Handling the registration of Class II in vitro diagnostic (IVD) medical devices in Hong Kong under the Medical Device Administrative Control System (MDACS) involves a series of structured steps. Here’s how to effectively manage the registration process:

Step-by-Step Guide

1. Understand Regulatory Requirements

   • Familiarize yourself with the Medical Device Ordinance (Cap. 663) and the specific guidelines for Class II IVDs provided by MDACS.

2. Confirm Device Classification

   • Verify that your device is correctly classified as Class II IVD. Review the classification criteria to ensure compliance.

3. Prepare Technical Documentation

   • Gather essential documentation, including:
     • Device description and intended use
     • Labeling and Instructions for Use (IFU)
     • Safety and performance data
     • Risk management documentation (ISO 14971)
     • Quality Management System (QMS) evidence (ISO 13485)
     • Manufacturing and validation information

4. Conduct Clinical Evaluations (if applicable)

   • If required, perform clinical evaluations or studies to support claims of safety and efficacy.

5. Create MDACS Account

   • Register for an account on the MDACS online submission platform to facilitate application submission.

6. Complete Application Form

   • Fill out the application form accurately, ensuring all required fields are completed.

7. Submit Application

   • Submit the completed application along with all prepared technical documentation and pay the applicable registration fee.

8. Initial Review Process

   • Be prepared for the MDACS to conduct an initial review to check for completeness. Respond promptly to any requests for additional information.

9. Technical Review and Evaluation

   • During this stage, the Department of Health will evaluate your application in detail. Ensure all safety, performance, and compliance data are readily accessible for review.

10. Respond to Queries

    • If the MDACS raises any questions or requests further information, respond quickly and thoroughly to avoid delays.

11. Receive Approval

    • If the application is approved, you will receive a registration certificate, allowing you to market the device in Hong Kong.

12. Post-Market Surveillance

    • Implement a post-market surveillance plan to monitor the device’s performance, manage adverse events, and maintain compliance with ongoing regulatory requirements.

13. Maintain Documentation and Compliance

    • Keep all records organized and up to date, and ensure continuous compliance with applicable standards and regulations.

Summary

To handle the registration of Class II IVDs in Hong Kong, familiarize yourself with regulatory requirements, prepare comprehensive technical documentation, submit a complete application through the MDACS platform, and respond promptly to any inquiries. After receiving approval, maintain a robust post-market surveillance system and ensure ongoing compliance with all regulatory obligations.

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