The Medical Device Administrative Control System (MDACS) is Hong Kong’s voluntary registration system managed by the Medical Device Control Office (MDCO) under the Department of Health (DH).

If you want to register a Class II medical device under MDACS, here is the full application process:

Step-by-Step Application Process

Step 1: Confirm Device Classification

• Verify that your device is Class II according to the MDACS classification rules (similar to GHTF/IMDRF guidance).

Step 2: Appoint a Local Responsible Person (LRP) (if necessary)

• If the manufacturer is not based in Hong Kong, you must appoint a Local Responsible Person (LRP).

• The LRP must have a Hong Kong business registration.

Step 3: Prepare the Application Documents

Prepare the complete set of documents, including:

• Application Form (Form MD-1)

• Manufacturer Information (e.g., ISO 13485, Certificate of Free Sale)

• Device Description and Technical Documents

• Evidence of Safety and Performance (e.g., CE Mark, FDA 510(k))

• Clinical Evidence (if needed)

• Label Samples

• Risk Analysis (per ISO 14971)

• Declaration of Conformity

• Authorized Representative Appointment Letter (if applicable)

(If you want a full checklist, I can give you one.)

Step 4: Submit the Application

• You submit the application to the Medical Device Control Office (MDCO).

There are two ways to submit:

• Physically: Submit printed documents by hand or courier to the MDCO office.

• Electronically (if allowed): Through the Department of Health's Medical Device System (if you or your LRP is registered).

Step 5: Application Review

• MDCO officers will review the application for completeness, consistency, and compliance.

• They may ask for additional information if needed (you will get a notification).

Step 6: Device Listing

• If approved, your medical device will be listed in the List of Medical Devices on the Hong Kong Department of Health website.

• You will receive an official Device Listing Certificate.

📍 Where to Apply

Medical Device Control Office (MDCO)
Address:
Room 3101, 31/F, Hopewell Centre, 183 Queen’s Road East, Wan Chai, Hong Kong

Official Website:
https://www.mdco.gov.hk

🔔 Key Reminders

• MDACS registration is currently voluntary but highly recommended for market acceptance in hospitals, clinics, and tenders.

• Make sure all certificates (like CE, ISO 13485) are valid at the time of application.

• The processing time is typically 6–9 months but can vary depending on the completeness of your file and MDCO workload.

Contact Us：

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