To apply for Class B medical device registration under the Hong Kong MDACS (Medical Device Administrative Control System), you must submit the application to the Medical Device Division (MDD) of the Department of Health, Hong Kong SAR.

🏢 Where to Apply

• Phone: +852 3107 8484

• Email (for general inquiries): mdd@dh.gov.hk

• Website: https://www.mdd.gov.hk

📥 Application Method

• Submission must be made by the Local Responsible Person (LRP).

• All documents should be printed and submitted in hard copy.

• Electronic submissions are not accepted at this time.

• No online application portal is available.

📄 Required Form

• Form MD001 – Application Form for Listing of Medical Devices

  • Available from the MDD website.

  • Must be completed, signed, and submitted with the full supporting documentation.

✅ Important Notes

• Only an LRP based in Hong Kong is allowed to submit the application.

• The LRP must be authorized in writing by the manufacturer (if the manufacturer is overseas).

• Make sure documents are clearly organized and properly labeled to avoid delays in processing.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn