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Where to apply for Class A medical device registration under Hong Kong MDACS?
Release time：2025-05-14 14:04:17 The author: source:
To apply for Class A medical device registration under the Hong Kong Medical Device Administrative Control System (MDACS), the application must be submitted to the Medical Device Division (MDD) of the Department of Health.

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

🏢 Submission Location & Contact

Submission Method:
➡️ Applications must be submitted in person or by post.
⛔️ Online submission is not available as of 2025.

📮 Mailing / In-Person Submission Address:

Medical Device Division (MDD)
Department of Health
Room 3101, 31st Floor, Hopewell Centre
183 Queen’s Road East
Wan Chai, Hong Kong SAR

📞 Contact Information

📄 Application Forms & Resources

You will need to submit:

  1. MD-TRF (Medical Device Listing Form) – For Class A Devices

  2. Supporting Documents – Including labeling, IFU, manufacturer details, and classification rationale

  3. MD-LRP Form – If your Local Responsible Person (LRP) is not yet registered

All forms and guidance notes are available for download from the MDACS official website under the “Forms and Guidance Notes” section.

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Contact Us：

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


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