Where to Submit the Application for Class IV Medical Device Registration under Hong Kong MDACS

All applications for Class IV medical device listing under the Medical Device Administrative Control System (MDACS) must be submitted to the Medical Device Division (MDD) of the Department of Health, Hong Kong.

🔸 Submission Address

Medical Device Division (MDD)
Department of Health
Units 2-3, 11/F, Energy Plaza
92 Granville Road
Tsim Sha Tsui East, Kowloon
Hong Kong

🔸 Submission Methods

1. By Mail or In Person

• Submit hard copies of:

  • Form MD4 (Application for Device Listing)

  • Technical documentation

  • Supporting certificates

  • Authorization letters

  • IFU/labeling materials

• Some documents may also be required in soft copy (e.g., USB or CD-ROM).

2. Email (only for inquiries or follow-up, not full submission)

• For general inquiries or updates:

  • 📧 Email: mdd@dh.gov.hk

  • ☎ Phone: +852 3107 8484 (general enquiry)

🔸 Tips for Submission

• Ensure the Local Responsible Person (LRP) is registered and submitting on behalf of the manufacturer.

• All documents should be in English or Chinese.

• Attach a cover letter summarizing the application contents and the list of enclosed documents.

• Follow the guidance in GN-02 (Guidance Notes for Listing Class II/III/IV Medical Devices).

Contact Us：

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