🇭🇰 What is Class B Medical Device MDACS Registration in Hong Kong?

The Medical Device Administrative Control System (MDACS) is a voluntary registration system implemented by the Medical Device Division (MDD) of Hong Kong’s Department of Health to regulate the safety and quality of medical devices in Hong Kong.

🔷 What is a Class B Medical Device?

Class B devices are low-to-medium risk medical devices (according to MDACS classification rules). Examples include:

• Thermometers

• Suction equipment

• Surgical lights

• Infusion pumps (without high risk)

• Examination gloves

The classification is based on factors such as invasiveness, duration of use, and risk to patients.

🔷 What is MDACS Registration?

MDACS registration means listing the medical device in Hong Kong’s “List of Medical Devices”, confirming:

• It meets recognized safety and performance standards

• It has prior approval from established regulatory authorities (e.g., CE, FDA, TGA)

• It is supported by an appropriate quality system (e.g., ISO 13485)

While not legally mandatory, MDACS registration is required for:

• Government and Hospital Authority tenders

• Establishing local credibility

• Risk management and traceability

📝 How to Apply for MDACS Class B Registration?

1. Appoint a Local Responsible Person (LRP)

Only an LRP, a Hong Kong-registered company/person, can submit the application. The LRP:

• Acts on behalf of the manufacturer

• Is legally responsible for the device in Hong Kong

• Must be registered under MDACS using Form MD-TR

2. Classify the Device (Class B)

Ensure the device is correctly classified according to MDACS classification rules (based on GHTF guidelines).

3. Prepare the Required Documents

Submit Form MD1 (Device Listing Application) with supporting materials:

A. Device Information

• Model name(s), intended use, accessories

• Instructions for use and labels in English/Chinese

B. Manufacturer Information

• Company name, address, and contact info

C. Regulatory Approval Proof (any one of):

• CE Marking (EU MDD/MDR)

• FDA 510(k) or PMA

• TGA ARTG listing (Australia)

• Health Canada License

• Japan PMDA approval

If none are available, submit full technical documentation (risk management, testing, clinical evaluation, etc.)

D. Quality Management System

• ISO 13485 certificate of manufacturer (valid & accredited)

E. Declaration of Conformity

• Signed by manufacturer, stating compliance with applicable standards

4. Submit the Application

• Submit Form MD1 and required documents in hard copy to:

Medical Device Division, Department of Health
14/F, Guardian House, 32 Oi Kwan Road, Wan Chai, Hong Kong

• Pay the application fee (usually HK$500 per device; confirm with MDD)

5. Review Process

• MDD will verify the documentation

• May request further information

• Processing time varies (usually 1–3 months)

6. Device Listing

Once approved, the device is:

• Assigned a listing number

• Published in the “List of Medical Devices” on the Department of Health website

• Allowed to be marketed in Hong Kong under MDACS

📌 Summary Flowchart

Contact Us：

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