To apply for MDACS registration of Class III in vitro diagnostic medical devices in Hong Kong, follow these steps:

1. Understand the Requirements

• Before applying, familiarize yourself with the MDACS guidelines and requirements specific to Class III IVDs. Ensure that your device meets the classification criteria.

2. Prepare Documentation

• Compile the necessary documents, which typically include:
  • A completed MDACS application form.
  • Technical documentation (device description, design, manufacturing information).
  • Quality management system evidence (ISO 13485 certification).
  • Clinical data demonstrating safety and effectiveness.
  • Labeling and packaging information.
  • Risk management documentation.
  • Payment receipt for application fees.

3. Complete the Application Form

• Obtain the MDACS application form from the Medical Device Control Office (MDCO) website. Fill it out accurately, providing all required details about your device.

4. Submit the Application

• Where to Apply:
  • Submit your application to the Medical Device Control Office (MDCO), which operates under the Department of Health in Hong Kong.
  • You can submit your application either:
    • Online: Through the MDCO’s online submission portal (if available).
    • By Mail: Send your completed application and supporting documents to the MDCO address specified on their website.

5. Pay the Registration Fee

• Pay the applicable registration fees as outlined on the MDCO website. Ensure you include proof of payment with your application.

6. Await Review

• The MDCO will review your application. Be prepared to respond to any requests for additional information or clarification during the review process.

7. Receive Approval

• If your application is approved, you will receive an MDACS registration certificate, allowing you to market your Class III IVD in Hong Kong.

8. Post-Market Obligations

• After receiving registration, ensure compliance with post-market surveillance obligations, including monitoring for adverse events and maintaining quality standards.

Contact Information

For further assistance, you can contact the MDCO directly via their official website or contact details listed there.

Resources

• MDCO Website: MDCO - Drug Office

Following these steps will help ensure a smooth application process for MDACS registration of your Class III in vitro diagnostic medical device.