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How to apply for MDACS registration for Class IV in vitro diagnostic medical devices? Where to do it?
Release time：2024-10-28 11:16:49 The author: source:
Confirm that your IVD device is classified as Class IV, which is typically for high-risk devices. Ensure you understand the specific regulatory requirements for this classification.

To apply for MDACS (Medical Device Administrative Control System) registration for Class IV in vitro diagnostic (IVD) medical devices in Hong Kong, follow these steps:

Step-by-Step Application Process

  1. Determine Device Classification:

    • Confirm that your IVD device is classified as Class IV, which is typically for high-risk devices. Ensure you understand the specific regulatory requirements for this classification.

  2. Prepare Documentation:

    • Gather all necessary documentation as outlined in previous responses. This includes:
      • Completed MDACS application form.
      • Technical documentation detailing the device’s design, manufacturing, and performance.
      • Clinical evidence demonstrating safety and effectiveness.
      • Quality management system (QMS) documentation (ISO 13485 compliance).
      • Proposed labeling and instructions for use.
      • Manufacturer information.
      • Payment receipt for application fees.

  3. Online Submission:

    • MDCO Online Application Portal: The primary method for submitting your application is through the MDCO’s online application system. You can find the portal on the MDCO website.
    • Website: Medical Device Control Office (MDCO)

  4. Postal Submission (if needed):

    • If online submission is not feasible, you can submit your application by postal mail. Ensure all documents are organized and complete.

  1. Pay Application Fees:

    • Ensure that you include the required application fee with your submission. Payment methods and amounts can be found on the MDCO website.

  2. MDCO Review:

    • After submission, the MDCO will review your application. This process typically takes 60 to 90 days, although it may vary depending on the complexity of your application and the volume of submissions being processed.

  3. Respond to Queries:

    • Be prepared to respond to any inquiries or requests for additional information from the MDCO during the evaluation process.

  4. Approval:

    • If your application meets all requirements, the MDCO will grant registration for your Class IV IVD device, allowing it to be marketed in Hong Kong.

Where to Apply

  • Primary Application Location:
    • Online: MDCO's official online application portal (accessible through the MDCO website).
    • In-Person or Postal: Submit applications and documents directly to the MDCO office at the address mentioned above.

Additional Resources

  • Guidelines and Regulations: Review the guidelines and regulations related to Class IV IVD devices on the MDCO website to ensure compliance with all requirements.
  • Contact Information: If you have questions or need assistance, you can contact the MDCO directly:

By following these steps and submitting your application through the appropriate channels, you can successfully apply for MDACS registration for your Class IV in vitro diagnostic medical device in Hong Kong.

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