To apply for Class D medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), you need to submit your application to the Medical Device Division (MDD) of the Department of Health in Hong Kong. The MDD is the authority responsible for overseeing the registration and regulation of medical devices under the MDACS.

Application Submission Options:

You can submit your application in person, by mail, or electronically (if applicable). Below are the details:

1. In-Person or Mail Submission

• Address:
  • Medical Device Division, Department of Health
  • Room 3101-3102, 31/F, Hopewell Centre,
  • 183 Queen’s Road East, Wan Chai, Hong Kong.
• Make sure all required documents, forms (MD-14 for Class D devices), and the application fee are included in the submission.

2. Electronic Submission

• As of now, MDACS does not have an extensive online portal, but some forms and communications can be initiated electronically. You should contact the Medical Device Division to inquire if an electronic submission is possible for your particular case.
• Contact details:
  • Phone: (+852) 3107 8484
  • Email: mdd@dh.gov.hk

3. Local Responsible Person (LRP) Submission

• If you are a manufacturer based outside of Hong Kong, you will need to appoint a Local Responsible Person (LRP), who is registered in Hong Kong and will submit the application on your behalf. The LRP handles communication with the MDD and is responsible for post-market surveillance activities as well.

Documents to Include with Your Submission:

• Completed Application Form MD-14.
• Relevant documentation such as a certificate of free sale, declaration of conformity, risk analysis report, clinical data, labeling, and other supporting documents.
• Payment of the application fee.

For further guidance or to clarify any specific requirements, you can directly contact the Medical Device Division.