To apply for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you must follow a specific application process and submit your application to the appropriate authority. Here’s a step-by-step guide on how to apply and where to submit your application:

Steps to Apply for Class D Medical Device Registration

1. Determine Device Classification

• Ensure that your device qualifies as a Class D medical device based on the MDACS classification system. Class D devices are high-risk and include life-sustaining, life-supporting, or implantable devices.

2. Appoint a Local Responsible Person (LRP)

• If you are an overseas manufacturer, appoint a Local Responsible Person (LRP) based in Hong Kong. The LRP will be responsible for submitting the application on your behalf and managing post-market surveillance and communication with the Medical Device Division (MDD).

3. Prepare Required Documentation

• Gather all necessary documentation, including:
  • Completed Application Form MD-14
  • Certificate of Free Sale or equivalent regulatory approval
  • Declaration of Conformity
  • Quality Management System (QMS) certification (ISO 13485)
  • Risk Management Report
  • Clinical Evidence and data
  • Product Description
  • Labeling and Instructions for Use (IFU)
  • Post-Market Surveillance (PMS) Plan
  • Technical Documentation
  • Adverse Event Reporting and Recall Procedures
  • Payment of Application Fee

4. Complete the Application Form

• Fill out the Application Form MD-14 accurately, providing detailed information about the device, the manufacturer, and the LRP (if applicable).
• Ensure the form is signed by an authorized representative of the manufacturer or LRP.

5. Submit the Application

• Where to Apply: The application must be submitted to the Medical Device Division (MDD) of the Department of Health in Hong Kong.
• Submission Methods: You can submit the application:
  • In-person at the MDD office
  • By mail to the address below
  • Electronically if applicable (check with MDD for options)

Address for Submission:

r复制代码Medical Device Division
Department of Health
Room 3101-3102, 31/F, Hopewell Centre183 Queen’s Road East, Wan Chai, Hong Kong

6. Pay the Application Fee

• Include the non-refundable application fee, which for Class D devices typically ranges between HKD 25,000 to HKD 50,000. Payment methods may vary, so check with MDD for acceptable payment options.

7. Await Review and Approval

• The MDD will review your application and may request additional information. The review process can take 6 to 12 months or longer, depending on the complexity of the device and the completeness of your submission.

8. Receive Approval and Listing

• Once approved, your device will be registered in the MDACS database, and you will receive a registration number. The registration is typically valid for five years, after which it must be renewed.

Summary

• Where to Apply: Submit your application to the Medical Device Division (MDD), Department of Health, Hong Kong.
• Address: Room 3101-3102, 31/F, Hopewell Centre, 183 Queen’s Road East, Wan Chai, Hong Kong.
• Contact Information:
  • Phone: (+852) 3107 8484
  • Email: mdd@dh.gov.hk