To apply for Class IV medical device registration under Hong Kong MDACS, you need to submit your application to the Medical Device Division (MDD) of the Department of Health (DH) in Hong Kong.

Steps to Apply:

1. Submit the Application to the MDD:

   • You will need to submit the completed MD-APP registration form along with the necessary documentation (e.g., evidence of regulatory approval, quality management certifications, clinical data, and risk management) to the MDD.

2. Documents to Prepare:

   • Device description and labeling.

   • Clinical evaluation reports or studies.

   • Quality management system certification (ISO 13485).

   • Risk management documentation.

   • Evidence of approval in other jurisdictions (CE, FDA, etc.).

3. How to Submit:

   • The submission can be done electronically or via hard copy.

   • For electronic submission, you can use the official Hong Kong Department of Health's online platform or send it via email.

   • For hard copy submission, send your documents to the following address:

     Medical Device Division (MDD)
     Department of Health,
     147C Argyle Street,
     Kowloon, Hong Kong.

4. Contact Information:

   • For more details, you can contact the MDD directly via email or phone. Their contact details can typically be found on the Hong Kong Department of Health’s website.

Where to Find More Information:

• Hong Kong Department of Health – MDACS: Official Website

• Application Forms and Guidelines: Available on the Department of Health's website or through direct inquiry with the MDD.

Contact Us：

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