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

📍 Where to Apply for MDACS Registration

🔹 Submission Method:

MDACS applications must be submitted in hard copy (paper form).

🔹 Submission Address:

Medical Device Division (MDD)
Department of Health
14th Floor, Guardian House
32 Oi Kwan Road
Wan Chai, Hong Kong

📑 What to Submit:

For Class B devices, you need to submit the following:

1. Form MD1 – Device Listing Application Form

2. All supporting documents, such as:

   • CE/FDA/TGA approval certificates

   • ISO 13485 certificate

   • Declaration of Conformity

   • Labels and IFU (in English/Chinese)

   • Letter of appointment for the Local Responsible Person (LRP)

3. Application Fee: HK$500 per device (usually via cheque payable to "The Government of the Hong Kong Special Administrative Region").

🔒 Electronic submission is not accepted. All applications must be printed and signed.

Contact Us：

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