How to apply for Class B medical device registration under the Hong Kong MDACS and where to do it?

Here's how to apply for Class B medical device registration under the Hong Kong MDACS and where to submit your application:

📝 How to Apply for Class B Medical Device Registration under Hong Kong MDACS

Step 1: Appoint a Local Responsible Person (LRP)

The LRP must be a legal entity based in Hong Kong.
The manufacturer (if overseas) must provide an authorization letter empowering the LRP to act on its behalf.

Step 2: Prepare the Application Package

Complete the MDACS Form MD001 (Application for Device Listing).
Collect all required supporting documents (device description, classification justification, regulatory approvals, labeling, ISO 13485 certificate, risk management summary, etc.).
Organize documents in hard copy (no electronic submission accepted).

Step 3: Submit the Application

The LRP submits the hard copy application package.
Include the completed Form MD001 signed by the LRP.

📍 Where to Submit

Medical Device Division (MDD), Department of Health, Hong Kong SAR

Address:
Medical Device Division
Department of Health
21/F, Wu Chung House
213 Queen’s Road East
Wan Chai, Hong Kong

Contact:

Phone: +852 3107 8484
Email: mdd@dh.gov.hk
Website: https://www.mdd.gov.hk

⏳ Processing Time

Typically 3 to 6 months from the date of submission, depending on completeness and any additional requests.

If you want, I can help you get the application form MD001 or a document checklist to make sure you prepare everything correctly. Would you like that?