To apply for Class III medical device MDACS registration in Hong Kong, follow these steps:

📝 Step-by-Step Process for MDACS Registration (Class III)

1. Confirm Device Classification:

   • Ensure your device qualifies as Class III (high-risk medical device) as per MDACS guidelines.

2. Appoint Local Responsible Person (LRP):

   • The manufacturer must designate a Hong Kong-based entity (a legal representative) to act as the Local Responsible Person (LRP). The LRP will handle the submission and communicate with the Medical Device Division (MDD) on your behalf.

3. Prepare Documents:

   • Gather the required documents (as listed in previous answers). Make sure they are properly organized, translated (if necessary), and meet all regulatory standards.

4. Complete the Application Form (MDRR-1):

   • Fill out the official MDRR-1 form, which is required to list your device in the MDACS system.

5. Submit Application:

   • Submit the completed application (along with all supporting documents) to the Medical Device Division (MDD), Department of Health.

📍 Where to Submit the Application

Submission Methods:

1. By Email (Preferred):

   • Email Address: mdd@dh.gov.hk

   • Attach all documents in PDF format and include the subject:
     MDACS Device Listing Application – Class III – [Device Name]

2. In Person / By Post:

   • Address: Medical Device Division (MDD)
     Department of Health
     Units 2-3, 13/F, Millennium City 6
     392 Kwun Tong Road, Kwun Tong, Kowloon, Hong Kong

   • Submit your physical copies to the above address.

📑 Documents to Include in the Application (Summary)

• MDRR-1 form (completed and signed)

• Device Description and Classification Justification

• Regulatory Approvals (CE, FDA, TGA, etc.)

• Free Sale Certificate

• ISO 13485 Certificate

• Essential Technical Documents (e.g., IFU, labeling, technical specifications)

• Clinical Evaluation Report (for high-risk devices)

• Post-Market Surveillance Plan

• Photos of Device and Packaging

• LRP Authorization Letter and Business Registration Certificate of LRP

📆 Processing Time

After submission, MDACS review typically takes 2-4 months. The timeline may vary depending on the complexity of the device and the completeness of the application.

Contact Us：

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