinical evaluation report that summarizes the clinical evidence supporting the device's intended use.

3. Complete the MDACS Application Form

• Obtain Application Form: Download the MDACS application form from the MDCO website.
• Fill Out the Form: Provide all required information accurately, ensuring that it reflects the details of the device and its intended use.

4. Prepare Application Package

• Compile Application Documents: Assemble the application form and all supporting documents into a coherent application package.
• Check for Completeness: Conduct a thorough review to ensure that all necessary documents are included and properly formatted.

5. Submit Application to MDCO

• Submission Methods: Submit the completed application package to the MDCO via their designated submission portal or in person, as specified by the guidelines.
• Pay Application Fees: Ensure that all required fees associated with the application are paid at the time of submission.

6. MDCO Review Process

• Initial Screening: After submission, the MDCO conducts an initial screening to check the completeness of the application.
• Detailed Assessment: The MDCO performs a detailed evaluation of the technical documentation, which includes:
  • Reviewing clinical data and performance claims.
  • Assessing the risk management file.
  • Verifying compliance with quality management standards.
• Request for Additional Information: If the MDCO identifies any issues or requires clarification, they will issue a request for additional information to the applicant.

7. Responding to MDCO Queries

• Provide Additional Information: Address any requests for clarification or additional documentation promptly to avoid delays in the review process.
• Maintain Communication: Keep open lines of communication with the MDCO for updates and clarifications.

8. Approval or Rejection Notification

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

9. Post-Registration Requirements

• Post-Market Surveillance: After approval, implement a post-market surveillance plan to monitor the device’s performance and safety.
• Adverse Event Reporting: Establish a system for reporting any adverse events or incidents related to the device to the MDCO.

10. Periodic Review and Updates

• Regularly Review Documentation: Conduct periodic reviews of the technical documentation, risk management files, and QMS to ensure ongoing compliance.
• Notify MDCO of Significant Changes: Communicate any significant changes in the device or manufacturing processes to the MDCO, assessing if re-registration is necessary.

Conclusion

The MDACS registration process for Class III IVD devices involves meticulous preparation, thorough documentation, and adherence to regulatory requirements. By following these application processes and maintaining effective communication with the MDCO, manufacturers can navigate the registration process effectively, ensuring the safety and efficacy of their medical devices in the market.

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